Trial | Outcome |
NCT00369343 (13) [back to overview] | Percentage of Patients Achieving Remission |
NCT00369343 (13) [back to overview] | Percentage of Patients Achieving Response to Treatment |
NCT00369343 (13) [back to overview] | Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months |
NCT00369343 (13) [back to overview] | Percentage of Patients Achieving Remission |
NCT00369343 (13) [back to overview] | Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score |
NCT00369343 (13) [back to overview] | Discontinuation-Emergent Signs and Symptoms (DESS) Total Score |
NCT00369343 (13) [back to overview] | Clinical Global Impression Improvement (CGI-I) Score |
NCT00369343 (13) [back to overview] | Percentage of Patients Achieving a Response to Treatment |
NCT00369343 (13) [back to overview] | Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8 |
NCT00369343 (13) [back to overview] | Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8 |
NCT00369343 (13) [back to overview] | Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months |
NCT00369343 (13) [back to overview] | Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months |
NCT00369343 (13) [back to overview] | Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8. |
NCT00384033 (9) [back to overview] | Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation |
NCT00384033 (9) [back to overview] | Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation |
NCT00384033 (9) [back to overview] | Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation |
NCT00384033 (9) [back to overview] | Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation |
NCT00384033 (9) [back to overview] | Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation |
NCT00384033 (9) [back to overview] | Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation |
NCT00384033 (9) [back to overview] | Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation |
NCT00384033 (9) [back to overview] | Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation |
NCT00384033 (9) [back to overview] | Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation |
NCT00401245 (15) [back to overview] | Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment |
NCT00401245 (15) [back to overview] | DESS Total Score at 1 Week After the End of Tapering |
NCT00401245 (15) [back to overview] | DESS Total Score at End of Second Week of Tapering |
NCT00401245 (15) [back to overview] | Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering |
NCT00401245 (15) [back to overview] | Mean Age of the Participants in Tapering Phase |
NCT00401245 (15) [back to overview] | Number of Participants With Nausea During the First 2 Weeks of Treatment |
NCT00401245 (15) [back to overview] | Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment |
NCT00401245 (15) [back to overview] | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering |
NCT00401245 (15) [back to overview] | Number of Participants With Each DESS One Week After End of Tapering |
NCT00401245 (15) [back to overview] | Number of Participants With Each DESS at the End of Second Week of Tapering |
NCT00401245 (15) [back to overview] | Number of Participants With Each DESS at the End of First Week of Tapering |
NCT00401245 (15) [back to overview] | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment |
NCT00401245 (15) [back to overview] | Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score |
NCT00401245 (15) [back to overview] | Gender of the Participants in Tapering Phase |
NCT00401245 (15) [back to overview] | Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16 |
NCT00406640 (13) [back to overview] | Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks |
NCT00406640 (13) [back to overview] | Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8 |
NCT00406640 (13) [back to overview] | Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8 |
NCT00406640 (13) [back to overview] | Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week |
NCT00406640 (13) [back to overview] | Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase) |
NCT00406640 (13) [back to overview] | Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase |
NCT00406640 (13) [back to overview] | Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score |
NCT00406640 (13) [back to overview] | Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase |
NCT00406640 (13) [back to overview] | Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase) |
NCT00406640 (13) [back to overview] | Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase) |
NCT00406640 (13) [back to overview] | Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase |
NCT00406640 (13) [back to overview] | Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase) |
NCT00406640 (13) [back to overview] | Discontinuation-Emergent Signs and Symptoms (DESS) Total Score |
NCT00619619 (9) [back to overview] | Area Under the Curve From Time Zero to Infinity (AUC0-∞) |
NCT00619619 (9) [back to overview] | Time to Reach Maximum Observed Plasma Concentration (Tmax) |
NCT00619619 (9) [back to overview] | Plasma Decay Half-Life (t1/2) |
NCT00619619 (9) [back to overview] | Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit |
NCT00619619 (9) [back to overview] | Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs) |
NCT00619619 (9) [back to overview] | Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit |
NCT00619619 (9) [back to overview] | Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score |
NCT00619619 (9) [back to overview] | Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score |
NCT00619619 (9) [back to overview] | Maximum Observed Plasma Concentration (Cmax) |
NCT00669110 (16) [back to overview] | Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score |
NCT00669110 (16) [back to overview] | Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score |
NCT00669110 (16) [back to overview] | Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Weight |
NCT00669110 (16) [back to overview] | Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate |
NCT00669110 (16) [back to overview] | Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP) |
NCT00669110 (16) [back to overview] | Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI) |
NCT00669110 (16) [back to overview] | Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score |
NCT00669110 (16) [back to overview] | Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI) |
NCT00669110 (16) [back to overview] | Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs) |
NCT00669110 (16) [back to overview] | Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males |
NCT00669110 (16) [back to overview] | Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females |
NCT00669110 (16) [back to overview] | Change From Baseline (Bsl) in Children's Depression Rating Scale - Revised (CDRS-R) Total Score at Final On-therapy Visit |
NCT00669110 (16) [back to overview] | Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI): Heart Rate (Low) |
NCT00669110 (16) [back to overview] | Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories |
NCT00669110 (16) [back to overview] | Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R) |
NCT00669110 (16) [back to overview] | Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score |
NCT00683800 (30) [back to overview] | Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4 |
NCT00683800 (30) [back to overview] | Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes |
NCT00683800 (30) [back to overview] | Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes |
NCT00683800 (30) [back to overview] | Number of Participants With Adjudicated Cerebrovascular Events - Probable TIA |
NCT00683800 (30) [back to overview] | Number of Participants With Hepatic Events |
NCT00683800 (30) [back to overview] | Number of Participants With Ischemic Heart Disease |
NCT00683800 (30) [back to overview] | Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12 |
NCT00683800 (30) [back to overview] | Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12 |
NCT00683800 (30) [back to overview] | Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12 |
NCT00683800 (30) [back to overview] | Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6 |
NCT00683800 (30) [back to overview] | Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12 |
NCT00683800 (30) [back to overview] | Number of Participants With Adjudicated Cerebrovascular Events - Any Stroke |
NCT00683800 (30) [back to overview] | Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events |
NCT00683800 (30) [back to overview] | Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes |
NCT00683800 (30) [back to overview] | Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes |
NCT00683800 (30) [back to overview] | Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12 |
NCT00683800 (30) [back to overview] | Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12 |
NCT00683800 (30) [back to overview] | Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6 |
NCT00683800 (30) [back to overview] | Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12 |
NCT00683800 (30) [back to overview] | Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6 |
NCT00683800 (30) [back to overview] | Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12 |
NCT00683800 (30) [back to overview] | Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12 |
NCT00683800 (30) [back to overview] | Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6 |
NCT00683800 (30) [back to overview] | Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12 |
NCT00683800 (30) [back to overview] | Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12 |
NCT00683800 (30) [back to overview] | Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6 |
NCT00683800 (30) [back to overview] | Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12 |
NCT00683800 (30) [back to overview] | Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12 |
NCT00683800 (30) [back to overview] | Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4 |
NCT00683800 (30) [back to overview] | Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12 |
NCT00696787 (2) [back to overview] | Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients |
NCT00696787 (2) [back to overview] | Change From Baseline on the Numeric Rating Scale (NRS) |
NCT00727064 (6) [back to overview] | Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of DVS SR by Metabolizer Status |
NCT00727064 (6) [back to overview] | Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status |
NCT00727064 (6) [back to overview] | Area Under the Concentration-time Curve (AUC) of Venlafaxine After Single Dose of VEN ER by Metabolizer Status |
NCT00727064 (6) [back to overview] | Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of Desvenlafaxine Succinate Sustained-Release (DVS SR) by Metabolizer Status |
NCT00727064 (6) [back to overview] | Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status |
NCT00727064 (6) [back to overview] | Maximum Concentration (Cmax) of Venlafaxine After Single Dose of Venlafaxine Extended-release (VEN ER) by Metabolizer Status |
NCT00797966 (14) [back to overview] | Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit). |
NCT00797966 (14) [back to overview] | Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit). |
NCT00797966 (14) [back to overview] | Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction). |
NCT00797966 (14) [back to overview] | Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score. |
NCT00797966 (14) [back to overview] | Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score. |
NCT00797966 (14) [back to overview] | Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication). |
NCT00797966 (14) [back to overview] | Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (QLES-Q-SF) Subscale Score - the Overall General Subscore (Sum of First 14 Items). |
NCT00797966 (14) [back to overview] | Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores). |
NCT00797966 (14) [back to overview] | Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score. |
NCT00797966 (14) [back to overview] | Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score. |
NCT00797966 (14) [back to overview] | Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit. |
NCT00797966 (14) [back to overview] | Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit. |
NCT00797966 (14) [back to overview] | Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B. |
NCT00797966 (14) [back to overview] | Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit). |
NCT00798707 (14) [back to overview] | Discontinuation-Emergent Signs and Symptoms (DESS) Total Score |
NCT00798707 (14) [back to overview] | Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET) |
NCT00798707 (14) [back to overview] | Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET) |
NCT00798707 (14) [back to overview] | Change From Baseline in SDS at FOT Evaluation (Week 8 or ET) |
NCT00798707 (14) [back to overview] | Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET) |
NCT00798707 (14) [back to overview] | Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET) |
NCT00798707 (14) [back to overview] | Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET) |
NCT00798707 (14) [back to overview] | Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET) |
NCT00798707 (14) [back to overview] | Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET) |
NCT00798707 (14) [back to overview] | Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET) |
NCT00798707 (14) [back to overview] | Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET) |
NCT00798707 (14) [back to overview] | Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET) |
NCT00798707 (14) [back to overview] | Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET) |
NCT00798707 (14) [back to overview] | Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET) |
NCT00824291 (8) [back to overview] | Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12 |
NCT00824291 (8) [back to overview] | Change From Baseline on Work and Activities Item of HAM-D17 at Week 12 |
NCT00824291 (8) [back to overview] | Change From Baseline on Stress and Social Support Scales at Week 12 |
NCT00824291 (8) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12 |
NCT00824291 (8) [back to overview] | Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12 |
NCT00824291 (8) [back to overview] | Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12 |
NCT00824291 (8) [back to overview] | Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12 |
NCT00824291 (8) [back to overview] | Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12 |
NCT00831415 (4) [back to overview] | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score |
NCT00831415 (4) [back to overview] | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score |
NCT00831415 (4) [back to overview] | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) |
NCT00831415 (4) [back to overview] | Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I) |
NCT00863798 (14) [back to overview] | Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET) |
NCT00863798 (14) [back to overview] | Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET) |
NCT00863798 (14) [back to overview] | Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET) |
NCT00863798 (14) [back to overview] | Discontinuation-Emergent Signs and Symptoms (DESS) |
NCT00863798 (14) [back to overview] | Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET) |
NCT00863798 (14) [back to overview] | Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET) |
NCT00863798 (14) [back to overview] | Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET) |
NCT00863798 (14) [back to overview] | Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET) |
NCT00863798 (14) [back to overview] | Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET) |
NCT00863798 (14) [back to overview] | Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET) |
NCT00863798 (14) [back to overview] | Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET) |
NCT00863798 (14) [back to overview] | Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET) |
NCT00863798 (14) [back to overview] | Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET) |
NCT00863798 (14) [back to overview] | Change From Baseline in SDS at FOT Evaluation (Week 8 or ET) |
NCT00887224 (8) [back to overview] | Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26 |
NCT00887224 (8) [back to overview] | Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185 |
NCT00887224 (8) [back to overview] | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase |
NCT00887224 (8) [back to overview] | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase |
NCT00887224 (8) [back to overview] | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase |
NCT00887224 (8) [back to overview] | Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index |
NCT00887224 (8) [back to overview] | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale |
NCT00887224 (8) [back to overview] | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase |
NCT00952653 (10) [back to overview] | Midazolam Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR |
NCT00952653 (10) [back to overview] | Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR |
NCT00952653 (10) [back to overview] | Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR |
NCT00952653 (10) [back to overview] | 1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR |
NCT00952653 (10) [back to overview] | 1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR |
NCT00952653 (10) [back to overview] | 1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR |
NCT00952653 (10) [back to overview] | 1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR |
NCT00952653 (10) [back to overview] | 1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR |
NCT00952653 (10) [back to overview] | Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR |
NCT00952653 (10) [back to overview] | Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR |
NCT01056289 (3) [back to overview] | Percentage of Participants Who Were Unable to Successfully Complete Tapering of the Study Drug Because of the Number and/or Severity of Their Discontinuation Symptoms |
NCT01056289 (3) [back to overview] | Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase |
NCT01056289 (3) [back to overview] | Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase |
NCT01121484 (6) [back to overview] | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) |
NCT01121484 (6) [back to overview] | Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8 |
NCT01121484 (6) [back to overview] | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8 |
NCT01121484 (6) [back to overview] | Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR) |
NCT01121484 (6) [back to overview] | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8 |
NCT01121484 (6) [back to overview] | Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8 |
NCT01188668 (12) [back to overview] | Dehydro-aripiprazole (Metabolite) Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR |
NCT01188668 (12) [back to overview] | Plasma Dehydro-aripiprazole (Metabolite) Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg, Aripiprazole 5 mg |
NCT01188668 (12) [back to overview] | Aripiprazole Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR |
NCT01188668 (12) [back to overview] | Plasma Aripiprazole Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg + Aripiprazole 5 mg |
NCT01188668 (12) [back to overview] | Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR |
NCT01188668 (12) [back to overview] | Aripiprazole Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR |
NCT01188668 (12) [back to overview] | Aripiprazole Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR |
NCT01188668 (12) [back to overview] | Aripiprazole Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR |
NCT01188668 (12) [back to overview] | Dehydro-aripiprazole (Metabolite) Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR |
NCT01188668 (12) [back to overview] | Dehydro-aripiprazole (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR |
NCT01188668 (12) [back to overview] | Dehydro-aripiprazole (Metabolite) Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR |
NCT01188668 (12) [back to overview] | Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | Tamoxifen Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | Tamoxifen Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | Tamoxifen Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | Tamoxifen Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | 4-hydroxy-tamoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | 4-hydroxy-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | 4-hydroxy-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | 4-hydroxy-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | Endoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Endoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | Endoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | Endoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | Endoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | N-desmethyl-tamoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | N-desmethyl-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | N-desmethyl-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | N-desmethyl-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | Tamoxifen Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01189500 (22) [back to overview] | Tamoxifen Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR |
NCT01190514 (6) [back to overview] | Time to Reach Maximum Observed Plasma Concentration (Tmax) |
NCT01190514 (6) [back to overview] | Terminal Elimination Half-life (t 1/2) |
NCT01190514 (6) [back to overview] | Maximum Plasma Concentration (Cmax) |
NCT01190514 (6) [back to overview] | Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48) |
NCT01190514 (6) [back to overview] | Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast) |
NCT01190514 (6) [back to overview] | Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) |
NCT01316302 (3) [back to overview] | Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score |
NCT01316302 (3) [back to overview] | Clinical Global Impression of Improvement Scale (CGI-I) |
NCT01316302 (3) [back to overview] | Patient Global Impression of Change |
NCT01353963 (7) [back to overview] | Change From Baseline in Weight at Week 8. |
NCT01353963 (7) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) |
NCT01353963 (7) [back to overview] | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8. |
NCT01353963 (7) [back to overview] | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4. |
NCT01353963 (7) [back to overview] | Change From Baseline in Weight at Week 4. |
NCT01353963 (7) [back to overview] | Change From Baseline in Heart Rate at Week 8. |
NCT01353963 (7) [back to overview] | Change From Baseline in Heart Rate at Week 4. |
NCT01371734 (4) [back to overview] | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 |
NCT01371734 (4) [back to overview] | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' |
NCT01371734 (4) [back to overview] | Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106) |
NCT01371734 (4) [back to overview] | Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106) |
NCT01372150 (4) [back to overview] | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' |
NCT01372150 (4) [back to overview] | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 |
NCT01372150 (4) [back to overview] | Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score |
NCT01372150 (4) [back to overview] | Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score |
NCT01432457 (8) [back to overview] | Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score |
NCT01432457 (8) [back to overview] | Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score |
NCT01432457 (8) [back to overview] | Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S) |
NCT01432457 (8) [back to overview] | Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 |
NCT01432457 (8) [back to overview] | Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 |
NCT01432457 (8) [back to overview] | Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate |
NCT01432457 (8) [back to overview] | Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate |
NCT01432457 (8) [back to overview] | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) |
NCT01537068 (3) [back to overview] | Response Rate |
NCT01537068 (3) [back to overview] | Hamilton Rating Scale for Depression (HDRS24) |
NCT01537068 (3) [back to overview] | Hamilton Rating Scale for Depression (HDRS24) |
NCT01916824 (1) [back to overview] | Money Earned |
NCT04476030 (16) [back to overview] | Change From Baseline in Depressive Symptoms at Day 15, as Assessed by PHQ-9 |
NCT04476030 (16) [back to overview] | Change From Baseline in CGI-S Score at Day 15 |
NCT04476030 (16) [back to overview] | Change From Baseline in HAM-A Total Score at Day 15 |
NCT04476030 (16) [back to overview] | Percentage of Participants With HAMD-17 Remission at Day 15 and Day 42 |
NCT04476030 (16) [back to overview] | Percentage of Participants With CGI-I Response, at Day 3 and Day 15 |
NCT04476030 (16) [back to overview] | Change From Baseline in the HAMD-17 Total Score at Days 15 and 42 |
NCT04476030 (16) [back to overview] | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
NCT04476030 (16) [back to overview] | Percentage of Participants With TEAEs, Graded by Severity |
NCT04476030 (16) [back to overview] | Percentage of Participants With HAMD-17 Response at Day 15 and Day 42 |
NCT04476030 (16) [back to overview] | Time to First HAMD-17 Response |
NCT04476030 (16) [back to overview] | Percentage of Participants With MADRS Response at Day 15 |
NCT04476030 (16) [back to overview] | Percentage of Participants With MADRS Remission at Day 15 |
NCT04476030 (16) [back to overview] | Change From Baseline in the HAMD-17 Total Score at Day 3 |
NCT04476030 (16) [back to overview] | Change From Baseline in the HAMD-17 Total Score Around End of Blinded Treatment |
NCT04476030 (16) [back to overview] | Change From Baseline in MADRS Total Score at Day 15 |
NCT04476030 (16) [back to overview] | Change From Baseline in the HAMD-17 Total Score Over the Double-Blind Treatment Period |
Percentage of Patients Achieving Remission
Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. (NCT00369343)
Timeframe: 8 weeks
Intervention | percentage of patients (Number) |
---|
Desvenlafaxine Succinate Sustained-Release (DVS SR) | 38.2 |
Placebo | 22.4 |
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Percentage of Patients Achieving Response to Treatment
A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. (NCT00369343)
Timeframe: 8 weeks
Intervention | percentage of patients (Number) |
---|
Desvenlafaxine Succinate Sustained-Release (DVS SR) | 58.6 |
Placebo | 31.6 |
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Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50. Change= Final Evaluation mean HAM-D17 minus baseline mean HAM-D17. (NCT00369343)
Timeframe: open label baseline and 6 months
Intervention | units on scale (Mean) |
---|
DVS SR / DVS SR | -12.52 |
Placebo / DVS SR | -12.45 |
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Percentage of Patients Achieving Remission
Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50. (NCT00369343)
Timeframe: 6 months
Intervention | percentage of patients (Number) |
---|
DVS SR / DVS SR | 55.6 |
Placebo / DVS SR | 48.5 |
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Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse). (NCT00369343)
Timeframe: 8 weeks
Intervention | percentage of patients (Number) |
---|
| 1 (very much improved) | 2 (much improved) | 3 (minimally improved) | 4 (no change) | 5 (minimally worse) | 6 (much worse) | 7 (very much worse) |
---|
Desvenlafaxine Succinate Sustained-Release (DVS SR) | 42.5 | 25.3 | 16.7 | 13.4 | 1.1 | 0.5 | 0.5 |
,Placebo | 22.7 | 18.6 | 17.5 | 32.0 | 7.2 | 2.1 | 0.0 |
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Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms." (NCT00369343)
Timeframe: 6 months
Intervention | units on scale (Mean) |
---|
| End of 8 week DB / OL phase or early termination | Taper week 1 | Taper week 2 | Post-taper |
---|
0 mg | 4.00 | 2.00 | 1.40 | 0.60 |
,100 mg | 2.07 | 3.32 | 5.29 | 1.41 |
,200 mg | 1.27 | 2.47 | 3.76 | 2.46 |
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Clinical Global Impression Improvement (CGI-I) Score
CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse) (NCT00369343)
Timeframe: 6 months
Intervention | units on scale (Mean) |
---|
DVS SR / DVS SR | 1.55 |
Placebo / DVS SR | 1.56 |
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Percentage of Patients Achieving a Response to Treatment
A responder is defined as a patient with ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression - 17-item (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. (NCT00369343)
Timeframe: 6 months
Intervention | percentage of patients responding (Number) |
---|
DVS SR / DVS SR | 70.5 |
Placebo / DVS SR | 66.0 |
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Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8
The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A score minus baseline adjusted mean score. (NCT00369343)
Timeframe: Baseline to 8 weeks
Intervention | units on scale (Mean) |
---|
Desvenlafaxine Succinate Sustained-Release (DVS SR) | -8.62 |
Placebo | -5.89 |
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Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8
EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score. (NCT00369343)
Timeframe: Baseline to 8 weeks
Intervention | units on scale (Mean) |
---|
Desvenlafaxine Succinate Sustained-Release (DVS SR) | 0.18 |
Placebo | 0.06 |
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Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months
EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score. (NCT00369343)
Timeframe: open label baseline to 6 months
Intervention | units on scale (Mean) |
---|
DVS SR / DVS SR | 0.19 |
Placebo / DVS SR | 0.22 |
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Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months
The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= Final Evaluation mean HAM-A score minus baseline mean score. (NCT00369343)
Timeframe: open label baseline to 6 months
Intervention | units on scale (Mean) |
---|
DVS SR / DVS SR | -10.95 |
Placebo / DVS SR | -10.38 |
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Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17 (NCT00369343)
Timeframe: Baseline to 8 weeks
Intervention | units on scale (Mean) |
---|
Desvenlafaxine Succinate Sustained-Release (DVS SR) | -12.64 |
Placebo | -8.33 |
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Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale relative to the baseline assessment. Higher score = more affected. (NCT00384033)
Timeframe: Week 8 or FOT
Intervention | Participants (Number) |
---|
| 1 = Very much improved | 2 = Much improved | 3 = Minimally improved | 4 = No change | 5 = Minimally worse |
---|
Duloxetine 60 mg | 45 | 35 | 37 | 37 | 3 |
,DVS SR 100 mg | 45 | 37 | 28 | 37 | 2 |
,DVS SR 50 mg | 27 | 38 | 47 | 34 | 2 |
,Placebo | 31 | 32 | 35 | 57 | 5 |
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Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation
HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50. (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | Units on a Scale (Mean) |
---|
Placebo | -8.68 |
DVS SR 50 mg | -9.75 |
DVS SR 100 mg | -10.5 |
Duloxetine 60 mg | -10.3 |
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Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected. (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | Units on a Scale (Mean) |
---|
Placebo | -1.10 |
DVS SR 50 mg | -1.25 |
DVS SR 100 mg | -1.44 |
Duloxetine 60 mg | -1.41 |
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Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation
COVI anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, to 5 = Very much. Worst value is 15 and best value is 3. (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | Units on a Scale (Mean) |
---|
| Baseline | Change at Week 8 or FOT |
---|
Duloxetine 60 mg | 6.30 | -1.47 |
,DVS SR 100 mg | 6.30 | -1.35 |
,DVS SR 50 mg | 6.30 | -1.15 |
,Placebo | 6.50 | -1.02 |
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Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation
HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe). (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | Units on a Scale (Mean) |
---|
| Baseline | Change at Week 8 or FOT |
---|
Duloxetine 60 mg | 12.90 | -5.91 |
,DVS SR 100 mg | 12.90 | -6.15 |
,DVS SR 50 mg | 12.80 | -5.41 |
,Placebo | 13.00 | -4.82 |
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Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation
MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | Units on a Scale (Mean) |
---|
| Baseline | Change at Week 8 or FOT |
---|
Duloxetine 60 mg | 30.80 | -14.40 |
,DVS SR 100 mg | 30.70 | -14.40 |
,DVS SR 50 mg | 30.10 | -12.70 |
,Placebo | 31.10 | -11.00 |
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Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation
HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | Units on a Scale (Mean) |
---|
| Baseline | Change at Week 8 or FOT |
---|
Duloxetine 60 mg | 8.38 | -3.80 |
,DVS SR 100 mg | 8.51 | -3.92 |
,DVS SR 50 mg | 8.43 | -3.66 |
,Placebo | 8.38 | -3.13 |
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Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation
Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help. (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | Units on a Scale (Mean) |
---|
| Baseline | Change at Week 8 or FOT |
---|
Duloxetine 60 mg | 3.50 | -1.26 |
,DVS SR 100 mg | 3.70 | -1.54 |
,DVS SR 50 mg | 3.53 | -1.39 |
,Placebo | 3.49 | -1.27 |
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Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation
VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI. (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | mm (Mean) |
---|
| Overall pain (Baseline) | Stomach pain (Baseline) | Back pain (Baseline) | Chest pain (Baseline) | Arms, legs or joint pain (Baseline) | Overall pain (Change at Week 8 or FOT) | Stomach pain (Change at Week 8 or FOT) | Back pain (Change at Week 8 or FOT) | Chest pain (Change at Week 8 or FOT) | Arms, legs or joint pain (Change at Week 8 or FOT) |
---|
Duloxetine 60 mg | 26.10 | 14.00 | 25.50 | 6.60 | 22.40 | -8.84 | -4.38 | -9.33 | -1.67 | -8.35 |
,DVS SR 100 mg | 25.90 | 17.00 | 28.30 | 10.40 | 28.70 | -10.30 | -6.42 | -12.80 | -3.90 | -11.90 |
,DVS SR 50 mg | 30.80 | 19.40 | 32.90 | 10.90 | 29.10 | -9.08 | -4.98 | -10.70 | -3.34 | -8.98 |
,Placebo | 26.30 | 16.70 | 25.90 | 9.40 | 25.80 | -5.61 | -1.86 | -7.04 | -1.95 | -6.99 |
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Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. (NCT00401245)
Timeframe: Baseline up to Week 2
Intervention | Percentage of participants (Number) |
---|
DVS 25 mg, Then 100 mg | 4.0 |
DVS 25/50 mg, Then 100 mg | 9.1 |
DVS 50 mg, Then 100 mg | 6.5 |
DVS 100 mg, Then 100 mg | 14.8 |
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DESS Total Score at 1 Week After the End of Tapering
"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms." (NCT00401245)
Timeframe: Week 19
Intervention | Units on a scale (Mean) |
---|
DVS 50 mg QOD | 3.22 |
DVS 50/25 mg | 4.11 |
DVS 50 mg/Placebo | 1.70 |
Placebo | 1.78 |
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DESS Total Score at End of Second Week of Tapering
"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms." (NCT00401245)
Timeframe: Week 18
Intervention | Units on a scale (Mean) |
---|
DVS 50 mg QOD | 1.19 |
DVS 50/25 mg | 2.44 |
DVS 50 mg/Placebo | 4.46 |
Placebo | 2.44 |
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Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering
"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms." (NCT00401245)
Timeframe: Week 17
Intervention | Units on a scale (Mean) |
---|
DVS 50 mg QOD | 2.26 |
DVS 50/25 mg | 2.28 |
DVS 50 mg/Placebo | 1.84 |
Placebo | 7.07 |
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Mean Age of the Participants in Tapering Phase
Participants were re-randomized to tapering phase after OL phase. (NCT00401245)
Timeframe: Week 17
Intervention | Years (Mean) |
---|
DVS 50 mg QOD | 53.72 |
DVS 50/25 mg | 54.56 |
DVS 50 mg/Placebo | 54.20 |
Placebo | 54.14 |
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Number of Participants With Nausea During the First 2 Weeks of Treatment
Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted. (NCT00401245)
Timeframe: Baseline up to Week 2
Intervention | Participants (Number) |
---|
DVS 25 mg, Then 100 mg | 24 |
DVS 25/50 mg, Then 100 mg | 31 |
DVS 50 mg, Then 100 mg | 28 |
DVS 100 mg, Then 100 mg | 43 |
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Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. (NCT00401245)
Timeframe: Baseline up to Week 2
Intervention | Participants (Number) |
---|
DVS 25 mg, Then 100 mg | 67 |
DVS 25/50 mg, Then 100 mg | 69 |
DVS 50 mg, Then 100 mg | 72 |
DVS 100 mg, Then 100 mg | 80 |
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Number of Participants Showing Satisfaction With Tolerability at the End of Tapering
Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an IVRS/IWRS and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication. (NCT00401245)
Timeframe: Week 19
Intervention | Participants (Number) |
---|
| Extremely dissatisfied | Dissatisfied | Neutral | Satisfied | Extremely satisfied |
---|
DVS 50 mg QOD | 7 | 10 | 10 | 16 | 10 |
,DVS 50 mg/Placebo | 3 | 3 | 5 | 19 | 10 |
,DVS 50/25 mg | 5 | 7 | 5 | 23 | 12 |
,Placebo | 6 | 5 | 7 | 19 | 18 |
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Number of Participants With Each DESS One Week After End of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. (NCT00401245)
Timeframe: Week 19
Intervention | Participants (Number) |
---|
| Agitation | Blurred vision | Bouts of crying or tearfulness | Burning, numbness, tingling sensations | Chills | Confusion or trouble concentrating | Diarrhea | Dizziness, lightheadedness, sensation of spinning | Elevated mood, feeling high | Fatigue, tiredness | Feeling unreal or detached | Fever | Forgetfulness or problems with memory | Headaches | Increased dreaming or nightmares | Increased saliva in mouth | Irritability | Mood swings | Muscle aches or pains | Muscle cramps, spasms, or twitching | Muscle tension or stiffness | Nausea | Nervousness or anxiety | Nose running | Problems with speech or speaking clearly | Restless feeling in legs | Ringing or noises in the ears | Shaking, trembling | Shortness of breath, gasping for air | Sore eyes | Stomach bloating | Stomach cramps | Sudden outbursts of anger | Sudden panic or anxiety attacks | Sudden worsening of mood | Sweating more than usual | Trouble sleeping, insomnia | Uncontrolled mouth/tongue movements | Unsteady gait or incoordination | Unusual sensitivity to sound | Unusual tastes or smells | Unusual visual sensations | Vomiting |
---|
DVS 50 mg QOD | 6 | 2 | 7 | 2 | 3 | 6 | 3 | 13 | 1 | 9 | 6 | 2 | 5 | 4 | 7 | 0 | 11 | 4 | 5 | 5 | 5 | 5 | 9 | 1 | 0 | 1 | 3 | 3 | 1 | 3 | 3 | 2 | 4 | 1 | 7 | 21 | 12 | 0 | 4 | 1 | 1 | 0 | 1 |
,DVS 50 mg/Placebo | 6 | 0 | 2 | 0 | 1 | 4 | 1 | 2 | 0 | 2 | 1 | 0 | 2 | 3 | 0 | 1 | 7 | 6 | 5 | 1 | 3 | 0 | 5 | 3 | 0 | 3 | 0 | 0 | 1 | 1 | 1 | 0 | 3 | 2 | 5 | 4 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
,DVS 50/25 mg | 4 | 0 | 7 | 9 | 3 | 7 | 3 | 17 | 2 | 10 | 5 | 0 | 3 | 11 | 10 | 1 | 9 | 5 | 8 | 5 | 9 | 5 | 10 | 2 | 2 | 6 | 8 | 3 | 1 | 4 | 4 | 3 | 3 | 5 | 4 | 19 | 13 | 1 | 5 | 2 | 3 | 3 | 0 |
,Placebo | 5 | 1 | 3 | 2 | 3 | 2 | 1 | 0 | 0 | 8 | 3 | 0 | 3 | 5 | 3 | 1 | 6 | 4 | 3 | 1 | 2 | 1 | 3 | 1 | 0 | 1 | 0 | 1 | 0 | 2 | 4 | 2 | 5 | 2 | 5 | 12 | 7 | 0 | 1 | 1 | 0 | 1 | 0 |
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Number of Participants With Each DESS at the End of Second Week of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. (NCT00401245)
Timeframe: Week 18
Intervention | Participants (Number) |
---|
| Agitation | Blurred vision | Bouts of crying or tearfulness | Burning, numbness, tingling sensations | Chills | Confusion or trouble concentrating | Diarrhea | Dizziness, lightheadedness, sensation of spinning | Elevated mood, feeling high | Fatigue, tiredness | Feeling unreal or detached | Fever | Forgetfulness or problems with memory | Headaches | Increased dreaming or nightmares | Increased saliva in mouth | Irritability | Mood swings | Muscle aches or pains | Muscle cramps, spasms, or twitching | Muscle tension or stiffness | Nausea | Nervousness or anxiety | Nose running | Problems with speech or speaking clearly | Restless feeling in legs | Ringing or noises in the ears | Shaking, trembling | Shortness of breath, gasping for air | Sore eyes | Stomach bloating | Stomach cramps | Sudden outbursts of anger | Sudden panic or anxiety attacks | Sudden worsening of mood | Sweating more than usual | Trouble sleeping, insomnia | Uncontrolled mouth/tongue movements | Unsteady gait or incoordination | Unusual sensitivity to sound | Unusual tastes or smells | Unusual visual sensations | Vomiting |
---|
DVS 50 mg QOD | 6 | 2 | 2 | 0 | 1 | 0 | 2 | 2 | 3 | 3 | 0 | 0 | 1 | 4 | 4 | 1 | 5 | 3 | 2 | 7 | 1 | 3 | 4 | 1 | 0 | 4 | 1 | 1 | 0 | 2 | 1 | 2 | 4 | 0 | 6 | 19 | 8 | 0 | 0 | 0 | 1 | 0 | 0 |
,DVS 50 mg/Placebo | 10 | 7 | 18 | 3 | 8 | 11 | 5 | 21 | 5 | 14 | 9 | 1 | 4 | 8 | 10 | 2 | 18 | 14 | 9 | 6 | 7 | 15 | 12 | 4 | 4 | 4 | 6 | 3 | 1 | 3 | 6 | 4 | 12 | 5 | 18 | 23 | 22 | 0 | 5 | 3 | 4 | 3 | 5 |
,DVS 50/25 mg | 4 | 6 | 5 | 2 | 3 | 7 | 2 | 12 | 3 | 12 | 5 | 0 | 6 | 5 | 5 | 1 | 10 | 7 | 8 | 3 | 8 | 6 | 6 | 5 | 3 | 4 | 4 | 3 | 2 | 4 | 5 | 3 | 5 | 3 | 5 | 17 | 9 | 1 | 7 | 5 | 1 | 0 | 0 |
,Placebo | 9 | 3 | 6 | 4 | 4 | 4 | 1 | 7 | 3 | 11 | 3 | 1 | 2 | 4 | 8 | 4 | 13 | 5 | 7 | 5 | 7 | 4 | 8 | 7 | 1 | 4 | 2 | 3 | 4 | 5 | 5 | 0 | 8 | 1 | 8 | 23 | 19 | 1 | 3 | 2 | 1 | 2 | 0 |
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Number of Participants With Each DESS at the End of First Week of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. (NCT00401245)
Timeframe: Week 17
Intervention | Participants (Number) |
---|
| Agitation | Blurred vision | Bouts of crying or tearfulness | Burning, numbness, tingling sensations | Chills | Confusion or trouble concentrating | Diarrhea | Dizziness, lightheadedness, sensation of spinning | Elevated mood, feeling high | Fatigue, tiredness | Feeling unreal or detached | Fever | Forgetfulness or problems with memory | Headaches | Increased dreaming or nightmares | Increased saliva in mouth | Irritability | Mood swings | Muscle aches or pains | Muscle cramps, spasms, or twitching | Muscle tension or stiffness | Nausea | Nervousness or anxiety | Nose running | Problems with speech or speaking clearly | Restless feeling in legs | Ringing or noises in the ears | Shaking, trembling | Shortness of breath, gasping for air | Sore eyes | Stomach bloating | Stomach cramps | Sudden outbursts of anger | Sudden panic or anxiety attacks | Sudden worsening of mood | Sweating more than usual | Trouble sleeping, insomnia | Uncontrolled mouth/tongue movements | Unsteady gait or incoordination | Unusual sensitivity to sound | Unusual tastes or smells | Unusual visual sensations | Vomiting |
---|
DVS 50 mg QOD | 1 | 4 | 5 | 5 | 3 | 5 | 7 | 18 | 1 | 9 | 6 | 2 | 6 | 8 | 14 | 0 | 6 | 4 | 5 | 5 | 6 | 14 | 2 | 3 | 3 | 5 | 6 | 4 | 1 | 3 | 5 | 6 | 3 | 0 | 3 | 23 | 13 | 1 | 4 | 1 | 1 | 1 | 4 |
,DVS 50 mg/Placebo | 6 | 2 | 6 | 3 | 3 | 2 | 4 | 9 | 0 | 6 | 1 | 1 | 3 | 9 | 12 | 0 | 6 | 4 | 3 | 2 | 7 | 5 | 7 | 3 | 0 | 0 | 6 | 2 | 1 | 5 | 5 | 0 | 2 | 0 | 4 | 14 | 8 | 0 | 0 | 1 | 1 | 0 | 0 |
,DVS 50/25 mg | 7 | 4 | 3 | 3 | 2 | 4 | 3 | 7 | 0 | 11 | 2 | 0 | 6 | 5 | 13 | 0 | 6 | 5 | 8 | 6 | 6 | 7 | 5 | 3 | 2 | 4 | 2 | 4 | 3 | 3 | 6 | 4 | 4 | 2 | 6 | 19 | 11 | 1 | 1 | 5 | 2 | 0 | 1 |
,Placebo | 18 | 13 | 24 | 9 | 9 | 21 | 20 | 41 | 13 | 24 | 20 | 4 | 12 | 28 | 35 | 4 | 26 | 19 | 19 | 12 | 18 | 28 | 19 | 7 | 6 | 4 | 14 | 11 | 6 | 8 | 19 | 11 | 11 | 9 | 22 | 44 | 37 | 0 | 16 | 7 | 4 | 10 | 11 |
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Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment
Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an interactive voice response system (IVRS)/interactive web based response system (IWRS), and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication. (NCT00401245)
Timeframe: Week 1 and Week 2
Intervention | Participants (Number) |
---|
| Week 1: Extremely dissatisfied (n=124,119,120,111) | Week 1: Dissatisfied (n=124,119,120,111) | Week 1: Neutral (n=124,119,120,111) | Week 1: Satisfied (n=124,119,120,111) | Week 1: Extremely satisfied (n=124,119,120,111) | Week 2: Extremely dissatisfied (n=115,105,113,94) | Week 2: Dissatisfied (n=115,105,113,94) | Week 2: Neutral (n=115,105,113,94) | Week 2: Satisfied (n=115,105,113,94) | Week 2: Extremely satisfied (n=115,105,113,94) |
---|
DVS 100 mg, Then 100 mg | 4 | 16 | 19 | 39 | 33 | 0 | 1 | 15 | 40 | 38 |
,DVS 25 mg, Then 100 mg | 2 | 1 | 20 | 47 | 54 | 2 | 3 | 17 | 43 | 50 |
,DVS 25/50 mg, Then 100 mg | 3 | 6 | 13 | 48 | 49 | 0 | 4 | 17 | 35 | 49 |
,DVS 50 mg, Then 100 mg | 1 | 8 | 28 | 43 | 40 | 0 | 8 | 18 | 41 | 46 |
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Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score
MS-TSQ is a questionnaire assessing participants' degree of satisfaction with regard to the test article which was administered to the participants via an IVRS/IWRS. The questionnaire comprised 8 questions and each was rated on a scale from 0 (extremely dissatisfied) to 4 (extremely satisfied). (NCT00401245)
Timeframe: Week 16
Intervention | Units on a scale (Mean) |
---|
| Ability to control hot flushes during the day | Ability to control hot flushes during the night | Effect on quality of sleep | Effect on mood or emotions | Effect on interest in sex | Effect on ability to concentrate | Tolerability to side effects | Overall satisfaction |
---|
DVS 100 mg | 2.64 | 2.71 | 2.59 | 3.02 | 2.37 | 2.67 | 3.04 | 2.81 |
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Gender of the Participants in Tapering Phase
Participants were re-randomized to tapering phase after OL phase. (NCT00401245)
Timeframe: Week 17
Intervention | Participants (Number) |
---|
| Female | Male |
---|
DVS 50 mg QOD | 101 | 0 |
,DVS 50 mg/Placebo | 87 | 0 |
,DVS 50/25 mg | 94 | 0 |
,Placebo | 102 | 0 |
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Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16
MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life. (NCT00401245)
Timeframe: Baseline, Week 4, Week 8, Week 12 and Week 16
Intervention | Units on a scale (Mean) |
---|
| Baseline | Week 4 (n=385) | Week 8 (n=364) | Week 12 (n=354) | Week 16 (n=277) |
---|
DVS 100 mg | 4.46 | 2.99 | 2.85 | 2.76 | 2.67 |
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Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks
CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse). (NCT00406640)
Timeframe: 8 weeks
Intervention | units on scale (Mean) |
---|
Desvenlafaxine Succinate Sustained-release (DVS SR) | 1.93 |
Escitalopram | 1.81 |
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Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4) with 0=none/absent and 4=most severe,for a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17. (NCT00406640)
Timeframe: Baseline and 8 weeks
Intervention | units on scale (Mean) |
---|
Desvenlafaxine Succinate Sustained-release (DVS SR) | -13.63 |
Escitalopram | -14.30 |
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Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8
EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score. (NCT00406640)
Timeframe: Baseline and week 8
Intervention | units on scale (Mean) |
---|
Desvenlafaxine Succinate Sustained-release (DVS SR) | 0.25 |
Escitalopram | 0.24 |
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Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week
CGI-S is a global rating scale that measures the severity of a patient's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with patients who have the same diagnosis (1= normal; 7= extremely ill). (NCT00406640)
Timeframe: Baseline and 8 weeks
Intervention | units on scale (Mean) |
---|
Desvenlafaxine Succinate Sustained-release (DVS SR) | -2.09 |
Escitalopram | -2.22 |
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Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)
A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 8 weeks
Intervention | percentage of patients (Number) |
---|
Desvenlafaxine Succinate Sustained-release (DVS SR) | 64.3 |
Escitalopram | 73.4 |
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Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase
Patients who did not achieve a response to treatment at the end of the 8-week acute double blind phase entered into an open label (OL) treatment phase with DVS SR for 6 months and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months
Intervention | Percentage of Non-Responders (Number) |
---|
DVS SR Non-Responders / DVS SR OL | 40.6 |
ESC Non-Responders / DVS SR OL | 47.5 |
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Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score
The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A total score minus baseline adjusted mean total score. (NCT00406640)
Timeframe: Baseline and Week 8
Intervention | units on scale (Mean) |
---|
Desvenlafaxine Succinate Sustained-release (DVS SR) | -11.37 |
Escitalopram | -11.73 |
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Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase
Patients who didn't achieve a response to treatment at the end of the 8-week acute double blind phase entered into an OL treatment phase with DVS SR for 6 months and were evaluated to see if a response was achieved. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months
Intervention | Percentage of Non-Responders (Number) |
---|
DVS SR Non-Responders / DVS SR OL | 39.1 |
ESC Non-Responders / DVS SR OL | 50.8 |
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Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)
Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 8 weeks
Intervention | Percentage of patients (Number) |
---|
Desvenlafaxine Succinate Sustained-release (DVS SR) | 37.9 |
Escitalopram | 48.1 |
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Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)
Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months
Intervention | percentage of responders (Number) |
---|
DVS SR Responders / DVS SR DB | 67.9 |
ESC Responders / ESC DB | 61.3 |
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Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase
Patients achieving a response to treatment (Responders) at the end of the 8-week acute double blind (DB) phase continued into a 6-month DB phase. Responders without remission at 8 weeks were assessed for remission status during the 6-month continuation. Remission defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale assessing 17 items characteristically associated with major depression. Individual items scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months
Intervention | percentage of responders (Number) |
---|
DVS SR Responders / DVS SR DB | 88.9 |
ESC Responders / ESC DB | 81.8 |
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Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)
Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if the response was maintained. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months
Intervention | percentage of responders (Number) |
---|
DVS SR Responders / DVS SR DB | 81.8 |
ESC Responders / ESC DB | 80.0 |
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Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
DESS is a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms. The DESS score was assessed by status of taper. (NCT00406640)
Timeframe: 6 months
Intervention | units on scale (Mean) |
---|
| End of Therapy | Taper week 1 | Taper week 2 | Post-taper |
---|
Desvenlafaxine Succinate Sustained-Release (DVS SR) | 1.49 | 1.18 | 2.29 | 1.61 |
,Escitalopram (ESC) | 1.52 | 1.68 | 3.16 | 1.48 |
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Area Under the Curve From Time Zero to Infinity (AUC0-∞)
AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to infinity. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL). (NCT00619619)
Timeframe: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
Intervention | ng*hr/mL (Mean) |
---|
Desvenlafaxine 10 mg Children | 628 |
Desvenlafaxine 25 mg Children | 1704 |
Desvenlafaxine 50 mg Children | 2414 |
Desvenlafaxine 100 mg Children | 6732 |
Desvenlafaxine 25 mg Adolescent | 1123 |
Desvenlafaxine 50 mg Adolescent | 2281 |
Desvenlafaxine 100 mg Adolescent | 5290 |
Desvenlafaxine 200 mg Adolescent | 11730 |
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr). (NCT00619619)
Timeframe: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
Intervention | hr (Mean) |
---|
Desvenlafaxine 10 mg Children | 4.7 |
Desvenlafaxine 25 mg Children | 4.3 |
Desvenlafaxine 50 mg Children | 5.1 |
Desvenlafaxine 100 mg Children | 5.0 |
Desvenlafaxine 25 mg Adolescent | 4.3 |
Desvenlafaxine 50 mg Adolescent | 8.7 |
Desvenlafaxine 100 mg Adolescent | 7.6 |
Desvenlafaxine 200 mg Adolescent | 7.5 |
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Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr). (NCT00619619)
Timeframe: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
Intervention | hr (Mean) |
---|
Desvenlafaxine 10 mg Children | 7.8 |
Desvenlafaxine 25 mg Children | 8.6 |
Desvenlafaxine 50 mg Children | 9.4 |
Desvenlafaxine 100 mg Children | 9.0 |
Desvenlafaxine 25 mg Adolescent | 12 |
Desvenlafaxine 50 mg Adolescent | 10.2 |
Desvenlafaxine 100 mg Adolescent | 9.6 |
Desvenlafaxine 200 mg Adolescent | 9.8 |
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Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. (NCT00619619)
Timeframe: Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)
Intervention | percentage of participants (Number) |
---|
| Inpatient Days 1 to 4: not ill at all | Inpatient Days 1 to 4: borderline ill | Inpatient Days 1 to 4: mildly ill | Inpatient Days 1 to 4: moderately ill | Inpatient Days 1 to 4: markedly ill | Outpatient Days 5 to 7: not ill at all | Outpatient Days 5 to 7: borderline ill | Outpatient Days 5 to 7: mildly ill | Outpatient Days 5 to 7: moderately ill | Outpatient Days 5 to 7: markedly ill | Outpatient Week 2: not ill at all | Outpatient Week 2: borderline ill | Outpatient Week 2: mildly ill | Outpatient Week 2: moderately ill | Outpatient Week 2: markedly ill | Outpatient Week 3: not ill at all | Outpatient Week 3: borderline ill | Outpatient Week 3: mildly ill | Outpatient Week 3: moderately ill | Outpatient Week 3: markedly ill | Outpatient Week 4: not ill at all | Outpatient Week 4: borderline ill | Outpatient Week 4: mildly ill | Outpatient Week 4: moderately ill | Outpatient Week 4: markedly ill | Outpatient Week 5: not ill at all | Outpatient Week 5: borderline ill | Outpatient Week 5: mildly ill | Outpatient Week 5: moderately ill | Outpatient Week 5: markedly ill | Outpatient Week 6: not ill at all | Outpatient Week 6: borderline ill | Outpatient Week 6: mildly ill | Outpatient Week 6: moderately ill | Outpatient Week 6: markedly ill | Outpatient Week 7: not ill at all | Outpatient Week 7: borderline ill | Outpatient Week 7: mildly ill | Outpatient Week 7: moderately ill | Outpatient Week 7: markedly ill | Outpatient Week 8: not ill at all | Outpatient Week 8: borderline ill | Outpatient Week 8: mildly ill | Outpatient Week 8: moderately ill | Outpatient Week 8: markedly ill | Outpatient Week >8: not ill at all | Outpatient Week >8: borderline ill | Outpatient Week >8: mildly ill | Outpatient Week >8: moderately ill | Outpatient Week >8: markedly ill |
---|
Desvenlafaxine 10 mg Children | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 0.0 | 66.7 | 33.3 | 0.0 | 0.0 | 0.0 | 66.7 | 33.3 | 0.0 | 0.0 | 16.7 | 66.7 | 16.7 | 0.0 | 0.0 | 16.7 | 66.7 | 16.7 | 0.0 | 0.0 | 50 | 50 | 0.0 | 0.0 | 0.0 | 50 | 50 | 0.0 | 0.0 | 0.0 | 66.7 | 33.3 | 0.0 | 0.0 | 0.0 | 66.7 | 33.3 | 0.0 | 0.0 |
,Desvenlafaxine 100 mg Adolescent | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 0.0 | 50 | 50 | 0.0 | 0.0 | 25 | 37.5 | 37.5 | 0.0 | 0.0 | 50 | 12.5 | 37.5 | 0.0 | 0.0 | 50 | 12.5 | 37.5 | 0.0 | 0.0 | 62.5 | 12.5 | 25 | 0.0 | 0.0 | 62.5 | 25 | 12.5 | 0.0 | 12.5 | 50 | 25 | 12.5 | 0.0 | 12.5 | 50 | 25 | 12.5 | 0.0 |
,Desvenlafaxine 100 mg Children | 0.0 | 0.0 | 14.3 | 85.7 | 0.0 | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 0.0 | 14.3 | 85.7 | 0.0 | 0.0 | 0.0 | 14.3 | 85.7 | 0.0 | 0.0 | 0.0 | 28.6 | 71.4 | 0.0 | 0.0 | 0.0 | 28.6 | 71.4 | 0.0 | 0.0 | 0.0 | 71.4 | 28.6 | 0.0 | 0.0 | 0.0 | 71.4 | 28.6 | 0.0 |
,Desvenlafaxine 200 mg Adolescent | 0.0 | 0.0 | 12.5 | 87.5 | 0.0 | 0.0 | 0.0 | 12.5 | 87.5 | 0.0 | 0.0 | 0.0 | 12.5 | 87.5 | 0.0 | 0.0 | 0.0 | 12.5 | 87.5 | 0.0 | 0.0 | 0.0 | 37.5 | 62.5 | 0.0 | 0.0 | 0.0 | 37.5 | 62.5 | 0.0 | 0.0 | 0.0 | 50 | 50 | 0.0 | 0.0 | 0.0 | 50 | 50 | 0.0 | 0.0 | 0.0 | 62.5 | 37.5 | 0.0 | 0.0 | 0.0 | 62.5 | 37.5 | 0.0 |
,Desvenlafaxine 25 mg Adolescent | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 0.0 | 28.6 | 71.4 | 0.0 | 0.0 | 0.0 | 28.6 | 71.4 | 0.0 | 0.0 | 0.0 | 28.6 | 71.4 | 0.0 | 0.0 | 0.0 | 57.1 | 42.9 | 0.0 | 0.0 | 0.0 | 57.1 | 42.9 | 0.0 | 0.0 | 0.0 | 57.1 | 42.9 | 0.0 | 0.0 | 0.0 | 57.1 | 42.9 | 0.0 |
,Desvenlafaxine 25 mg Children | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 0.0 | 42.9 | 57.1 | 0.0 | 0.0 | 14.3 | 57.1 | 28.6 | 0.0 | 0.0 | 57.1 | 42.9 | 0.0 | 0.0 | 14.3 | 57.1 | 28.6 | 0.0 | 0.0 | 14.3 | 57.1 | 28.6 | 0.0 | 0.0 | 0.0 | 57.1 | 42.9 | 0.0 | 0.0 | 0.0 | 42.9 | 57.1 | 0.0 | 0.0 | 0.0 | 42.9 | 57.1 | 0.0 | 0.0 | 0.0 | 57.1 | 42.9 | 0.0 | 0.0 |
,Desvenlafaxine 50 mg Adolescent | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 0.0 | 14.3 | 85.7 | 0.0 | 0.0 | 0.0 | 28.6 | 71.4 | 0.0 | 0.0 | 0.0 | 57.1 | 42.9 | 0.0 | 0.0 | 0.0 | 85.7 | 14.3 | 0.0 | 0.0 | 0.0 | 85.7 | 14.3 | 0.0 | 0.0 | 14.3 | 57.1 | 28.6 | 0.0 | 0.0 | 14.3 | 57.1 | 28.6 | 0.0 | 0.0 | 28.6 | 71.4 | 0.0 | 0.0 | 0.0 | 28.6 | 71.4 | 0.0 | 0.0 |
,Desvenlafaxine 50 mg Children | 0.0 | 0.0 | 0.0 | 88.9 | 11.1 | 0.0 | 0.0 | 44.4 | 55.6 | 0.0 | 0.0 | 11.1 | 55.6 | 33.3 | 0.0 | 0.0 | 0.0 | 88.9 | 11.1 | 0.0 | 0.0 | 11.1 | 66.7 | 22.2 | 0.0 | 11.1 | 11.1 | 55.6 | 22.2 | 0.0 | 11.1 | 11.1 | 66.7 | 11.1 | 0.0 | 11.1 | 11.1 | 77.8 | 0.0 | 0.0 | 11.1 | 22.2 | 66.7 | 0.0 | 0.0 | 11.1 | 33.3 | 55.6 | 0.0 | 0.0 |
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Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)
AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect. (NCT00619619)
Timeframe: Baseline to Follow-up (up to Day 77)
Intervention | participants (Number) |
---|
| Serious Adverse Events | Non-serious Adverse Events |
---|
Desvenlafaxine 10 mg Children | 0 | 1 |
,Desvenlafaxine 100 mg Adolescent | 0 | 7 |
,Desvenlafaxine 100 mg Children | 0 | 7 |
,Desvenlafaxine 200 mg Adolescent | 0 | 8 |
,Desvenlafaxine 25 mg Adolescent | 1 | 4 |
,Desvenlafaxine 25 mg Children | 0 | 3 |
,Desvenlafaxine 50 mg Adolescent | 0 | 2 |
,Desvenlafaxine 50 mg Children | 0 | 3 |
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Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline. (NCT00619619)
Timeframe: Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)
Intervention | percentage of participants (Number) |
---|
| Inpatient Days 1 to 4: very much improved | Inpatient Days 1 to 4: much improved | Inpatient Days 1 to 4: minimally improved | Inpatient Days 1 to 4: no change | Inpatient Days 1 to 4: minimally worse | Outpatient Days 5 to 7: very much improved | Outpatient Days 5 to 7: much improved | Outpatient Days 5 to 7: minimally improved | Outpatient Days 5 to 7: no change | Outpatient Days 5 to 7: minimally worse | Outpatient Week 2: very much improved | Outpatient Week 2: much improved | Outpatient Week 2: minimally improved | Outpatient Week 2: no change | Outpatient Week 2: minimally worse | Outpatient Week 3: very much improved | Outpatient Week 3: much improved | Outpatient Week 3: minimally improved | Outpatient Week 3: no change | Outpatient Week 3: minimally worse | Outpatient Week 4: very much improved | Outpatient Week 4: much improved | Outpatient Week 4: minimally improved | Outpatient Week 4: no change | Outpatient Week 4: minimally worse | Outpatient Week 5: very much improved | Outpatient Week 5: much improved | Outpatient Week 5: minimally improved | Outpatient Week 5: no change | Outpatient Week 5: minimally worse | Outpatient Week 6: very much improved | Outpatient Week 6: much improved | Outpatient Week 6: minimally improved | Outpatient Week 6: no change | Outpatient Week 6: minimally worse | Outpatient Week 7: very much improved | Outpatient Week 7: much improved | Outpatient Week 7: minimally improved | Outpatient Week 7: no change | Outpatient Week 7: minimally worse | Outpatient Week 8: very much improved | Outpatient Week 8: much improved | Outpatient Week 8: minimally improved | Outpatient Week 8: no change | Outpatient Week 8: minimally worse | Outpatient Week >8: very much improved | Outpatient Week >8: much improved | Outpatient Week >8: minimally improved | Outpatient Week >8: no change | Outpatient Week >8: minimally worse |
---|
Desvenlafaxine 10 mg Children | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 0.0 | 50 | 50 | 0.0 | 0.0 | 33.3 | 50 | 16.7 | 0.0 | 0.0 | 50 | 50 | 0.0 | 0.0 | 0.0 | 50 | 50 | 0.0 | 0.0 | 0.0 | 50 | 50 | 0.0 | 0.0 | 0.0 | 50 | 50 | 0.0 | 0.0 | 0.0 | 50 | 50 | 0.0 | 0.0 | 0.0 | 83.3 | 16.7 | 0.0 | 0.0 | 0.0 | 83.3 | 16.7 | 0.0 | 0.0 |
,Desvenlafaxine 100 mg Adolescent | 0.0 | 0.0 | 12.5 | 87.5 | 0.0 | 0.0 | 0.0 | 25 | 75 | 0.0 | 0.0 | 0.0 | 75 | 25 | 0.0 | 0.0 | 37.5 | 37.5 | 25 | 0.0 | 0.0 | 50 | 37.5 | 12.5 | 0.0 | 0.0 | 50 | 37.5 | 12.5 | 0.0 | 0.0 | 75 | 12.5 | 12.5 | 0.0 | 0.0 | 75 | 12.5 | 12.5 | 0.0 | 12.5 | 75 | 0.0 | 12.5 | 0.0 | 12.5 | 75 | 0.0 | 12.5 | 0.0 |
,Desvenlafaxine 100 mg Children | 0.0 | 14.3 | 0.0 | 85.7 | 0.0 | 0.0 | 0.0 | 42.9 | 57.1 | 0.0 | 0.0 | 14.3 | 42.9 | 42.9 | 0.0 | 0.0 | 14.3 | 57.1 | 28.6 | 0.0 | 0.0 | 28.6 | 57.1 | 14.3 | 0.0 | 0.0 | 28.6 | 71.4 | 0.0 | 0.0 | 0.0 | 28.6 | 71.4 | 0.0 | 0.0 | 0.0 | 28.6 | 71.4 | 0.0 | 0.0 | 0.0 | 71.4 | 28.6 | 0.0 | 0.0 | 0.0 | 71.4 | 28.6 | 0.0 | 0.0 |
,Desvenlafaxine 200 mg Adolescent | 0.0 | 12.5 | 37.5 | 50 | 0.0 | 0.0 | 12.5 | 25 | 62.5 | 0.0 | 0.0 | 25 | 50 | 25 | 0.0 | 0.0 | 25 | 62.5 | 12.5 | 0.0 | 0.0 | 37.5 | 37.5 | 12.5 | 12.5 | 0.0 | 37.5 | 37.5 | 12.5 | 12.5 | 0.0 | 50 | 25 | 25 | 0.0 | 0.0 | 50 | 37.5 | 12.5 | 0.0 | 0.0 | 62.5 | 37.5 | 0.0 | 0.0 | 0.0 | 62.5 | 37.5 | 0.0 | 0.0 |
,Desvenlafaxine 25 mg Adolescent | 0.0 | 14.3 | 0.00 | 85.7 | 0.0 | 0.0 | 0.0 | 42.9 | 57.1 | 0.0 | 0.0 | 0.0 | 42.9 | 57.1 | 0.0 | 0.0 | 28.6 | 57.1 | 14.3 | 0.0 | 0.0 | 28.6 | 57.1 | 14.3 | 0.0 | 0.0 | 28.6 | 57.1 | 14.3 | 0.0 | 0.0 | 57.1 | 28.6 | 14.3 | 0.0 | 0.0 | 57.1 | 28.6 | 14.3 | 0.0 | 0.0 | 57.1 | 28.6 | 14.3 | 0.0 | 0.0 | 57.1 | 28.6 | 14.3 | 0.0 |
,Desvenlafaxine 25 mg Children | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 14.3 | 14.3 | 71.4 | 0.0 | 0.0 | 28.6 | 42.9 | 28.6 | 0.0 | 0.0 | 85.7 | 14.3 | 0.0 | 0.0 | 14.3 | 71.4 | 14.3 | 0.0 | 0.0 | 14.3 | 85.7 | 0.0 | 0.0 | 0.0 | 14.3 | 57.1 | 28.6 | 0.0 | 0.0 | 14.3 | 42.9 | 42.9 | 0.0 | 0.0 | 14.3 | 71.4 | 14.3 | 0.0 | 0.0 | 14.3 | 71.4 | 14.3 | 0.0 | 0.0 |
,Desvenlafaxine 50 mg Adolescent | 0.0 | 0.0 | 0.0 | 100 | 0.0 | 0.0 | 0.0 | 57.1 | 42.9 | 0.0 | 0.0 | 0.0 | 57.1 | 42.9 | 0.0 | 0.0 | 0.0 | 71.4 | 28.6 | 0.0 | 0.0 | 0.0 | 85.7 | 14.3 | 0.0 | 0.0 | 0.0 | 85.7 | 14.3 | 0.0 | 0.0 | 71.4 | 28.6 | 0.0 | 0.0 | 0.0 | 71.4 | 28.6 | 0.0 | 0.0 | 0.0 | 71.4 | 28.6 | 0.0 | 0.0 | 0.0 | 71.4 | 28.6 | 0.0 | 0.0 |
,Desvenlafaxine 50 mg Children | 0.0 | 0.0 | 11.1 | 88.9 | 0.0 | 0.0 | 11.1 | 55.6 | 33.3 | 0.0 | 11.1 | 44.4 | 11.1 | 33.3 | 0.0 | 0.0 | 44.4 | 44.4 | 11.1 | 0.0 | 0.0 | 55.6 | 22.2 | 11.1 | 11.1 | 11.1 | 55.6 | 22.2 | 0.0 | 11.1 | 11.1 | 66.7 | 22.2 | 0.0 | 0.0 | 11.1 | 55.6 | 33.3 | 0.0 | 0.0 | 22.2 | 22.2 | 55.6 | 0.0 | 0.0 | 22.2 | 33.3 | 44.4 | 0.0 | 0.0 |
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Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score
HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states. (NCT00619619)
Timeframe: Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)
Intervention | Score on a scale (Mean) |
---|
| Inpatient Days 1 to 4 | Outpatient Days 5 to 7 | Outpatient Week 2 | Outpatient Week 3 | Outpatient Week 4 | Outpatient Week 5 | Outpatient Week 8 | Outpatient Week >8 |
---|
Desvenlafaxine 10 mg Children | -6.00 | -6.00 | -9.33 | -9.33 | -11.00 | -11.00 | -12.17 | -12.17 |
,Desvenlafaxine 100 mg Adolescent | -1.50 | -1.50 | -8.13 | -8.13 | -12.13 | -12.25 | -14.25 | -13.00 |
,Desvenlafaxine 100 mg Children | -2.43 | -2.43 | -5.57 | -5.57 | -7.57 | -9.00 | -11.14 | -11.14 |
,Desvenlafaxine 200 mg Adolescent | -5.63 | -5.63 | -9.38 | -8.88 | -9.00 | -9.00 | -11.63 | -11.63 |
,Desvenlafaxine 25 mg Adolescent | -2.29 | -2.00 | -2.71 | -2.71 | -7.29 | -7.29 | -11.14 | -11.14 |
,Desvenlafaxine 25 mg Children | -5.43 | -5.43 | -10.71 | -10.29 | -13.00 | -14.14 | -14.00 | -13.86 |
,Desvenlafaxine 50 mg Adolescent | -0.57 | -0.57 | -5.71 | -5.71 | -7.57 | -7.57 | -9.86 | -9.86 |
,Desvenlafaxine 50 mg Children | -0.33 | -0.33 | -6.11 | -6.11 | -7.22 | -7.56 | -8.44 | -9.11 |
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Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score
CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms. (NCT00619619)
Timeframe: Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)
Intervention | scores on a scale (Mean) |
---|
| Inpatient Days 1 to 4 | Outpatient Days 5 to 7 | Outpatient Week 2 | Outpatient Week 3 | Outpatient Week 4 | Outpatient Week 5 | Outpatient Week 6 | Outpatient Week 7 | Outpatient Week 8 | Outpatient Week >8 |
---|
Desvenlafaxine 10 mg Children | -6.83 | -10.67 | -17.67 | -19.67 | -19.50 | -19.50 | -21.83 | -21.83 | -22.00 | -22.00 |
,Desvenlafaxine 100 mg Adolescent | -8.25 | -9.50 | -18.13 | -21.25 | -23.50 | -23.88 | -24.63 | -25.38 | -27.25 | -26.75 |
,Desvenlafaxine 100 mg Children | -6.43 | -7.86 | -9.57 | -10.43 | -10.00 | -10.29 | -12.00 | -12.00 | -14.14 | -14.14 |
,Desvenlafaxine 200 mg Adolescent | -10.38 | -11.25 | -13.13 | -13.13 | -12.50 | -12.50 | -14.38 | -14.50 | -15.38 | -15.38 |
,Desvenlafaxine 25 mg Adolescent | -7.00 | -8.00 | -8.29 | -11.71 | -14.57 | -14.57 | -20.57 | -20.57 | -21.43 | -21.43 |
,Desvenlafaxine 25 mg Children | -9.86 | -13.86 | -18.86 | -18.57 | -20.86 | -23.00 | -19.86 | -20.43 | -20.29 | -20.00 |
,Desvenlafaxine 50 mg Adolescent | -4.57 | -8.29 | -11.29 | -14.57 | -19.43 | -19.43 | -17.14 | -17.14 | -22.29 | -22.29 |
,Desvenlafaxine 50 mg Children | -2.78 | -10.44 | -14.44 | -16.89 | -17.56 | -19.56 | -18.44 | -19.11 | -19.78 | -19.89 |
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Maximum Observed Plasma Concentration (Cmax)
Noncompartmental pharmacokinetic (PK) parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms per milliliter (ng/mL). (NCT00619619)
Timeframe: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
Intervention | ng/mL (Mean) |
---|
Desvenlafaxine 10 mg Children | 33.9 |
Desvenlafaxine 25 mg Children | 98 |
Desvenlafaxine 50 mg Children | 108 |
Desvenlafaxine 100 mg Children | 263 |
Desvenlafaxine 25 mg Adolescent | 46.1 |
Desvenlafaxine 50 mg Adolescent | 93.9 |
Desvenlafaxine 100 mg Adolescent | 202 |
Desvenlafaxine 200 mg Adolescent | 449 |
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Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. (NCT00669110)
Timeframe: Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
Intervention | percentage of participants (Number) |
---|
| Outpatient Week 1: not ill at all | Outpatient Week 1: borderline ill | Outpatient Week 1: mildly ill | Outpatient Week 1: moderately ill | Outpatient Week 2: not ill at all | Outpatient Week 2: borderline ill | Outpatient Week 2: mildly ill | Outpatient Week 2: moderately ill | Outpatient Week 4: not ill at all | Outpatient Week 4: borderline ill | Outpatient Week 4: mildly ill | Outpatient Week 4: moderately ill | Outpatient Week 6: not ill at all | Outpatient Week 6: borderline ill | Outpatient Week 6: mildly ill | Outpatient Week 6: moderately ill | Outpatient Week 10: not ill at all | Outpatient Week 10: borderline ill | Outpatient Week 10: mildly ill | Outpatient Week 10: moderately ill | Outpatient Week 14: not ill at all | Outpatient Week 14: borderline ill | Outpatient Week 14: mildly ill | Outpatient Week 14: moderately ill | Outpatient Week 18: not ill at all | Outpatient Week 18: borderline ill | Outpatient Week 18: mildly ill | Outpatient Week 18: moderately ill | Outpatient Week 22: not ill at all | Outpatient Week 22: borderline ill | Outpatient Week 22: mildly ill | Outpatient Week 22: moderately ill | Outpatient Week 26: not ill at all | Outpatient Week 26: borderline ill | Outpatient Week 26: mildly ill | Outpatient Week 26: moderately ill | Outpatient Week >26: not ill at all | Outpatient Week >26: borderline ill | Outpatient Week >26: mildly ill | Outpatient Week >26: moderately ill |
---|
DVS SR - Adolescents | 10.5 | 10.5 | 57.9 | 21.1 | 10 | 20 | 45 | 25 | 10 | 30 | 35 | 25 | 10 | 20 | 50 | 20 | 10 | 35 | 45 | 10 | 5 | 55 | 30 | 10 | 5 | 55 | 35 | 5 | 5 | 55 | 35 | 5 | 5 | 50 | 40 | 5 | 5 | 50 | 40 | 5 |
,DVS SR - Children | 13.3 | 53.3 | 26.7 | 6.7 | 10 | 40 | 45 | 5 | 10 | 50 | 30 | 10 | 10 | 40 | 45 | 5 | 15 | 45 | 35 | 5 | 5 | 55 | 35 | 5 | 5 | 70 | 20 | 5 | 5 | 60 | 30 | 5 | 5 | 75 | 15 | 5 | 5 | 75 | 15 | 5 |
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Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline. (NCT00669110)
Timeframe: Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
Intervention | percentage of participants (Number) |
---|
| Outpatient Week 1: very much improved | Outpatient Week 1: much improved | Outpatient Week 1: minimally improved | Outpatient Week 1: minimally worse | Outpatient Week 2: very much improved | Outpatient Week 2: much improved | Outpatient Week 2: minimally improved | Outpatient Week 4: very much improved | Outpatient Week 4: much improved | Outpatient Week 4: minimally improved | Outpatient Week 4: minimally worse | Outpatient Week 6: very much improved | Outpatient Week 6: much improved | Outpatient Week 6: minimally improved | Outpatient Week 10: very much improved | Outpatient Week 10: much improved | Outpatient Week 10: minimally improved | Outpatient Week 10: no change | Outpatient Week 14: very much improved | Outpatient Week 14: much improved | Outpatient Week 14: minimally improved | Outpatient Week 14: no change | Outpatient Week 18: very much improved | Outpatient Week 18: much improved | Outpatient Week 18: minimally improved | Outpatient Week 22: very much improved | Outpatient Week 22: much improved | Outpatient Week 22: minimally improved | Outpatient Week 26: very much improved | Outpatient Week 26: much improved | Outpatient Week 26: minimally improved | Outpatient Week >26: very much improved | Outpatient Week >26: much improved | Outpatient Week >26: minimally improved |
---|
DVS SR - Adolescents | 10 | 45 | 40 | 5 | 15 | 55 | 30 | 20 | 55 | 25 | 0.0 | 20 | 65 | 15 | 30 | 50 | 15 | 5 | 40 | 40 | 15 | 5 | 40 | 45 | 15 | 45 | 40 | 15 | 40 | 45 | 15 | 40 | 45 | 15 |
,DVS SR - Children | 25 | 55 | 20 | 0.0 | 25 | 55 | 15 | 35 | 45 | 15 | 5 | 35 | 35 | 30 | 30 | 40 | 30 | 0.0 | 25 | 50 | 20 | 5 | 30 | 55 | 15 | 30 | 50 | 20 | 40 | 45 | 15 | 40 | 45 | 15 |
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Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Weight
Vitals signs meeting the PCI criteria for weight categorized according to an increase of ≥7 percent or a decrease of ≥3.5 percent in body weight. (NCT00669110)
Timeframe: Baseline (Extension study) up to Week 26 (Extension study)
Intervention | participants (Number) |
---|
| Increase ≥7 percent in body weight | Decrease of ≥3.5 percent in body weight |
---|
DVS SR - Adolescents | 4 | 3 |
,DVS SR - Children | 11 | 1 |
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Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate
PCI criteria for females: supine pulse rate (beats per minute [bpm]) ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <63 or >121 at age 12 to <54 or >110 at age 17; pulse from <50 or >104 at age 18. Criteria for males: pulse ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <58 or >116 at age 12 to <50 or >104 at age 17; pulse from <45 or >99 at age 18. Vitals signs meeting criteria for PCI categorized as Low or as postural change in pulse (increase in pulse ≥20 bpm for last supine to first standing pulse [supine to standing]). (NCT00669110)
Timeframe: Baseline (Extension study) up to Week 26 (Extension study)
Intervention | participants (Number) |
---|
| Low supine pulse rate | Increase in pulse rate ≥20 mmHg supine to standing |
---|
DVS SR - Adolescents | 2 | 12 |
,DVS SR - Children | 1 | 14 |
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Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP)
PCI criteria for females: systolic BP [SBP] ranges from >110 and diastolic BP [DBP] >73 (>110/73) at age 6 up to BP >124/81 at age 11; BP from >121/79 at age 12 up to BP >132/86 at age 17. Criteria for males: BP ranges from >112/73 at age 6 up to BP >123/82 at age 10; BP from >119/79 at age 11 up to BP >140/89 at age 17. Vitals signs meeting the criteria for PCI categorized as BP elevation for 3 consecutive visits or as postural change in BP (decrease in SBP ≥20 millimeters of mercury [mmHg] or in DBP ≥15 mmHg for the last supine to first standing BP [supine to standing]). (NCT00669110)
Timeframe: Baseline (Extension study) up to Week 26 (Extension study)
Intervention | participants (Number) |
---|
| Elevated supine SBP, 3 consecutive visits | Decrease SBP ≥20 mmHg supine to standing | Decrease DBP ≥15 mmHg supine to standing |
---|
DVS SR - Adolescents | 0 | 0 | 3 |
,DVS SR - Children | 4 | 2 | 0 |
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Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)
Laboratory test results meeting the criteria for PCI categorized as bicarbonate increase or decrease from baseline of ≥4 millimoles per liter (mmol/L); hematocrit <0.32 or >0.50 (females) or <0.37 or >0.55 (males) liters per liter (L/L); high density lipoprotein (HDL) cholesterol (fasting or nonfasting / unknown) decrease >0.21 mmol/L and test value ≥1.16 mmol/L; triglycerides (fasting or nonfasting / unknown) ≥2.258 mmol/L or increase ≥1.13 mmol/L and test value ≥3.39 mmol/L; urine specific gravity <1.001 or >1.035; and positive urinalysis result for protein (albumin), hemoglobin, or ketones. (NCT00669110)
Timeframe: Baseline (Extension study) up to Week 26 (Extension study)
Intervention | participants (Number) |
---|
| Bicarbonate: increase | Bicarbonate: decrease | Hematocrit: low | HDL cholesterol: decrease | Triglycerides: high | Urine specific gravity: high | Urine protein albumin: positive result | Urine ketones: positive result | Urine hemoglobin: positive result |
---|
DVS SR - Adolescents | 0 | 1 | 2 | 1 | 1 | 3 | 9 | 1 | 1 |
,DVS SR - Children | 2 | 0 | 4 | 2 | 4 | 3 | 9 | 0 | 0 |
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Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
HAM-D17 is a clinician-rated interview to measure presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states. (NCT00669110)
Timeframe: Baseline (Extension study), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
Intervention | scores on a scale (Mean) |
---|
| Baseline mean | Change from Bsl Outpatient Week 1 | Change from Bsl Outpatient Week 2 | Change from Bsl Outpatient Week 4 | Change from Bsl Outpatient Week 6 | Change from Bsl Outpatient Week 10 | Change from Bsl Outpatient Week 14 | Change from Bsl Outpatient Week 18 | Change from Bsl Outpatient Week 22 | Change from Bsl Outpatient Week 26 | Change from Bsl Outpatient Week >26 |
---|
DVS SR - Adolescents | 7.45 | 1.79 | 0.70 | -0.95 | -0.70 | -1.40 | -1.65 | -2.45 | -2.15 | -2.35 | -2.10 |
,DVS SR - Children | 5.15 | 0.53 | -0.50 | -0.40 | -0.45 | -1.30 | -0.45 | -1.65 | -1.05 | -1.65 | -1.65 |
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Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)
ECG results meeting the criteria for PCI categorized as PR interval ≥200 milliseconds (msec); QT interval ≥480msec; QRS interval ≥120 msec; corrected QT (QTc) ≥500 msec ); >450 msec for males and >470 msec for females or increase of ≥60 msec or ≥30 msec change from baseline QTcB=QT corrected using Bazett formula; QTcF=QT corrected using the Fridericia formula. (NCT00669110)
Timeframe: Baseline (Extension study) up to Week 26 (Extension study)
Intervention | participants (Number) |
---|
| PR interval ≥200 msec | QRS interval ≥120 msec | QTcF interval ≥30 msec change from baseline | QTcB interval ≥30 msec change from baseline | QTcB interval ≥60 msec change from baseline | QTcB interval >470 or increase ≥60 msec (females) |
---|
DVS SR - Adolescents | 1 | 1 | 1 | 1 | 0 | 0 |
,DVS SR - Children | 0 | 0 | 5 | 6 | 1 | 1 |
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Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)
AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect. (NCT00669110)
Timeframe: Baseline (Extension study) up to Extension study Week 29 Follow up visit
Intervention | participants (Number) |
---|
| Adverse events | Serious adverse events |
---|
DVS SR - Adolescents | 15 | 0 |
,DVS SR - Children | 13 | 1 |
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Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males
Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Male pubertal development staged by size of the genitalia and development of pubic hair (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category. (NCT00669110)
Timeframe: Baseline (Extension study), Week 26 (Extension study)
Intervention | participants (Number) |
---|
| Penis: 0=no stage change | Penis: 1=change of 1 stage | Penis: 2=change of 2 stages | Pubic hair: 0=no stage change | Pubic hair: 1=change of 1 stage | Pubic hair: 2=change of 2 stages | Testes: 0=no stage change | Testes: 1=change of 1 stage | Testes: 2=change of 2 stages |
---|
DVS SR - Adolescents | 3 | 0 | 1 | 2 | 1 | 1 | 3 | 0 | 1 |
,DVS SR - Children | 4 | 1 | 0 | 2 | 3 | 0 | 3 | 2 | 0 |
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Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females
Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category. (NCT00669110)
Timeframe: Baseline (Extension study), Week 26 (Extension study)
Intervention | participants (Number) |
---|
| Breasts: 0=no stage change | Breasts: 1=change of 1 stage | Breasts: 2=change of 2 stages | Pubic hair: 0=no stage change | Pubic hair: 1=change of 1 stage | Pubic hair: 2=change of 2 stages |
---|
DVS SR - Adolescents | 1 | 1 | 1 | 2 | 0 | 1 |
,DVS SR - Children | 5 | 1 | 1 | 6 | 1 | 0 |
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Change From Baseline (Bsl) in Children's Depression Rating Scale - Revised (CDRS-R) Total Score at Final On-therapy Visit
CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms. (NCT00669110)
Timeframe: Baseline (Extension study), Extension study Outpatient Weeks 26 and >Week 26 (up to Week 29 or early termination)
Intervention | scores on a scale (Mean) |
---|
| Baseline mean | Change from Bsl Outpatient Week 26 | Change from Bsl Outpatient Week >26 |
---|
DVS SR - Adolescents | 33.70 | -1.95 | -1.70 |
,DVS SR - Children | 32.40 | -1.85 | -1.85 |
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Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI): Heart Rate (Low)
PCI criteria for females: heart rate (bpm) ranges from <68 and >126 at age 6 to <63 and >121 at age 11; heart rate from <63 and >121 at age 12 to <54 and >110 at age 17; heart rate <50 and >104 at age 18. Criteria for males: heart rate ranges from < 68 and >126 at age 6 to <63 and >121 at age 11; heart rate <58 and >116 at age 12 up <50 and >104 at age 17; heart rate <45 and >99 at age 18. Heart rates meeting the criteria for PCI categorized as low (less than the lower limit specified for age). (NCT00669110)
Timeframe: Baseline (Extension study) up to Week 26 (Extension study)
Intervention | participants (Number) |
---|
DVS SR - Children | 0 |
DVS SR - Adolescents | 2 |
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Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category. (NCT00669110)
Timeframe: Postbaseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study)
Intervention | participants (Number) |
---|
| Completed suicide: No | Suicide attempt: No | Preparatory acts - imminent suicidal behavior: No | Suicidal ideation: Yes | Suicidal ideation: No | Any suicidal behavior and/or ideation: Yes | Any suicidal behavior and/or ideation: No | Self-injurious behavior, no suicidal intent: No |
---|
DVS SR - Adolescents | 20 | 20 | 20 | 3 | 17 | 3 | 17 | 20 |
,DVS SR - Children | 20 | 20 | 20 | 0 | 20 | 0 | 20 | 20 |
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Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R)
CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission defined as a CDRS-R total score ≤28 (coded value of 1). (NCT00669110)
Timeframe: Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
Intervention | percentage of participants (Number) |
---|
| Outpatient Week 1 | Outpatient Week 2 | Outpatient Week 4 | Outpatient Week 6 | Outpatient Week 10 | Outpatient Week 14 | Outpatient Week 18 | Outpatient Week 22 | Outpatient Week 26 | Outpatient Week >26 |
---|
DVS SR - Adolescents | 21.1 | 25 | 20 | 25 | 25 | 25 | 40 | 35 | 30 | 25 |
,DVS SR - Children | 26.7 | 30 | 30 | 25 | 45 | 25 | 35 | 30 | 30 | 30 |
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Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Participant with response is defined as having a score of 1 (very much improved) or 2 (much improved). (NCT00669110)
Timeframe: Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
Intervention | percentage of participants (Number) |
---|
| Outpatient Week 1 | Outpatient Week 2 | Outpatient Week 4 | Outpatient Week 6 | Outpatient Week 10 | Outpatient Week 14 | Outpatient Week 18 | Outpatient Week 22 | Outpatient Week 26 | Outpatient Week >26 |
---|
DVS SR - Adolescents | 55 | 70 | 75 | 85 | 80 | 80 | 85 | 85 | 85 | 85 |
,DVS SR - Children | 80 | 80 | 80 | 70 | 70 | 75 | 85 | 80 | 85 | 85 |
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Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4
Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes. (NCT00683800)
Timeframe: Baseline and Week 4
Intervention | Units on a Scale (Mean) |
---|
DVS SR 100 mg | -0.47 |
Placebo | -0.19 |
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Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes
A mean decrease from baseline of at least 5.35 moderate to severe hot flushes at week 12 in the participants was considered clinically meaningful. (NCT00683800)
Timeframe: Baseline and Week 12
Intervention | Participants (Number) |
---|
DVS SR 100 mg | 117 |
Placebo | 75 |
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Number of Participants With Adjudicated Cerebrovascular Events - Probable TIA
"Adjudicated cerebrovascular events were identified using Standardized MedDRA Query (SMQ), for central nervous system haemorrhages and cerebrovascular conditions. Primary assessments included: 1) definite stroke, 2) probable stroke, 3) probable transient ischemic attack (TIA), and 4) no stroke or TIA." (NCT00683800)
Timeframe: Baseline up to Month 12
Intervention | Participants (Number) |
---|
DVS SR 100 mg | 1 |
Placebo | 0 |
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Number of Participants With Hepatic Events
Hepatic events were defined as incidence of increased Liver Function Test (AST [aspartate aminotransferase] or ALT [alanine aminotransferase]) levels greater than 5 times the ULN (upper limit of normal). (NCT00683800)
Timeframe: Baseline up to Month 12
Intervention | Participants (Number) |
---|
DVS SR 100 mg | 2 |
Placebo | 2 |
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Number of Participants With Ischemic Heart Disease
"Potential ischaemic cardiac events were identified using the Standardized MedDRA Query (SMQ) Ischemic Heart Disease." (NCT00683800)
Timeframe: Baseline up to Month 12
Intervention | Participants (Number) |
---|
DVS SR 100 mg | 4 |
Placebo | 2 |
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Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12
Severity: mild (heat sensation without sweating); moderate (heat sensation with sweating; able to continue activity); severe (heat sensation with sweating; causing cessation of activity). Average daily severity of hot flushes= (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). Days with no hot flushes: severity score=0. As it was derived from count data, there was no maximum; minimum score=0; higher values= worse outcomes. Adjusted mean: calculated using change from baseline=response variable, treatment=factor and baseline=covariate using observed cases. (NCT00683800)
Timeframe: Baseline, Month 6 and Month 12
Intervention | Units on a Scale (Mean) |
---|
| Month 6 (n= 125, 124) | Month 12 (n= 112, 102) |
---|
DVS SR 100 mg | -0.87 | -0.78 |
,Placebo | -0.56 | -0.45 |
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Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. Adjusted mean was calculated by using change from baseline as response variable, treatment as factor, and baseline as covariate using the observed cases. (NCT00683800)
Timeframe: Baseline, Month 6 and Month 12
Intervention | Hot Flushes (Mean) |
---|
| Month 6 (n= 125, 124) | Month 12 (n= 112, 102) |
---|
DVS SR 100 mg | -8.65 | -7.98 |
,Placebo | -6.61 | -5.17 |
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Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12
GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms. (NCT00683800)
Timeframe: Baseline and Month 12
Intervention | Units on a Scale (Mean) |
---|
| Total Score | Anxiety Scale | Depression Scale | Sexual Dysfunction Scale | Psychological Scale | Somatic Scale | Vasomotor Scale |
---|
DVS SR 100 mg | -10.60 | -3.25 | -2.66 | -0.51 | -5.88 | -1.63 | -2.64 |
,Placebo | -8.89 | -2.69 | -2.04 | -0.43 | -4.70 | -1.61 | -2.19 |
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Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6
GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms. (NCT00683800)
Timeframe: Baseline and Month 6
Intervention | Units on a Scale (Mean) |
---|
| Total Score | Anxiety Scale | Depression Scale | Sexual Dysfunction Scale | Psychological Scale | Somatic Scale | Vasomotor Scale |
---|
DVS SR 100 mg | -9.84 | -3.06 | -2.35 | -0.46 | -5.39 | -1.49 | -2.55 |
,Placebo | -7.97 | -2.41 | -1.77 | -0.41 | -4.15 | -1.31 | -2.14 |
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Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12
GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms. (NCT00683800)
Timeframe: Baseline and Week 12
Intervention | Units on a Scale (Mean) |
---|
| Baseline: Total Score | Baseline: Anxiety Scale | Baseline: Depression Scale | Baseline: Sexual Dysfunction Scale | Baseline: Psychological Scale | Baseline: Somatic Scale | Baseline: Vasomotor Scale | Week 12: Total Score | Week 12: Anxiety Scale | Week 12: Depression Scale | Week 12: Sexual Dysfunction Scale | Week 12: Psychological Scale | Week 12: Somatic Scale | Week 12: Vasomotor Scale |
---|
DVS SR 100 mg | 22.48 | 6.43 | 4.92 | 1.60 | 11.35 | 4.54 | 4.99 | -9.18 | -2.81 | -2.23 | -0.41 | -5.04 | -1.24 | -2.50 |
,Placebo | 22.04 | 6.36 | 4.84 | 1.65 | 11.19 | 4.21 | 4.99 | -6.84 | -2.06 | -1.55 | -0.36 | -3.62 | -1.02 | -1.85 |
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Number of Participants With Adjudicated Cerebrovascular Events - Any Stroke
"Adjudicated cerebrovascular events were identified using Standardized MedDRA Query (SMQ), for central nervous system haemorrhages and cerebrovascular conditions. Primary assessments included: 1) definite stroke, 2) probable stroke, 3) probable transient ischemic attack (TIA), and 4) no stroke or TIA." (NCT00683800)
Timeframe: Baseline up to Month 12
Intervention | Participants (Number) |
---|
| Any Stroke (Definite or Probable) | Definite Stroke | Probable Stroke |
---|
DVS SR 100 mg | 1 | 0 | 1 |
,Placebo | 0 | 0 | 0 |
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Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events
Adjudicated ischemic cardiovascular events were a composite of: a) Coronary Heart Disease (CHD)-related death; b) New Myocardial Infarction (MI) (non-procedure-related MI); c) Documented new onset of unstable angina requiring hospitalization; d) Unscheduled coronary revascularization procedures (percutaneous coronary intervention) or bypass grafting. (NCT00683800)
Timeframe: Baseline up to Month 12
Intervention | Participants (Number) |
---|
| Any ischemic CV event | CHD related death | New MI | New Onset of Unstable Angina | Unscheduled Coronary Revascularization Procedures |
---|
DVS SR 100 mg | 0 | 0 | 0 | 0 | 0 |
,Placebo | 1 | 0 | 1 | 0 | 0 |
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Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. (NCT00683800)
Timeframe: Baseline, Week 4 and Week 12
Intervention | Percentage of participants (Number) |
---|
| Week 4 | Week 12 |
---|
DVS SR 100 mg | 58.47 | 67.93 |
,Placebo | 28.89 | 44.20 |
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Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. (NCT00683800)
Timeframe: Baseline, Week 4 and Week 12
Intervention | Percentage of participants (Number) |
---|
| Week 4 | Week 12 |
---|
DVS SR 100 mg | 32.79 | 41.30 |
,Placebo | 10.00 | 18.23 |
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Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12
PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse). (NCT00683800)
Timeframe: Month 12
Intervention | Percentage of Participants (Number) |
---|
| 1= Very Much Improved | 2= Much Improved | 3= Minimally Improved | 4= No Change | 5= Minimally Worse | 6= Much Worse | 7= Very Much Worse |
---|
DVS SR 100 mg | 31.0 | 29.2 | 21.1 | 12.7 | 2.4 | 2.7 | 0.9 |
,Placebo | 19.9 | 24.5 | 21.5 | 26.8 | 4.4 | 2.0 | 0.9 |
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Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12
PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse). (NCT00683800)
Timeframe: Month 12
Intervention | Percentage of Participants (Number) |
---|
| 1= Very Much Improved | 2= Much Improved | 3= Minimally Improved | 4= No Change | 5= Minimally Worse | 6= Much Worse | 7= Very Much Worse |
---|
DVS SR 100 mg | 37.2 | 24.4 | 21.5 | 10.5 | 1.2 | 4.1 | 1.2 |
,Placebo | 13.7 | 18.3 | 25.1 | 36.0 | 5.1 | 1.7 | 0.0 |
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Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6
PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse). (NCT00683800)
Timeframe: Month 6
Intervention | Percentage of Participants (Number) |
---|
| 1= Very Much Improved | 2= Much Improved | 3= Minimally Improved | 4= No Change | 5= Minimally Worse | 6= Much Worse | 7= Very Much Worse |
---|
DVS SR 100 mg | 28.9 | 32.3 | 20.5 | 11.6 | 3.5 | 2.1 | 1.1 |
,Placebo | 17.1 | 27.7 | 20.6 | 26.2 | 5.2 | 2.6 | 0.6 |
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Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12
PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse). (NCT00683800)
Timeframe: Week 12
Intervention | Percentage of Participants (Number) |
---|
| 1= Very Much Improved | 2= Much Improved | 3= Minimally Improved | 4= No Change | 5= Minimally Worse | 6= Much Worse | 7= Very Much Worse |
---|
DVS SR 100 mg | 25.8 | 32.3 | 23.3 | 11.5 | 4.1 | 2.2 | 0.8 |
,Placebo | 13.1 | 25.5 | 25.1 | 29.3 | 4.5 | 1.7 | 0.7 |
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Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6
PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse). (NCT00683800)
Timeframe: Month 6
Intervention | Percentage of Participants (Number) |
---|
| 1= Very Much Improved | 2= Much Improved | 3= Minimally Improved | 4= No Change | 5= Minimally Worse | 6= Much Worse | 7= Very Much Worse |
---|
DVS SR 100 mg | 34.9 | 32.6 | 15.7 | 11.0 | 2.3 | 2.9 | 0.6 |
,Placebo | 14.9 | 25.7 | 23.4 | 29.7 | 4.0 | 2.3 | 0.0 |
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Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12
PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse). (NCT00683800)
Timeframe: Week 12
Intervention | Percentage of Participants (Number) |
---|
| 1= Very Much Improved | 2= Much Improved | 3= Minimally Improved | 4= No Change | 5= Minimally Worse | 6= Much Worse | 7= Very Much Worse |
---|
DVS SR 100 mg | 26.7 | 35.5 | 17.4 | 12.8 | 2.9 | 3.5 | 1.2 |
,Placebo | 7.4 | 22.3 | 29.7 | 34.3 | 4.6 | 1.7 | 0.0 |
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Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12
PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe). (NCT00683800)
Timeframe: Month 12
Intervention | Percentage of Participants (Number) |
---|
| 1= None | 2= Minimal | 3= Mild | 4= Moderate | 5= Severe |
---|
DVS SR 100 mg | 10.1 | 32.2 | 25.9 | 21.6 | 10.3 |
,Placebo | 7.1 | 27.8 | 21.0 | 29.7 | 14.4 |
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Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6
PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe). (NCT00683800)
Timeframe: Month 6
Intervention | Percentage of Participants (Number) |
---|
| 1= None | 2= Minimal | 3= Mild | 4= Moderate | 5= Severe |
---|
DVS SR 100 mg | 8.5 | 32.2 | 27.3 | 22.9 | 9.0 |
,Placebo | 5.7 | 25.5 | 23.1 | 31.1 | 14.6 |
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Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12
PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe). (NCT00683800)
Timeframe: Week 12
Intervention | Percentage of Participants (Number) |
---|
| 1= None | 2= Minimal | 3= Mild | 4= Moderate | 5= Severe |
---|
DVS SR 100 mg | 8.8 | 27.8 | 28.9 | 24.9 | 9.6 |
,Placebo | 5.0 | 18.5 | 26.5 | 33.8 | 16.2 |
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Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12
PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe). (NCT00683800)
Timeframe: Month 12
Intervention | Percentage of Participants (Number) |
---|
| 1= None | 2= Minimal | 3= Mild | 4= Moderate | 5= Severe |
---|
DVS SR 100 mg | 9.3 | 28.5 | 26.7 | 18.0 | 17.4 |
,Placebo | 4.0 | 17.1 | 12.6 | 39.4 | 26.9 |
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Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6
PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe). (NCT00683800)
Timeframe: Month 6
Intervention | Percentage of Participants (Number) |
---|
| 1= None | 2= Minimal | 3= Mild | 4= Moderate | 5= Severe |
---|
DVS SR 100 mg | 12.2 | 29.7 | 27.3 | 16.9 | 14.0 |
,Placebo | 2.9 | 18.3 | 17.7 | 34.3 | 26.9 |
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Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12
PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe). (NCT00683800)
Timeframe: Week 12
Intervention | Percentage of Participants (Number) |
---|
| 1= None | 2= Minimal | 3= Mild | 4= Moderate | 5= Severe |
---|
DVS SR 100 mg | 8.1 | 20.3 | 29.1 | 24.4 | 18.0 |
,Placebo | 1.7 | 10.9 | 16.6 | 42.9 | 28.0 |
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Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. (NCT00683800)
Timeframe: Baseline and Week 12
Intervention | Hot Flushes (Mean) |
---|
DVS SR 100 mg | -7.31 |
Placebo | -4.52 |
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Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. (NCT00683800)
Timeframe: Baseline and Week 4
Intervention | Hot Flushes (Mean) |
---|
DVS SR 100 mg | -6.52 |
Placebo | -3.64 |
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Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12
Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes. (NCT00683800)
Timeframe: Baseline and Week 12
Intervention | Units on a Scale (Mean) |
---|
DVS SR 100 mg | -0.59 |
Placebo | -0.28 |
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Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients
The efficacy variable was the change from baseline on the numeric rating scale (NRS). The time point was the average pain score during the last data-analysis-interval of week 8, data analysis interval. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain. (NCT00696787)
Timeframe: Baseline and 8 weeks
Intervention | units on scale (Mean) |
---|
Placebo | -2.00 |
DVS SR | -1.64 |
Pregabalin | -1.45 |
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Change From Baseline on the Numeric Rating Scale (NRS)
The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain. (NCT00696787)
Timeframe: Baseline and 8 weeks
Intervention | units on scale (Mean) |
---|
Placebo | -1.98 |
DVS SR | -1.60 |
Pregabalin | -1.70 |
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Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).
A MADRS remission was defined as MADRS Total Score = 10 and >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit). (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.
Intervention | Percentage of participants (Number) |
---|
| Week 9 (N=61, 117, 116, 121) | Week 10 (N=62, 119, 118, 126) | Week 11 (N=62, 119, 118, 126) | Week 12 (N=62, 119, 118, 126) | Week 13 (N=62, 119, 118, 126) | Week 14 (N=62, 119, 118, 126) |
---|
OPC-34712 0.15 mg Fixed Dose | 3.28 | 8.06 | 12.9 | 21.0 | 19.4 | 22.6 |
,OPC-34712 0.5 ± 0.25 mg Low Dose | 1.71 | 5.04 | 10.1 | 10.1 | 16.8 | 15.1 |
,OPC-34712 1.5 ± 0.5 mg High Dose | 1.72 | 10.2 | 14.4 | 19.5 | 15.3 | 23.7 |
,Placebo | 4.13 | 8.73 | 11.1 | 10.3 | 15.1 | 13.5 |
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Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).
A MADRS response was defined as >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit). (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.
Intervention | Percentage of participants (Number) |
---|
| Week 9 (N=61, 117, 116, 121) | Week 10 (N=62, 119, 118, 126) | Week 11 (N=62, 119, 118, 126) | Week 12 (N=62, 119, 118, 126) | Week 13 (N=62, 119, 118, 126) | Week 14 (N=62, 119, 118, 126) |
---|
OPC-34712 0.15 mg Fixed Dose | 4.92 | 8.06 | 19.4 | 30.6 | 24.2 | 27.4 |
,OPC-34712 0.5 ± 0.25 mg Low Dose | 6.84 | 8.40 | 15.1 | 15.1 | 22.7 | 20.2 |
,OPC-34712 1.5 ± 0.5 mg High Dose | 2.59 | 11.0 | 18.6 | 25.4 | 25.4 | 34.7 |
,Placebo | 8.26 | 9.52 | 13.5 | 11.9 | 18.3 | 19.8 |
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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction).
The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 16 (Overall Life Satisfaction) will yield a separate subscore. (NCT00797966)
Timeframe: Week 8 to Week 14
Intervention | Units on a scale (Mean) |
---|
OPC-34712 0.15 mg Fixed Dose | 0.30 |
OPC-34712 0.5 ± 0.25 mg Low Dose | 0.30 |
OPC-34712 1.5 ± 0.5 mg High Dose | 0.35 |
Placebo | 0.28 |
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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score.
"The HAM-D17 is utilized as a secondary assessment of a participant's level of depression. The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the best rating and the highest score (2 or 4) is the worst rating. The possible total scores are from 0 to 52." (NCT00797966)
Timeframe: Week 8 to Week 14
Intervention | Units on a scale (Least Squares Mean) |
---|
OPC-34712 0.15 mg Fixed Dose | -5.77 |
OPC-34712 0.5 ± 0.25 mg Low Dose | -5.28 |
OPC-34712 1.5 ± 0.5 mg High Dose | -6.59 |
Placebo | -5.23 |
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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
CGI-S items are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14. (NCT00797966)
Timeframe: Week 8 to Week 14
Intervention | Units on a scale (Least Squares Mean) |
---|
OPC-34712 0.15 mg Fixed Dose | -0.83 |
OPC-34712 0.5 ± 0.25 mg Low Dose | -0.81 |
OPC-34712 1.5 ± 0.5 mg High Dose | -1.06 |
Placebo | -0.71 |
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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication).
The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 15 (Satisfaction with Medication) will yield a separate subscore. (NCT00797966)
Timeframe: Week 8 to Week 14
Intervention | Units on a scale (Mean) |
---|
OPC-34712 0.15 mg Fixed Dose | 0.02 |
OPC-34712 0.5 ± 0.25 mg Low Dose | 0.01 |
OPC-34712 1.5 ± 0.5 mg High Dose | 0.02 |
Placebo | 0.00 |
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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores).
The Sheehan Disability Scale (SDS) is a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable. (NCT00797966)
Timeframe: Week 8 to Week 14
Intervention | Units on a scale (Least Squares Mean) |
---|
OPC-34712 0.15 mg Fixed Dose | -0.84 |
OPC-34712 0.5 ± 0.25 mg Low Dose | -0.80 |
OPC-34712 1.5 ± 0.5 mg High Dose | -1.27 |
Placebo | -0.61 |
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Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.
"The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place." (NCT00797966)
Timeframe: Week 8 to Week 14
Intervention | Units on a scale (Least Squares Mean) |
---|
OPC-34712 0.15 mg Fixed Dose | -6.62 |
OPC-34712 0.5 ± 0.25 mg Low Dose | -6.46 |
OPC-34712 1.5 ± 0.5 mg High Dose | -8.23 |
Placebo | -6.09 |
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Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.
"The IDS-SR is a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the best rating and 3 being the worst rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items are recorded. If the number of items was at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place." (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14
Intervention | Units on a scale (Mean) |
---|
| Week 9 (N=61, 117,116,121) | Week 10 (N=62, 119, 118, 126) | Week 11 (N=62, 119, 118, 126) | Week 12 (N=62, 119, 118, 126) | Week 13 (N=62, 119, 118, 126) | Week 14 (N=62, 119, 118, 126) |
---|
OPC-34712 0.15 mg Fixed Dose | -0.98 | -2.13 | -3.58 | -5.11 | -5.34 | -5.55 |
,OPC-34712 0.5 ± 0.25 mg Low Dose | -1.88 | -2.58 | -3.41 | -3.77 | -5.22 | -4.96 |
,OPC-34712 1.5 ± 0.5 mg High Dose | -2.04 | -4.08 | -4.82 | -5.77 | -5.65 | -6.74 |
,Placebo | -0.98 | -1.62 | -2.09 | -2.07 | -2.37 | -3.08 |
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Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
"The MADRS is utilized as the primary efficacy assessment of a patient's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place." (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12 and 13.
Intervention | Units on a scale (Mean) |
---|
| Week 9 (N=61,117,116,121) | Week 10 (N=62,119,118,126) | Week 11 (N=62,119,118,126) | Week 12 (N=62,119,118,126) | Week 13 (N=62,119,118,126) |
---|
OPC-34712 0.15 mg Fixed Dose | -2.13 | -3.69 | -5.53 | -6.97 | -6.90 |
,OPC-34712 0.5 ± 0.25 mg Low Dose | -3.00 | -3.78 | -5.71 | -6.31 | -6.76 |
,OPC-34712 1.5 ± 0.5 mg High Dose | -2.75 | -4.97 | -5.88 | -7.01 | -7.18 |
,Placebo | -2.48 | -3.64 | -4.40 | -4.41 | -5.47 |
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Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
CGI-S items are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14. (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12 and 13.
Intervention | Units on a scale (Mean) |
---|
| Week 9 (N=62,117,116,121) | Week 10 (N=62,119,118,126) | Week 11 (N=62,119,118,126) | Week 12 (N=62,119,118,126) | Week 13 (N=62,119,118,126) |
---|
OPC-34712 0.15 mg Fixed Dose | -0.21 | -0.42 | -0.53 | -0.76 | -0.74 |
,OPC-34712 0.5 ± 0.25 mg Low Dose | -0.26 | -0.39 | -0.53 | -0.66 | -0.78 |
,OPC-34712 1.5 ± 0.5 mg High Dose | -0.33 | -0.61 | -0.69 | -0.86 | -0.88 |
,Placebo | -0.21 | -0.40 | -0.47 | -0.52 | -0.59 |
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Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.
CGI-I items are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI-I was assessed at each visit in Phase B, and improvement is judged with respect to the participant's condition at baseline. CGI-I was also assessed at each visit in Phase B, but in that phase improvement is judged with respect to the partcipant's condition at the end of Phase A. (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.
Intervention | Units on a scale (Mean) |
---|
| Week 9 (N=62, 117, 116, 121) | Week 10 (N=62, 119, 118, 126) | Week 11 (N=62, 119, 118, 126) | Week 12 (N=62, 119, 118, 126) | Week 13 (N=62, 119, 118, 126) | Week 14 (N=62, 119, 118, 126) |
---|
OPC-34712 0.15 mg Fixed Dose | 3.39 | 3.16 | 2.94 | 2.87 | 2.85 | 2.74 |
,OPC-34712 0.5 ± 0.25 mg Low Dose | 3.30 | 3.19 | 3.02 | 2.90 | 2.76 | 2.78 |
,OPC-34712 1.5 ± 0.5 mg High Dose | 3.20 | 2.95 | 2.80 | 2.70 | 2.64 | 2.52 |
,Placebo | 3.31 | 3.11 | 2.94 | 2.95 | 2.90 | 2.83 |
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Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).
CGI-I response is defined as CGI-I of 1 [very much improved] or 2 [much improved]. (NCT00797966)
Timeframe: Week 9, 10, 11, 12, 13 and 14.
Intervention | percentage of participants (Number) |
---|
| Week 9 (N=62, 117, 116, 121) | Week 10 (N=62, 119, 118, 126) | Week 11 (N=62, 119, 118, 126) | Week 12 (N=62, 119, 118, 126) | Week 13 (N=62, 119, 118, 126) | Week 14 (N=62, 119, 118, 126) |
---|
OPC-34712 0.15 mg Fixed Dose | 16.1 | 25.8 | 32.3 | 35.5 | 37.1 | 38.7 |
,OPC-34712 0.5 ± 0.25 mg Low Dose | 11.1 | 17.6 | 29.4 | 33.6 | 37.0 | 37.0 |
,OPC-34712 1.5 ± 0.5 mg High Dose | 14.7 | 24.6 | 35.6 | 42.4 | 49.2 | 52.5 |
,Placebo | 14.9 | 27.0 | 29.4 | 31.7 | 33.3 | 41.3 |
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Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms." (NCT00798707)
Timeframe: Week 8 to 10 (or ET)
Intervention | Units on a scale (Mean) |
---|
| Week 8 (or ET) (n=96,88,100) | Week 9 (or ET + 1 week) (n=93,84,98) | Week 10 (or ET + 2 weeks) (n=83,76,89) |
---|
DVS SR 25 mg | 0.63 | 1.38 | 0.74 |
,DVS SR 50 mg | 0.62 | 1.50 | 0.63 |
,Placebo | 0.67 | 1.08 | 0.94 |
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Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. (NCT00798707)
Timeframe: Week 8 (or ET)
Intervention | Participants (Number) |
---|
| 1=Very much improved | 2=Much improved | 3=Minimally improved | 4=No change | 5=Minimally worse | 6=Much worse | 7=Very much worse |
---|
DVS SR 25 mg | 57 | 61 | 70 | 37 | 5 | 1 | 1 |
,DVS SR 50 mg | 68 | 62 | 61 | 36 | 4 | 5 | 0 |
,Placebo | 48 | 61 | 62 | 52 | 4 | 3 | 1 |
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Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)
"C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of Yes on Actual Attempt),preparatory acts toward imminent suicidal behavior (3)(Yes on Preparatory Acts or Behavior),suicidal ideation (4)(Yes on Wish to be dead,Non-Specific Active Suicidal Thoughts,Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)(Yes on Has subject engaged in Non-suicidal Self-Injurious Behavior)." (NCT00798707)
Timeframe: Week 8 (or ET)
Intervention | Participants (Number) |
---|
| Completed suicide | Suicide attempt | Preparatory acts toward imminent suicidal behavior | Suicidal ideation | Any suicidal behavior and/or ideation | Self-injurious behavior, no suicidal intent |
---|
DVS SR 25 mg | 0 | 0 | 0 | 50 | 50 | 1 |
,DVS SR 50 mg | 0 | 1 | 0 | 47 | 47 | 1 |
,Placebo | 0 | 0 | 0 | 42 | 42 | 0 |
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Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)
SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30. (NCT00798707)
Timeframe: Baseline and Week 8 (or ET)
Intervention | Units on a scale (Mean) |
---|
| Total Score (n=227,224,235) | Work/Studies Component (n=227,225,235) | Social Life Component (n=229,231,235) | Family Life/Home Responsibilities (n=14,2,13) |
---|
DVS SR 25 mg | -3.26 | -1.07 | -1.26 | -1.83 |
,DVS SR 50 mg | -3.23 | -1.12 | -1.21 | -0.97 |
,Placebo | -2.17 | -0.77 | -0.86 | -0.54 |
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Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)
ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week should be instructed to not complete questions 3 through 5. (NCT00798707)
Timeframe: Week 8 (or ET)
Intervention | Percentage of Participants (Number) |
---|
Placebo | 55.0 |
DVS SR 25 mg | 52.7 |
DVS SR 50 mg | 55.8 |
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Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)
A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). (NCT00798707)
Timeframe: Week 8 (or ET)
Intervention | Participants (Number) |
---|
Placebo | 68 |
DVS SR 25 mg | 81 |
DVS SR 50 mg | 102 |
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Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)
A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50. (NCT00798707)
Timeframe: Week 8 (or ET)
Intervention | Participants (Number) |
---|
Placebo | 80 |
DVS SR 25 mg | 97 |
DVS SR 50 mg | 109 |
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Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)
CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. (NCT00798707)
Timeframe: Week 8 (or ET)
Intervention | Participants (Number) |
---|
Placebo | 109 |
DVS SR 25 mg | 118 |
DVS SR 50 mg | 130 |
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Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)
WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life). (NCT00798707)
Timeframe: Baseline and Week 8 (or ET)
Intervention | Units on a scale (Mean) |
---|
Placebo | 2.62 |
DVS SR 25 mg | 3.43 |
DVS SR 50 mg | 3.25 |
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Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. (NCT00798707)
Timeframe: Baseline and Week 8 (or ET)
Intervention | Units on a scale (Mean) |
---|
Placebo | -1.03 |
DVS SR 25 mg | -1.22 |
DVS SR 50 mg | -1.24 |
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Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)
Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50. (NCT00798707)
Timeframe: Week 8 (or ET)
Intervention | Participants (Number) |
---|
Placebo | 44 |
DVS SR 25 mg | 40 |
DVS SR 50 mg | 62 |
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Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)
MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). (NCT00798707)
Timeframe: Baseline and Week 8 (or ET)
Intervention | Units on a scale (Mean) |
---|
Placebo | -9.23 |
DVS SR 25 mg | -10.23 |
DVS SR 50 mg | -11.29 |
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Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)
HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4. (NCT00798707)
Timeframe: Baseline and Week 8 (or ET)
Intervention | Units on a scale (Mean) |
---|
Placebo | -4.94 |
DVS SR 25 mg | -5.03 |
DVS SR 50 mg | -5.65 |
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Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)
HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50. (NCT00798707)
Timeframe: Baseline and Week 8 (or ET)
Intervention | Units on a scale (Mean) |
---|
Placebo | -8.52 |
DVS SR 25 mg | -8.98 |
DVS SR 50 mg | -10.02 |
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Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12
WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension. Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing. (NCT00824291)
Timeframe: At Baseline and Week 12.
Intervention | Scores on a scale (Mean) |
---|
DVS SR 50 mg | -13.39 |
Placebo | -10.95 |
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Change From Baseline on Work and Activities Item of HAM-D17 at Week 12
The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4. (NCT00824291)
Timeframe: At Baseline and Week 12.
Intervention | Scores on a scale (Mean) |
---|
DVS SR 50 mg | -1.68 |
Placebo | -1.45 |
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Change From Baseline on Stress and Social Support Scales at Week 12
Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends. (NCT00824291)
Timeframe: At Baseline and Week 12.
Intervention | Scores on a scale (Mean) |
---|
DVS SR 50 mg | -2.53 |
Placebo | -2.14 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12
Participant rated scale was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Individual item scores range from 0 to 10. (NCT00824291)
Timeframe: At Baseline and Week 12.
Intervention | Scores on a scale (Mean) |
---|
DVS SR 50 mg | -9.41 |
Placebo | -8.08 |
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Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12
HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline. (NCT00824291)
Timeframe: At Baseline and Week 12.
Intervention | Scores on a scale (Mean) |
---|
DVS SR 50 mg | -12.61 |
Placebo | -10.50 |
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Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). (NCT00824291)
Timeframe: At Baseline and Week 12.
Intervention | Scores on a scale (Mean) |
---|
DVS SR 50 mg | -18.44 |
Placebo | -16.18 |
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Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. (NCT00824291)
Timeframe: At Baseline and Week 12.
Intervention | Scores on a scale (Number) |
---|
| 1 (Very Much Improved) | 2 (Much Improved) | 3 (Minimally Improved) | 4 (No Change) | 5 (Minimally Worse) | 6 (Much Worse) | 7 (Very Much Worse) |
---|
DVS SR 50 mg | 69 | 68 | 77 | 56 | 14 | 1 | 0 |
,Placebo | 23 | 30 | 31 | 43 | 15 | 0 | 0 |
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Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Change = score at observation minus score at baseline. (NCT00824291)
Timeframe: At Baseline and Week 12.
Intervention | Scores on a scale (Number) |
---|
| 1 (Very Much Improved) | 2 (Much Improved) | 3 (Minimally Improved) | 4 (No Change) | 5 (Minimally Worse) | 6 (Much Worse) | 7 (Very Much Worse) |
---|
DVS SR 50 mg | 103 | 84 | 53 | 34 | 10 | 0 | 1 |
,Placebo | 31 | 44 | 31 | 30 | 5 | 1 | 0 |
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Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score
"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity. FOT evaluation is defined as the last on-therapy evaluation, regardless of the number of days on therapy. Analysis on Observed cases (non-missing data) and Last observation carried forward (LOCF); LOCF method of imputation for any missing value at any visit." (NCT00831415)
Timeframe: Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation
Intervention | scores on a scale (Mean) |
---|
| LOCF - change at FOT (n=304) | Observed cases - change at Day 308 (n=224) |
---|
DVS SR | -4.76 | -5.82 |
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Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score
CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected. (NCT00831415)
Timeframe: Baseline (Extension Study) up to Day 308 or FOT Evaluation
Intervention | scores on a scale (Mean) |
---|
| LOCF - change at FOT (n=304) | Observed cases - change at Day 308 (n=224) |
---|
DVS SR | -0.82 | -0.95 |
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Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be an SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly. (NCT00831415)
Timeframe: Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment
Intervention | percentage of participants (Number) |
---|
| Adverse Events | Serious Adverse Events |
---|
DVS SR | 81.3 | 2.6 |
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Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)
CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. (NCT00831415)
Timeframe: Day 308 or FOT Evaluation
Intervention | participants (Number) |
---|
| 1=Very much improved | 2=Much improved | 3=Minimally improved | 4=No change | 5=Minimally worse | 6=Much worse | 7=Very much worse |
---|
DVS SR | 164 | 82 | 36 | 15 | 6 | 1 | 0 |
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Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)
HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50. (NCT00863798)
Timeframe: Baseline and Week 8 (or ET)
Intervention | Units on a scale (Mean) |
---|
Placebo | -8.42 |
DVS SR 10 mg | -9.28 |
DVS SR 50 mg | -8.92 |
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Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)
"C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of Yes on Actual Attempt),preparatory acts toward imminent suicidal behavior (3)(Yes on Preparatory Acts or Behavior),suicidal ideation (4)(Yes on Wish to be dead,Non-Specific Active Suicidal Thoughts,Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)(Yes on Has subject engaged in Non-suicidal Self-Injurious Behavior)." (NCT00863798)
Timeframe: Week 8 (or ET)
Intervention | Participants (Number) |
---|
| Completed suicide | Suicide attempt | Preparatory acts toward imminent suicidal behavior | Suicidal ideation | Any suicidal behavior and/or ideation | Self-injurious behavior, no suicidal intent |
---|
DVS SR 10 mg | 0 | 1 | 0 | 43 | 43 | 0 |
,DVS SR 50 mg | 0 | 0 | 1 | 45 | 45 | 0 |
,Placebo | 0 | 0 | 0 | 56 | 56 | 1 |
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Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. (NCT00863798)
Timeframe: Week 8 (or ET)
Intervention | Participants (Number) |
---|
| 1=Very much improved | 2=Much improved | 3=Minimally improved | 4=No change | 5=Minimally worse | 6=Much worse | 7=Very much worse |
---|
DVS SR 10 mg | 50 | 75 | 51 | 46 | 4 | 0 | 0 |
,DVS SR 50 mg | 55 | 53 | 64 | 49 | 3 | 0 | 0 |
,Placebo | 49 | 54 | 51 | 61 | 5 | 3 | 0 |
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Discontinuation-Emergent Signs and Symptoms (DESS)
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms. (NCT00863798)
Timeframe: Week 8 to 10 (or ET)
Intervention | Units on a scale (Mean) |
---|
| Week 8 (or ET) (n=190,194,191) | Week 9 ( or ET + 1 week) (n=178,185,186) | Week 10 (or ET + 2 weeks (n=170,182,182) |
---|
DVS SR 10 mg | 0.80 | 1.08 | 0.91 |
,DVS SR 50 mg | 0.83 | 1.98 | 1.07 |
,Placebo | 0.72 | 1.26 | 0.90 |
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Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)
ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week were instructed to not complete questions 3 through 5. (NCT00863798)
Timeframe: Week 8 (or ET)
Intervention | Percentage of Participants (Number) |
---|
Placebo | 52.0 |
DVS SR 10 mg | 48.6 |
DVS SR 50 mg | 59.5 |
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Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)
A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). (NCT00863798)
Timeframe: Week 8 (or ET)
Intervention | Participants (Number) |
---|
Placebo | 84 |
DVS SR 10 mg | 95 |
DVS SR 50 mg | 90 |
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Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)
A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50. (NCT00863798)
Timeframe: Week 8 (or ET)
Intervention | Participants (Number) |
---|
Placebo | 85 |
DVS SR 10 mg | 100 |
DVS SR 50 mg | 91 |
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Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)
CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. (NCT00863798)
Timeframe: Week 8 (or ET)
Intervention | Participants (Number) |
---|
Placebo | 103 |
DVS SR 10 mg | 125 |
DVS SR 50 mg | 108 |
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Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)
Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50. (NCT00863798)
Timeframe: Week 8 (or ET)
Intervention | Participants (Number) |
---|
Placebo | 42 |
DVS SR 10 mg | 52 |
DVS SR 50 mg | 39 |
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Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)
WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life). (NCT00863798)
Timeframe: Baseline and Week 8 (or ET)
Intervention | Units on a scale (Mean) |
---|
Placebo | 2.96 |
DVS SR 10 mg | 4.51 |
DVS SR 50 mg | 3.73 |
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Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. (NCT00863798)
Timeframe: Baseline and Week 8 (or ET )
Intervention | Units on a scale (Mean) |
---|
Placebo | -1.08 |
DVS SR 10 mg | -1.23 |
DVS SR 50 mg | -1.11 |
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Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)
MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). (NCT00863798)
Timeframe: Baseline and Week 8 (or ET)
Intervention | Units on a scale (Mean) |
---|
Placebo | -9.87 |
DVS SR 10 mg | -11.28 |
DVS SR 50 mg | -10.76 |
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Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)
HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. 0=none/absent and 22=most severe.The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4. (NCT00863798)
Timeframe: Baseline and Week 8 (or ET )
Intervention | Units on a scale (Mean) |
---|
Placebo | -4.75 |
DVS SR 10 mg | -5.49 |
DVS SR 50 mg | -5.19 |
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Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)
SDS: a self-administered tools that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30. (NCT00863798)
Timeframe: Baseline and Week 8 (or ET)
Intervention | Units on a scale (Mean) |
---|
| Total Score (n=220,223,219) | Work/Studies Component(n=220,223,219) | Social Life and Leisure Activities(n=222,224,221) | Family Life/Home Responsibilities (n=222,224,221) |
---|
DVS SR 10 mg | -4.09 | -1.10 | -1.58 | -1.43 |
,DVS SR 50 mg | -3.78 | -1.14 | -1.36 | -1.20 |
,Placebo | -2.63 | -0.61 | -1.08 | -0.98 |
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Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Remission defined as HAM-D17 total score ≤7. (NCT00887224)
Timeframe: Double-blind phase Week 26 (Study Day 322)
Intervention | participants (Number) |
---|
Placebo | 148 |
DVS SR 50 mg | 201 |
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Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185
Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325). (NCT00887224)
Timeframe: Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)
Intervention | percent estimated probability (Number) |
---|
Placebo | 30.2 |
DVS SR 50 mg | 14.3 |
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Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase
CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range of 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected. Change from baseline mean=adjusted mean change calculated using mixed-effects model for repeated measures (MMRM). (NCT00887224)
Timeframe: Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)
Intervention | scores on a scale (Mean) |
---|
| Change from Baseline at DB Week 1 | Change from Baseline at DB Week 2 | Change from Baseline at DB Week 3 | Change from Baseline at DB Week 4 | Change from Baseline at DB Week 6 | Change from Baseline at DB Week 10 | Change from Baseline at DB Week 14 | Change from Baseline at DB Week 18 | Change from Baseline at DB Week 22 | Change from Baseline at DB Week 26 |
---|
DVS SR 50 mg | 0.03 | 0.09 | 0.07 | 0.06 | 0.06 | 0.11 | 0.05 | 0.09 | 0.13 | 0.09 |
,Placebo | 0.03 | 0.18 | 0.21 | 0.23 | 0.32 | 0.39 | 0.38 | 0.42 | 0.56 | 0.53 |
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Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM. (NCT00887224)
Timeframe: Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)
Intervention | scores on a scale (Mean) |
---|
| Change from Baseline at DB Week 1 | Change from Baseline at DB Week 2 | Change from Baseline at DB Week 3 | Change from Baseline at DB Week 4 | Change from Baseline at DB Week 6 | Change from Baseline at DB Week 10 | Change from Baseline at DB Week 14 | Change from Baseline at DB Week 18 | Change from Baseline at DB Week 22 | Change from Baseline at DB Week 26 |
---|
DVS SR 50 mg | 0.25 | 0.53 | 0.45 | 0.11 | 0.31 | 0.69 | 0.62 | 0.56 | 0.92 | 0.77 |
,Placebo | 0.28 | 1.40 | 1.32 | 1.50 | 1.94 | 2.37 | 2.66 | 2.51 | 3.22 | 3.12 |
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Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase
HAM-D6 is a standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM. (NCT00887224)
Timeframe: Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)
Intervention | scores on a scale (Mean) |
---|
| Change from baseline at DB Week1 | Change from baseline at DB Week 2 | Change from baseline at DB Week 3 | Change from baseline at DB Week 4 | Change from baseline at DB Week 6 | Change from baseline at DB Week 10 | Change from baseline at DB Week 14 | Change from baseline at DB Week 18 | Change from baseline at DB Week 22 | Change from baseline at DB Week 26 |
---|
DVS SR 50 mg | 0.01 | 0.13 | 0.14 | 0.03 | 0.16 | 0.33 | 0.34 | 0.21 | 0.45 | 0.26 |
,Placebo | 0.03 | 0.66 | 0.72 | 0.92 | 1.04 | 1.41 | 1.47 | 1.51 | 1.68 | 1.53 |
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Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index
WHO-5 evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions (felt cheerful, in good spirits; felt calm, relaxed; felt active, vigorous; woke up fresh, rested; and daily life filled with things that are interesting) each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score ranged from 0 (worst possible quality of life) to 25 (best possible quality of life). Change from baseline mean=adjusted mean change calculated using MMRM. (NCT00887224)
Timeframe: Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)
Intervention | scores on a scale (Mean) |
---|
| Change from baseline at DB Week 14 | Change from baseline at DB Week 26 |
---|
DVS SR 50 mg | -0.38 | -0.04 |
,Placebo | -2.51 | -2.36 |
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Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. (NCT00887224)
Timeframe: Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)
Intervention | participants (Number) |
---|
| DB Week 1: 1=very much improved | DB Week 1: 2=much improved | DB Week 1: 3=minimally improved | DB Week 1: 4=no change | DB Week 1: 5=minimally worse | DB Week 1: 6=much worse | DB Week 1: 7=very much worse | DB Week 2: 1=very much improved | DB Week 2: 2=much improved | DB Week 2: 3=minimally improved | DB Week 2: 4=no change | DB Week 2: 5=minimally worse | DB Week 2: 6=much worse | DB Week 2: 7=very much worse | DB Week 3: 1=very much improved | DB Week 3: 2=much improved | DB Week 3: 3=minimally improved | DB Week 3: 4=no change | DB Week 3: 5=minimally worse | DB Week 3: 6=much worse | DB Week 3: 7=very much worse | DB Week 4: 1=very much improved | DB Week 4: 2=much improved | DB Week 4: 3=minimally improved | DB Week 4: 4=no change | DB Week 4: 5=minimally worse | DB Week 4: 6=much worse | DB Week 4: 7=very much worse | DB Week 6: 1=very much improved | DB Week 6: 2=much improved | DB Week 6: 3=minimally improved | DB Week 6: 4=no change | DB Week 6: 5=minimally worse | DB Week 6: 6=much worse | DB Week 6: 7=very much worse | DB Week 10: 1=very much improved | DB Week 10: 2=much improved | DB Week 10: 3=minimally improved | DB Week 10: 4=no change | DB Week 10: 5=minimally worse | DB Week 10: 6=much worse | DB Week 10: 7=very much worse | DB Week 14: 1=very much improved | DB Week 14: 2=much improved | DB Week 14: 3=minimally improved | DB Week 14: 4=no change | DB Week 14: 5=minimally worse | DB Week 14: 6=much worse | DB Week 14: 7=very much worse | DB Week 18: 1=very much improved | DB Week 18: 2=much improved | DB Week 18: 3=minimally improved | DB Week 18: 4=no change | DB Week 18: 5=minimally worse | DB Week 18: 6=much worse | DB Week 18: 7=very much worse | DB Week 22: 1=very much improved | DB Week 22: 2=much improved | DB Week 22: 3=minimally improved | DB Week 22: 4=no change | DB Week 22: 5=minimally worse | DB Week 22: 6=much worse | DB Week 22: 7=very much worse | DB Week 26: 1=very much improved | DB Week 26: 2=much improved | DB Week 26: 3=minimally improved | DB Week 26: 4=no change | DB Week 26: 5=minimally worse | DB Week 26: 6=much worse | DB Week 26: 7=very much worse |
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DVS SR 50 mg | 3 | 3 | 19 | 212 | 20 | 3 | 1 | 3 | 6 | 24 | 197 | 25 | 4 | 0 | 6 | 8 | 27 | 185 | 24 | 2 | 0 | 8 | 7 | 28 | 181 | 20 | 2 | 1 | 9 | 11 | 31 | 174 | 16 | 6 | 0 | 7 | 9 | 28 | 161 | 28 | 8 | 1 | 4 | 10 | 29 | 159 | 25 | 3 | 0 | 7 | 6 | 28 | 151 | 24 | 6 | 1 | 8 | 6 | 29 | 139 | 28 | 5 | 0 | 9 | 10 | 29 | 135 | 22 | 5 | 0 |
,Placebo | 9 | 1 | 12 | 227 | 16 | 2 | 0 | 7 | 5 | 15 | 183 | 32 | 15 | 0 | 5 | 5 | 17 | 169 | 45 | 6 | 0 | 5 | 6 | 20 | 169 | 39 | 6 | 1 | 6 | 5 | 20 | 153 | 40 | 14 | 0 | 3 | 4 | 19 | 140 | 46 | 9 | 1 | 3 | 5 | 16 | 124 | 49 | 10 | 0 | 6 | 6 | 12 | 117 | 39 | 12 | 0 | 7 | 4 | 13 | 116 | 30 | 13 | 1 | 7 | 7 | 13 | 105 | 31 | 10 | 1 |
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Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase
WPAI is a 6 question participant rated questionnaire to determine the degree to which depression affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher score indicated greater impairment and less productivity. (NCT00887224)
Timeframe: Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)
Intervention | scores on a scale (Mean) |
---|
| Change from Bsl at DB Week 14: Absenteeism | Change from Bsl at DB Week 14: Presenteeism | Change from Bsl DB Week 14: Work productivity loss | Change from Bsl at DB Week 14: Activity impairment | Change from Bsl at DB Week 26: Absenteeism | Change from Bsl at DB Week 26: Presenteeism | Change from Bsl DB Week 26: Work productivity loss | Change from Bsl at DB Week 26: Activity impairment |
---|
DVS SR 50 mg | 0.62 | 2.44 | 2.19 | 3.45 | 0.77 | -0.49 | -0.00 | 2.05 |
,Placebo | 1.64 | 9.35 | 9.66 | 11.02 | 0.43 | 7.75 | 8.47 | 9.67 |
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Midazolam Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR
(NCT00952653)
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Intervention | ng*hr/mL (Geometric Mean) |
---|
Midazolam 4 mg (Period 1) | 52.85 |
DVS SR 50 mg, Midazolam 4 mg (Period 2) | 38.11 |
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Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR
Cmax measured as nanograms per milliliters (ng/mL). (NCT00952653)
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Intervention | ng/mL (Geometric Mean) |
---|
Midazolam 4 mg (Period 1) | 21.20 |
DVS SR 50 mg, Midazolam 4 mg (Period 2) | 18.24 |
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Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR
AUCinf measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL). (NCT00952653)
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Intervention | ng*hr/mL (Geometric Mean) |
---|
Midazolam 4 mg (Period 1) | 54.69 |
DVS SR 50 mg, Midazolam 4 mg (Period 2) | 39.45 |
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1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR
(NCT00952653)
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Intervention | hr (Median) |
---|
Midazolam 4 mg (Period 1) | 1.00 |
DVS SR 50 mg, Midazolam 4 mg (Period 2) | 0.500 |
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1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR
(NCT00952653)
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Intervention | hr (Mean) |
---|
Midazolam 4 mg (Period 1) | 5.396 |
DVS SR 50 mg, Midazolam 4 mg (Period 2) | 4.616 |
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1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR
(NCT00952653)
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Intervention | ng/mL (Geometric Mean) |
---|
Midazolam 4 mg (Period 1) | 14.93 |
DVS SR 50 mg, Midazolam 4 mg (Period 2) | 15.10 |
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1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR
(NCT00952653)
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Intervention | ng*hr/mL (Geometric Mean) |
---|
Midazolam 4 mg (Period 1) | 37.09 |
DVS SR 50 mg, Midazolam 4 mg (Period 2) | 32.42 |
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1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR
1-Hydroxy-Midazolam is an analyte of Midazolam. (NCT00952653)
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Intervention | ng*hr/mL (Geometric Mean) |
---|
Midazolam 4 mg (Period 1) | 36.87 |
DVS SR 50 mg, Midazolam 4 mg (Period 2) | 30.74 |
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Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR
(NCT00952653)
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Intervention | hr (Mean) |
---|
Midazolam 4 mg (Period 1) | 5.320 |
DVS SR 50 mg, Midazolam 4 mg (Period 2) | 4.648 |
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Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR
(NCT00952653)
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Intervention | hr (Median) |
---|
Midazolam 4 mg (Period 1) | 0.517 |
DVS SR 50 mg, Midazolam 4 mg (Period 2) | 0.500 |
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Percentage of Participants Who Were Unable to Successfully Complete Tapering of the Study Drug Because of the Number and/or Severity of Their Discontinuation Symptoms
Discontinuation symptoms may occur following abrupt cessation of serotonergic antidepressants in a minority of participants following short-term treatment of an episode of Major Depressive Disorder (MDD). The symptoms include emotional and somatic symptoms such as dizziness, nausea, and paresthesia and typically appear within 2 to 3 days of reducing the dose or stopping the antidepressant medication. Discontinuation symptoms are usually mild and resolve spontaneously within a week in the majority of patients, though a minority can have intense and prolonged symptoms. (NCT01056289)
Timeframe: Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)
Intervention | percentage of participants (Number) |
---|
DVS SR 50 mg | 1.4 |
DVS SR 25 mg (Double-blind Phase) | 1.4 |
Placebo | 1.4 |
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Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase
Any untoward medical occurrence in a patient who received study drug was considered an AE without regard to possibility of causal relationship. Taper-emergent AEs (TPAEs) are those events which occurred during the double-blind period but did not occur during the last 7 days of the on-therapy period or existed during the last 7 days and worsened in the double-blind period. (NCT01056289)
Timeframe: Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)
Intervention | percentage of participants (Number) |
---|
DVS SR 50 mg | 35.6 |
DVS SR 25 mg | 38.6 |
Placebo | 50.7 |
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Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase
Clinician-administered 43-item assessment to evaluate discontinuation-emergent symptoms resulting from withdrawal from study treatment. Total score=sum of number of new symptoms and old (but worse) symptoms (score=1) and old and unchanged symptom, absent, or old symptom but improved (score=0); total possible range 0 to 43. Higher score=more symptoms. New symptom=any symptom that appeared within 7 days before DESS administration; old symptom=any symptom that appeared 7 days before DESS administration and continued into 7-day period. DESS calculated as 2*mean(of DESSDB Week 1, DESSDB Week 2). (NCT01056289)
Timeframe: Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182)
Intervention | scores on a scale (Mean) |
---|
DVS SR 50 mg | 4.1 |
DVS SR 25 mg | 4.8 |
Placebo | 5.3 |
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Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
CGI-I: 7-point scale in which the clinician rated how much the participant's condition has changed compared to baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. (NCT01121484)
Timeframe: Week 8
Intervention | participants (Number) |
---|
| Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse |
---|
Desvenlafaxine Succinate | 51 | 67 | 53 | 37 | 6 | 2 | 0 |
,Placebo | 39 | 37 | 62 | 69 | 6 | 3 | 0 |
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Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. (NCT01121484)
Timeframe: Baseline, Week 8
Intervention | Units on a scale (Mean) |
---|
| Baseline | Change at Week 8 |
---|
Desvenlafaxine Succinate | 4.4 | -1.5 |
,Placebo | 4.3 | -1.1 |
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Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8
10 centimeter (cm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 10 = worst possible pain. Change: score at observation minus score at baseline. (NCT01121484)
Timeframe: Baseline, Week 8
Intervention | cm (Mean) |
---|
| Baseline | Change at Week 8 |
---|
Desvenlafaxine Succinate | 4.0 | -1.5 |
,Placebo | 4.0 | -0.8 |
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Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)
This is a 16-item self reported questionnaire that measures depressive symptoms. Improvement reported as change in depressive score. Score ranges from 0 to 42, with higher numbers indicating more severe symptom reporting. Change: score at observation minus score at baseline. (NCT01121484)
Timeframe: Baseline, Week 8
Intervention | Units on a scale (Mean) |
---|
| Baseline | Change at Week 8 |
---|
Desvenlafaxine Succinate | 15.1 | -5.9 |
,Placebo | 14.8 | -5.2 |
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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: score at observation minus score at baseline. (NCT01121484)
Timeframe: Baseline, Week 8
Intervention | Units on a scale (Mean) |
---|
| Baseline | Change at Week 8 |
---|
Desvenlafaxine Succinate | 31.0 | -14.8 |
,Placebo | 30.6 | -11.6 |
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Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8
HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline: score at observation minus score at baseline. (NCT01121484)
Timeframe: Baseline, Week 8
Intervention | Units on a scale (Mean) |
---|
| Baseline | Change at Week 8 |
---|
Desvenlafaxine Succinate | 22.8 | -9.7 |
,Placebo | 22.4 | -7.4 |
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Aripiprazole Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR
Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant. (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Intervention | liters (Geometric Mean) |
---|
Aripiprazole 5 mg (Period 1) | 397.3 |
Aripiprazole 5 mg + DVS SR 100 mg (Period 2) | 368.1 |
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Plasma Aripiprazole Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg + Aripiprazole 5 mg
Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0. (NCT01188668)
Timeframe: Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing
Intervention | ng/mL (Median) |
---|
| 0 hour | 0.5 hour post dose | 1 hour post dose | 2 hours post dose | 3 hours post dose | 4 hours post dose | 6 hours post dose | 8 hours post dose | 12 hours post dose | 16 hours post dose | 24 hours post dose | 48 hours post dose | 72 hours post dose | 120 hours post dose | 168 hours post dose | 216 hours post dose | 264 hours post dose | 312 hours post dose |
---|
Aripiprazole 5 mg (Period 1) | NA | 0.4800 | 10.69 | 23.40 | 21.75 | 21.35 | 18.95 | 16.65 | 13.65 | 11.50 | 10.70 | 8.310 | 6.255 | 3.680 | 2.390 | 1.730 | 1.080 | 0.8040 |
,Aripiprazole 5 mg + DVS SR 100 mg (Period 2) | 0.1290 | 1.220 | 9.545 | 21.70 | 24.40 | 25.40 | 20.70 | 18.00 | 13.80 | 12.50 | 12.20 | 8.940 | 6.870 | 4.000 | 2.720 | 1.960 | 1.340 | 1.010 |
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Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR
Cmax measured as nanograms per milliliters (ng/mL). (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Intervention | ng/mL (Geometric Mean) |
---|
Aripiprazole 5 mg (Period 1) | 24.66 |
Aripiprazole 5 mg + DVS SR 100 mg (Period 2) | 24.69 |
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Aripiprazole Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min). (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Intervention | mL/min (Geometric Mean) |
---|
Aripiprazole 5 mg (Period 1) | 55.76 |
Aripiprazole 5 mg + DVS SR 100 mg (Period 2) | 51.92 |
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Aripiprazole Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR
Time for maximum observed plasma concentration. (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Intervention | hours (Median) |
---|
Aripiprazole 5 mg (Period 1) | 3.00 |
Aripiprazole 5 mg + DVS SR 100 mg (Period 2) | 4.00 |
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Aripiprazole Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR
Terminal half-life is the time measured for the plasma concentration to decrease by one half. (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Intervention | hours (Mean) |
---|
Aripiprazole 5 mg (Period 1) | 85.17 |
Aripiprazole 5 mg + DVS SR 100 mg (Period 2) | 84.18 |
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Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL). (NCT01188668)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Intervention | ng*hr/mL (Geometric Mean) |
---|
Aripiprazole 5 mg (Period 1) | 1494 |
Aripiprazole 5 mg + DVS SR 100 mg (Period 2) | 1604 |
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Tamoxifen Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL). (NCT01189500)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.
Intervention | ng*hr/mL (Geometric Mean) |
---|
Tamoxifen 40 mg (Period 1) | 5751 |
Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 5888 |
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Tamoxifen Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR
Cmax measured as nanograms per milliliters (ng/mL). (NCT01189500)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.
Intervention | ng/mL (Geometric Mean) |
---|
Tamoxifen 40 mg (Period 1) | 70.58 |
Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 70.33 |
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Tamoxifen Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR
Terminal half-life is the time measured for the plasma concentration to decrease by one half. (NCT01189500)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.
Intervention | hours (Mean) |
---|
Tamoxifen 40 mg (Period 1) | 250.5 |
Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 242.3 |
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Tamoxifen Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR
Time for maximum observed plasma concentration. (NCT01189500)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.
Intervention | hours (Median) |
---|
Tamoxifen 40 mg (Period 1) | 4.00 |
Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 4.00 |
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Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR
Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.250 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0. (NCT01189500)
Timeframe: Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing
Intervention | ng/mL (Median) |
---|
| 0 hour | 0.5 hour post dose | 1 hour post dose | 2 hours post dose | 3 hours post dose | 4 hours post dose | 6 hours post dose | 8 hours post dose | 12 hours post dose | 16 hours post dose | 24 hours post dose | 48 hours post dose | 72 hours post dose | 120 hours post dose | 168 hours post dose | 216 hours post dose | 264 hours post dose | 312 hours post dose | 384 hours post dose | 456 hours post dose | 528 hours post dose |
---|
Tamoxifen 40 mg (Period 1) | NA | 1.875 | 11.45 | 37.20 | 54.50 | 68.25 | 58.95 | 54.75 | 40.40 | 27.30 | 24.50 | 15.40 | 12.55 | 10.55 | 9.120 | 7.555 | 7.575 | 6.445 | 5.180 | 4.300 | 3.560 |
,Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 1.300 | 4.650 | 13.90 | 33.60 | 55.60 | 72.20 | 60.90 | 56.10 | 35.30 | 26.20 | 25.50 | 16.20 | 12.60 | 11.60 | 9.930 | 8.150 | 7.270 | 6.920 | 5.600 | 4.330 | 4.160 |
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Tamoxifen Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min). (NCT01189500)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.
Intervention | mL/min (Geometric Mean) |
---|
Tamoxifen 40 mg (Period 1) | 115.9 |
Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 113.2 |
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Tamoxifen Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR
Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant. (NCT01189500)
Timeframe: Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.
Intervention | liters (Geometric Mean) |
---|
Tamoxifen 40 mg (Period 1) | 2474 |
Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 2321 |
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
(NCT01190514)
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Intervention | hours (Median) |
---|
DVS SR 25 mg*2 Fed | 6.00 |
DVS SR 50 mg Fed | 8.00 |
DVS SR 25 mg*2 Fasted | 6.00 |
DVS SR 50 mg Fasted | 6.00 |
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Terminal Elimination Half-life (t 1/2)
Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half. (NCT01190514)
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Intervention | hours (Mean) |
---|
DVS SR 25 mg*2 Fed | 10.50 |
DVS SR 50 mg Fed | 10.72 |
DVS SR 25 mg*2 Fasted | 12.71 |
DVS SR 50 mg Fasted | 11.13 |
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Maximum Plasma Concentration (Cmax)
Cmax measured as nanograms divided by milliliters (ng/mL). (NCT01190514)
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Intervention | ng/mL (Mean) |
---|
DVS SR 25 mg*2 Fed | 130.6 |
DVS SR 50 mg Fed | 131.0 |
DVS SR 25 mg*2 Fasted | 107.3 |
DVS SR 50 mg Fasted | 112.1 |
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Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)
Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL). (NCT01190514)
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Intervention | ng*hr/mL (Mean) |
---|
DVS SR 25 mg*2 Fed | 2948 |
DVS SR 50 mg Fed | 2966 |
DVS SR 25 mg*2 Fasted | 2632 |
DVS SR 50 mg Fasted | 2777 |
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Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast)
(NCT01190514)
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Intervention | ng*hr/mL (Mean) |
---|
DVS SR 25 mg*2 Fed | 2948 |
DVS SR 50 mg Fed | 2966 |
DVS SR 25 mg*2 Fasted | 2631 |
DVS SR 50 mg Fasted | 2778 |
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Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). (NCT01190514)
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Intervention | ng*hr/mL (Mean) |
---|
DVS SR 25 mg*2 Fed | 3171 |
DVS SR 50 mg Fed | 3216 |
DVS SR 25 mg*2 Fasted | 3008 |
DVS SR 50 mg Fasted | 3052 |
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Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score
Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms. (NCT01316302)
Timeframe: Baseline to study endpoint (Week 12)
Intervention | Scores on a scale (Mean) |
---|
| Mean baseline LSAS total | Endpoint LSAS total | Mean LSAS change from baseline |
---|
Placebo | 92.1 | 63.4 | 28.7 |
,Pristiq | 93.4 | 55.0 | 38.4 |
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Clinical Global Impression of Improvement Scale (CGI-I)
CGI-I: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement. CGI-I responders: defined as having a CGI-I scores of 1 or 2 at Week 12/study endpoint. (NCT01316302)
Timeframe: Baseline to Week 12
Intervention | % of subjects who were CGI-I responders (Number) |
---|
Pristiq | 69 |
Placebo | 48.3 |
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Patient Global Impression of Change
Subject-rated global outcome scale. Subjects who rated themselves as 1 (Very Much Improved) or 2 (Much Improved) on the PGIC were considered self-rated responders. (NCT01316302)
Timeframe: Baseline to study endpoint (Week 12)
Intervention | percentage of self-rated responders (Number) |
---|
Pristiq | 44.8 |
Placebo | 40.7 |
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Change From Baseline in Weight at Week 8.
(NCT01353963)
Timeframe: Week 8
Intervention | kg (Mean) |
---|
Desvenlafaxine Succinate | 0.5 |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug with regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between Week 4 and up to Week 8 that were absent before treatment or that worsened relative to pretreatment state. (NCT01353963)
Timeframe: Week 4 to Week 8
Intervention | Participants (Number) |
---|
| Participants w ith AEs | Participants w ith SAEs | Participants discontinued due to AEs |
---|
Desvenlafaxine Succinate | 5 | 0 | 2 |
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Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.
(NCT01353963)
Timeframe: Week 8
Intervention | millimeter of mercury (mmHg) (Mean) |
---|
| Change from baseline in systolic BP at Week 8 | Change from baseline in diastolic BP at Week 8 |
---|
Desvenlafaxine Succinate | -0.7 | -1.8 |
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Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.
(NCT01353963)
Timeframe: Week 4
Intervention | millimeter of mercury (mmHg) (Mean) |
---|
| Change from baseline in systolic BP at Week 4 | Change from baseline in diastolic BP at Week 4 |
---|
Desvenlafaxine Succinate | -0.5 | -0.5 |
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Change From Baseline in Weight at Week 4.
(NCT01353963)
Timeframe: Week 4
Intervention | kilogram (kg) (Mean) |
---|
Desvenlafaxine Succinate | 0.1 |
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Change From Baseline in Heart Rate at Week 8.
(NCT01353963)
Timeframe: Week 8
Intervention | bpm (Mean) |
---|
Desvenlafaxine Succinate | 0.6 |
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Change From Baseline in Heart Rate at Week 4.
(NCT01353963)
Timeframe: Week 4
Intervention | beats per minute (bpm) (Mean) |
---|
Desvenlafaxine Succinate | 1.9 |
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Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score equals (=) more affected. (NCT01371734)
Timeframe: Weeks 1, 2, 3, 4, 6, and 8
Intervention | Percentage of Participants (Number) |
---|
| Week 1, Very Much Improved (n=113, 112,115) | Week 1, Much Improved (n=113, 112, 115) | Week 1, Minimally Improved (n=113, 112, 115) | Week 1, No Change (n=113, 112, 115) | Week 1, Minimally Worse (n=113, 112, 115) | Week 1, Much Worse (n=113, 112, 115) | Week 1, Very Much Worse (n=113, 112, 115) | Week 2, Very Much Improved (n=114, 115, 109) | Week 2, Much Improved (n=114, 115, 109) | Week 2, Minimally Improved (n=114, 115, 109) | Week 2, No Change (n=114, 115, 109) | Week 2, Minimally Worse (n=114, 115, 109) | Week 2, Much Worse (n=114, 115, 109) | Week 2, Very Much Worse (n=114, 115, 109) | Week 3, Very Much Improved (n=108, 110, 110) | Week 3, Much Improved (n=108, 110, 110) | Week 3, Minimally Improved (n=108, 110, 110) | Week 3, No Change (n=108, 110, 110) | Week 3, Minimally Worse (n=108, 110, 110) | Week 3, Much Worse (n=108, 110, 110) | Week 3, Very Much Worse (n=108, 110, 110) | Week 4, Very Much Improved (n=104,108,113) | Week 4, Much Improved (n=104,108,113) | Week 4, Minimally Improved (n=104,108,113) | Week 4, No Change (n=104,108,113) | Week 4, Minimally Worse (n=104,108,113) | Week 4, Much Worse (n=104,108,113) | Week 4, Very Much Worse (n=104,108,113) | Week 6, Very Much Improved (n=106,104,104) | Week 6, Much Improved (n=106,104,104) | Week 6, Minimally Improved (n=106,104,104) | Week 6, No Change (n=106,104,104) | Week 6, Minimally Worse (n=106,104,104) | Week 6, Much Worse (n=106,104,104) | Week 6, Very Much Worse (n=106,104,104) | Week 8, Very Much Improved (n=102,105,106) | Week 8, Much Improved (n=102,105,106) | Week 8, Minimally Improved (n=102,105,106) | Week 8, No Change (n=102,105,106) | Week 8, Minimally Worse (n=102,105,106) | Week 8, Much Worse (n=102,105,106) | Week 8, Very Much Worse (n=102,105,106) |
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DVS SR High Dose | 2.6 | 12.2 | 33.9 | 46.1 | 5.2 | 0 | 0 | 10.1 | 23.9 | 35.8 | 29.4 | 0 | 0.9 | 0 | 18.2 | 24.5 | 35.5 | 21.8 | 0 | 0 | 0 | 15.0 | 31.0 | 35.4 | 17.7 | 0.9 | 0 | 0 | 26.9 | 24.0 | 31.7 | 14.4 | 1.9 | 1.0 | 0 | 25.5 | 36.8 | 21.7 | 15.1 | 0.9 | 0 | 0 |
,DVS SR Low Dose | 0.9 | 9.8 | 37.5 | 51.8 | 0 | 0 | 0 | 6.1 | 26.1 | 38.3 | 25.2 | 4.3 | 0 | 0 | 10.9 | 26.4 | 44.5 | 15.5 | 1.8 | 0 | 0.9 | 17.6 | 36.1 | 30.6 | 14.8 | 0.9 | 0 | 0 | 20.2 | 36.5 | 24.0 | 14.4 | 2.9 | 1.9 | 0 | 19.0 | 37.1 | 24.8 | 18.1 | 1.0 | 0 | 0 |
,Placebo | 2.7 | 6.2 | 38.9 | 49.6 | 2.7 | 0 | 0 | 4.4 | 26.3 | 36.8 | 31.6 | 0 | 0.9 | 0 | 10.2 | 20.4 | 47.2 | 20.4 | 1.9 | 0 | 0 | 14.4 | 30.8 | 35.6 | 19.2 | 0 | 0 | 0 | 19.8 | 29.2 | 31.1 | 16.0 | 2.8 | 0 | 0.9 | 21.6 | 34.3 | 28.4 | 15.7 | 0 | 0 | 0 |
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Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. Higher score = more affected. (NCT01371734)
Timeframe: Weeks 1, 2, 3, 4, 6, and 8
Intervention | Percentage of Participants (Number) |
---|
| Week 1 (n=113, 112, 115) | Week 2 (n=114, 115, 109) | Week 3 (n=108, 110, 110) | Week 4 (n=104, 108, 113) | Week 6 (n=106, 104, 104) | Week 8 (n=102, 105, 106) |
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DVS SR High Dose | 14.78 | 33.94 | 42.73 | 46.02 | 50.96 | 62.26 |
,DVS SR Low Dose | 10.71 | 32.17 | 37.27 | 53.70 | 56.73 | 56.19 |
,Placebo | 8.85 | 30.70 | 30.56 | 45.19 | 49.06 | 55.88 |
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Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Mean change from baseline was adjusted for the baseline total score, age group and gender. (NCT01371734)
Timeframe: Baseline and Week 8
Intervention | Score on a scale (Least Squares Mean) |
---|
Placebo | -22.85 |
DVS SR Low Dose | -23.70 |
DVS SR High Dose | -24.37 |
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Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)
A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Mean change from baseline was adjusted for the baseline total score, age group and gender. (NCT01371734)
Timeframe: Baseline and Week 8
Intervention | Score on a scale (Least Squares Mean) |
---|
Placebo | -1.49 |
DVS SR Low Dose | -1.51 |
DVS SR High Dose | -1.65 |
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Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. (NCT01372150)
Timeframe: Weeks 1, 2, 3, 4, 6, and 8
Intervention | Percentage of Participants (Number) |
---|
| Week 1 (n=102, 101, 111) | Week 2 (n=103, 105, 110) | Week 3 (n=105, 102, 107) | Week 4 (n=101, 101, 100) | Week 6 (n=100, 100, 102) | Week 8 (n=99, 101, 99) |
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DVS SR | 9.01 | 35.45 | 49.53 | 64.00 | 68.63 | 68.69 |
,Fluoxetine | 14.85 | 33.33 | 50.98 | 61.39 | 71.00 | 78.22 |
,Placebo | 8.82 | 29.13 | 42.86 | 54.46 | 59.00 | 62.63 |
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Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. (NCT01372150)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 6, and 8
Intervention | Percentage of Participants (Number) |
---|
| Week 1, Very Much Improved (n=102, 101, 111) | Week 1, Much Improved (n=102, 101, 111) | Week 1, Minimally Improved (n=102, 101, 111) | Week 1, No Change (n=102, 101, 111) | Week 1, Minimally Worse (n=102, 101, 111) | Week 1, Much Worse (n=102, 101, 111) | Week 1, Very Much Worse (n=102, 101, 111) | Week 2, Very Much Improved (n=103, 105, 110) | Week 2, Much Improved (n=103, 105, 110) | Week 2, Minimally Improved (n=103, 105, 110) | Week 2, No Change (n=103, 105, 110) | Week 2, Minimally Worse (n=103, 105, 110) | Week 2, Much Worse (n=103, 105, 110) | Week 2, Very Much Worse (n=103, 105, 110) | Week 3, Very Much Improved (n=105, 102, 107) | Week 3, Much Improved (n=105, 102, 107) | Week 3, Minimally Improved (n=105, 102, 107) | Week 3, No Change (n=105, 102, 107) | Week 3, Minimally Worse (n=105, 102, 107) | Week 3, Much Worse (n=105, 102, 107) | Week 3, Very Much Worse (n=105, 102, 107) | Week 4, Very Much Improved (n=101, 101, 100) | Week 4, Much Improved (n=101, 101, 100) | Week 4, Minimally Improved (n=101, 101, 100) | Week 4, No Change (n=101, 101, 100) | Week 4, Minimally Worse (n=101, 101, 100) | Week 4, Much Worse (n=101, 101, 100) | Week 4, Very Much Worse (n=101, 101, 100) | Week 6, Very Much Improved (n=100, 100, 102) | Week 6, Much Improved (n=100, 100, 102) | Week 6, Minimally Improved (n=100, 100, 102) | Week 6, No Change (n=100, 100, 102) | Week 6, Minimally Worse (n=100, 100, 102) | Week 6, Much Worse (n=100, 100, 102) | Week 6, Very Much Worse (n=100, 100, 102) | Week 8, Very Much Improved (n=99, 101, 99) | Week 8, Much Improved (n=99, 101, 99) | Week 8, Minimally Improved (n=99, 101, 99) | Week 8, No Change (n=99, 101, 99) | Week 8, Minimally Worse (n=99, 101, 99) | Week 8, Much Worse (n=99, 101, 99) | Week 8, Very Much Worse (n=99, 101, 99) |
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DVS SR | 2.7 | 6.3 | 43.2 | 45.9 | 1.8 | 0 | 0 | 3.6 | 31.8 | 44.5 | 19.1 | 0.9 | 0 | 0 | 7.5 | 42.1 | 38.3 | 11.2 | 0.9 | 0 | 0 | 20.0 | 44.0 | 25.0 | 10.0 | 1.0 | 0 | 0 | 23.5 | 45.1 | 20.6 | 9.8 | 1.0 | 0 | 0 | 23.2 | 45.5 | 21.2 | 9.1 | 1.0 | 0 | 0 |
,Fluoxetine | 3.0 | 11.9 | 35.6 | 47.5 | 2.0 | 0 | 0 | 6.7 | 26.7 | 42.9 | 22.9 | 1.0 | 0 | 0 | 14.7 | 36.3 | 36.3 | 11.8 | 1.0 | 0 | 0 | 13.9 | 47.5 | 27.7 | 9.9 | 1.0 | 0 | 0 | 26.0 | 45.0 | 24.0 | 5.0 | 0 | 0 | 0 | 30.7 | 47.5 | 16.8 | 4.0 | 1.0 | 0 | 0 |
,Placebo | 1.0 | 7.8 | 46.1 | 43.1 | 2.0 | 0 | 0 | 3.9 | 25.2 | 38.8 | 30.1 | 1.9 | 0 | 0 | 13.3 | 29.5 | 41.0 | 15.2 | 1.0 | 0 | 0 | 15.8 | 38.6 | 29.7 | 13.9 | 2.0 | 0 | 0 | 18.0 | 41.0 | 34.0 | 6.0 | 0 | 1.0 | 0 | 27.3 | 35.4 | 32.3 | 4.0 | 1.0 | 0 | 0 |
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Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented. (NCT01372150)
Timeframe: Baseline and Week 8
Intervention | Score on a Scale (Mean) |
---|
Placebo | -23.07 |
Fluoxetine | -24.79 |
DVS SR | -22.61 |
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Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score
A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented. (NCT01372150)
Timeframe: Baseline and Week 8
Intervention | Score on a Scale (Mean) |
---|
Placebo | -1.71 |
Fluoxetine | -1.88 |
DVS SR | -1.70 |
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Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score
"The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated.~Each individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function." (NCT01432457)
Timeframe: Baseline to Week 8 (final on-therapy)
Intervention | Units on a scale (Mean) |
---|
Placebo | -0.45 |
DVS SR 50 mg | -0.35 |
DVS SR 100 mg | -0.13 |
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Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state. (NCT01432457)
Timeframe: Baseline to Week 8 (final on-therapy)
Intervention | Units on scale (Mean) |
---|
Placebo | -1.21 |
DVS SR 50 mg | -1.38 |
DVS SR 100 mg | -1.43 |
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Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state. (NCT01432457)
Timeframe: Baseline to Week 8 (final on-therapy)
Intervention | Units on scale (Mean) |
---|
Placebo | -1.27 |
DVS SR 50 mg | -1.47 |
DVS SR 100 mg | -1.55 |
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Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline (NCT01432457)
Timeframe: Baseline to Week 8 (final on-therapy)
Intervention | Units on a scale (Mean) |
---|
Placebo | -9.50 |
DVS SR 50 mg | -10.86 |
DVS SR 100 mg | -11.16 |
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Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline. (NCT01432457)
Timeframe: Baseline to Week 8 (final on-therapy)
Intervention | Units on a scale (Mean) |
---|
Placebo | -9.71 |
DVS SR 50 mg | -11.28 |
DVS SR 100 mg | -11.67 |
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Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7. (NCT01432457)
Timeframe: Baseline to week 8 (final on-therapy)
Intervention | percentage of the number of participants (Number) |
---|
Placebo | 21.77 |
DVS SR 50 mg | 24.05 |
DVS SR 100 mg | 28.57 |
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Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score. (NCT01432457)
Timeframe: Baseline to Week 8 (final on-therapy)
Intervention | percentage of the number of participants (Number) |
---|
Placebo | 39.46 |
DVS SR 50 mg | 45.02 |
DVS SR 100 mg | 47.51 |
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Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome. (NCT01432457)
Timeframe: Baseline to Week 8 (final on-therapy)
Intervention | number of participants (Number) |
---|
| 1=Very much improved | 2=Much improved | 3=Minimally improved | 4=No change | 5=Minimally worse | 6=Much worse | 7=Very much worse |
---|
DVS SR 100 mg | 81 | 98 | 69 | 49 | 4 | 0 | 0 |
,DVS SR 50 mg | 57 | 104 | 79 | 48 | 3 | 0 | 0 |
,Placebo | 55 | 76 | 83 | 73 | 7 | 0 | 0 |
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Response Rate
Assessment of overall improvement: based on HDRS and Clinical Global Improvement Scale Response Rate is defined as 50% improvement of Hamd24 summary scores from baseline. (NCT01537068)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|
Desvenlafaxine | 16 |
Placebo | 7 |
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Hamilton Rating Scale for Depression (HDRS24)
HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression (NCT01537068)
Timeframe: Baseline
Intervention | units on a scale (Mean) |
---|
Desvenlafaxine | 14.63 |
Placebo | 14.21 |
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Hamilton Rating Scale for Depression (HDRS24)
HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression (NCT01537068)
Timeframe: Week 12
Intervention | units on a scale (Mean) |
---|
Desvenlafaxine | 6.53 |
Placebo | 8.24 |
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Money Earned
"Change in amount of money earned between baseline and after 6 weeks of antidepressant treatment is determined through a summary score from a variety of decision-making tasks. Participants received between $5 and $40 per visit, depending on the outcomes of the decisions made on the computerized tasks. Variable payment ensured that the decision-making tasks were approached realistically, as opposed to using hypothetical points that do not have meaning in the real world. Greater earnings indicate better financial decision-making.~The specific tasks were:~risk task~balloon analogue risk task~temporal discounting task~ultimatum game~continuous performance task" (NCT01916824)
Timeframe: Baseline, Week 6
Intervention | US Dollars (Mean) |
---|
| Baseline Visit | After 6 Weeks of Treatment |
---|
Healthy Controls | 25.0 | 21.9 |
,Participants With Major Depressive Disorder | 23.2 | 20.5 |
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Change From Baseline in Depressive Symptoms at Day 15, as Assessed by PHQ-9
The PHQ-9 is a participant-rated depressive symptom severity scale. The PHQ-9 total score is calculated as the sum of the 9 individual item scores. For individual items, scoring is based on responses to specific questions, as follows: 0 = not at all; 1 = several days; 2 = more than half the days; and 3 = nearly every day. The PHQ-9 possible total score range is 0 to 27, with higher scores reflecting greater depressive symptoms, and is categorized as follows: 0 to 4 = minimal depression, 5 to 9 = mild depression, 10 to 14 = moderate depression, 15 to 19 = moderately severe depression, and 20 to 27 = severe depression. Negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline and Day 15
Intervention | score on a scale (Least Squares Mean) |
---|
Placebo + Assigned ADT | -8.7 |
SAGE-217 + Assigned ADT | -8.9 |
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Change From Baseline in CGI-S Score at Day 15
The CGI-S uses a 7-point Likert scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. Considering total clinical experience, the investigator rated the participant on severity of mental illness at the time of rating as: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = extremely ill. A higher score indicated extreme illness. A negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline and Day 15
Intervention | score on a scale (Least Squares Mean) |
---|
Active Comparator: Placebo + Assigned ADT | -1.7 |
Experimental: SAGE-217 + Assigned ADT | -1.9 |
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Change From Baseline in HAM-A Total Score at Day 15
Each of the 14 items in the HAM-A was defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints). The HAM-A total score was calculated as sum of the 14 individual item scores, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The total score (sum of all individual items) range from 0 to 56, where <17 indicated mild severity, 18 to 24 indicated mild to moderate severity, and 25 to 30 indicated moderate to severe severity. Higher scores indicated more severe disease. Negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline, Day 15
Intervention | score on a scale (Least Squares Mean) |
---|
Placebo + Assigned ADT | -9.0 |
SAGE-217 + Assigned ADT | -9.5 |
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Percentage of Participants With HAMD-17 Remission at Day 15 and Day 42
HAM-D remission was defined as having a HAM-D total score of ≤7. The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. Percentages were rounded off to the first decimal point. (NCT04476030)
Timeframe: Days 15 and 42
Intervention | percentage of participants (Number) |
---|
| Day 15 | Day 42 |
---|
Placebo + Assigned ADT | 21.8 | 39.2 |
,SAGE-217 + Assigned ADT | 29.1 | 37.9 |
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Percentage of Participants With CGI-I Response, at Day 3 and Day 15
"CGI-I response was defined as having a CGI-I score of very much improved or much improved. The CGI-I employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to IP. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. By definition, all CGI-I assessments are evaluated against baseline conditions. Higher scores indicated worse condition. Percentages were rounded off to the first decimal point." (NCT04476030)
Timeframe: Days 3 and 15
Intervention | percentage of participants (Number) |
---|
| Day 3 | Day 15 |
---|
Placebo + Assigned ADT | 12.9 | 54.3 |
,SAGE-217 + Assigned ADT | 22.9 | 56.6 |
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Change From Baseline in the HAMD-17 Total Score at Days 15 and 42
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. A negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. The missing values were imputed for the analysis. (NCT04476030)
Timeframe: Baseline, Days 15 and 42
Intervention | score on a scale (Least Squares Mean) |
---|
| Day 15 | Day 42 |
---|
Placebo + Assigned ADT | -12.9 | -14.9 |
,SAGE-217 + Assigned ADT | -13.7 | -14.9 |
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE was defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. (NCT04476030)
Timeframe: Up to approximately 58 weeks
Intervention | percentage of participants (Number) |
---|
Placebo + Assigned ADT | 65.6 |
SAGE-217 + Assigned ADT | 74.1 |
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Percentage of Participants With TEAEs, Graded by Severity
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE was defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. The severity was graded as mild, moderate and severe. (NCT04476030)
Timeframe: Up to approximately 58 weeks
Intervention | percentage of participants (Number) |
---|
| Mild | Moderate | Severe |
---|
Placebo + Assigned ADT | 38.1 | 25.2 | 2.3 |
,SAGE-217 + Assigned ADT | 35.8 | 34.4 | 3.8 |
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Percentage of Participants With HAMD-17 Response at Day 15 and Day 42
HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. Percentages were rounded off to the first decimal point. (NCT04476030)
Timeframe: At Days 15 and 42
Intervention | percentage of participants (Number) |
---|
| Day 15 | Day 42 |
---|
Placebo + Assigned ADT | 49.2 | 65.3 |
,SAGE-217 + Assigned ADT | 53.4 | 59.9 |
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Time to First HAMD-17 Response
HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. Time (in days) from first dose of study drug to time of first HAMD response was reported in this outcome measure. (NCT04476030)
Timeframe: From first dose of study drug up to first HAMD-17 response (up to approximately 65 days)
Intervention | days (Median) |
---|
Placebo + Assigned ADT | 15 |
SAGE-217 + Assigned ADT | 13 |
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Percentage of Participants With MADRS Response at Day 15
MADRS response was defined as having a 50% or greater reduction from baseline in MADRS total score. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS total score was calculated as the sum of the 10 individual item scores. Each item yields a score of 0 (no symptoms) to 6 (symptoms of maximum severity). The total MADRS score (sum of all individual items) ranges from 0 (symptoms absent) to 60 (severe depression). Higher MADRS scores indicated more severe depression. Percentages were rounded off to the first decimal point. (NCT04476030)
Timeframe: Day 15
Intervention | percentage of participants (Number) |
---|
Placebo + Assigned ADT | 48.2 |
SAGE-217 + Assigned ADT | 51.6 |
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Percentage of Participants With MADRS Remission at Day 15
MADRS remission was defined as having a MADRS total score of ≤10. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS total score was calculated as the sum of the 10 individual item scores. Each item yields a score of 0 (no symptoms) to 6 (symptoms of maximum severity). The total MADRS score (sum of all individual items) ranges from 0 (symptoms absent) to 60 (severe depression). Higher MADRS scores indicated more severe depression. Percentages were rounded off to the first decimal point. (NCT04476030)
Timeframe: Day 15
Intervention | percentage of participants (Number) |
---|
Placebo + Assigned ADT | 28.4 |
SAGE-217 + Assigned ADT | 30.9 |
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Change From Baseline in the HAMD-17 Total Score at Day 3
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. A negative change from baseline indicated improvement. Least Squares (LS) mean was estimated using mixed effects model for repeated measures (MMRM) analysis. (NCT04476030)
Timeframe: Baseline, Day 3
Intervention | score on a scale (Least Squares Mean) |
---|
Placebo + Assigned ADT | -7.0 |
SAGE-217 + Assigned ADT | -8.9 |
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Change From Baseline in the HAMD-17 Total Score Around End of Blinded Treatment
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. A negative change from baseline indicated improvement. End of blinded treatment was defined as the average of change from baseline values of Days 12, 15 and 18. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline, End of blinded treatment assessment (i.e., average of Days 12, 15 , and 18)
Intervention | score on a scale (Least Squares Mean) |
---|
Placebo + Assigned ADT | -12.7 |
SAGE-217 + Assigned ADT | -13.2 |
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Change From Baseline in MADRS Total Score at Day 15
The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS total score was calculated as the sum of the 10 individual item scores. Each item yields a score of 0 (no symptoms) to 6 (symptoms of maximum severity). The total MADRS score (sum of all individual items) ranges from 0 (symptoms absent) to 60 (severe depression). Higher MADRS scores indicated more severe depression. A negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline and Day 15
Intervention | score on a scale (Least Squares Mean) |
---|
Placebo + Assigned ADT | -15.9 |
SAGE-217 + Assigned ADT | -17.2 |
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Change From Baseline in the HAMD-17 Total Score Over the Double-Blind Treatment Period
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. A negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. The data reported is summary of data collected and analyzed during double-blind treatment period at Baseline, Day 3, Day 8, Day 12, and Day 15 using equal weights for the scheduled visits. (NCT04476030)
Timeframe: Baseline through Day 15
Intervention | score on a scale (Least Squares Mean) |
---|
Placebo + Assigned ADT | -10.1 |
SAGE-217 + Assigned ADT | -11.7 |
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