| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder [NCT01109030] | Phase 2/Phase 3 | 50 participants (Actual) | Interventional | 2010-04-30 | Completed |
| Randomized, 2-way Crossover, Bioequivalence Study of Citalopram Hydrobromide 40 mg Tablets and Celexa 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fed Conditions [NCT01149980] | Phase 1 | 24 participants (Actual) | Interventional | 2003-10-31 | Completed |
| Antidepressant Effect of Escitalopram: Delay of Onset. Clinical Randomized Double-blinded Study With Three Parallel Treatment Groups (Escitalopram 20mg vs Escitalopram 30mg vs Escitalopram 20 mg + Pindolol 15 mg/Day [NCT01219686] | Phase 2/Phase 3 | 18 participants (Actual) | Interventional | 2010-10-31 | Terminated(stopped due to Recruitment difficulties) |
| Potential Predictive Biological Markers of Major Depression Response to Citalopram Therapy in Patients With Anorexia Nervosa: a Single-center Study. [NCT05795283] | | 123 participants (Anticipated) | Observational | 2022-08-01 | Recruiting |
| Chinese Longitudinal and Systematic Study of Bioplar Disorder [NCT05480150] | | 10,000 participants (Anticipated) | Interventional | 2021-11-01 | Recruiting |
| Fase III Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode [NCT02532660] | Phase 3 | 111 participants (Actual) | Interventional | 2018-07-02 | Terminated(stopped due to Recruitment difficulties due to monocentric study) |
| [NCT00149825] | Phase 2 | 30 participants (Actual) | Interventional | 2004-06-30 | Completed |
| Escitalopram and Language Intervention for Subacute Aphasia (ELISA) [NCT03843463] | Phase 2 | 88 participants (Anticipated) | Interventional | 2021-07-18 | Recruiting |
| Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fasting State [NCT00865085] | Phase 1 | 28 participants (Actual) | Interventional | 2003-06-30 | Completed |
| The Role of Serotonin in Compulsive Behavior in Humans: Underlying Brain Mechanisms [NCT04336228] | Phase 4 | 48 participants (Anticipated) | Interventional | 2020-04-01 | Recruiting |
| A Phase I, Open-label, Randomized, 3-way Crossover Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC435 and Escitalopram at Steady-state [NCT01090700] | Phase 1 | 20 participants (Actual) | Interventional | 2010-05-31 | Completed |
| A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group, Flexible Dose Titration, Add-On Study of TC-5214 in the Treatment of MDD With Subjects Who Are Partial Responders or Non-Responders to Citalopram Therapy [NCT00692445] | Phase 2 | 574 participants (Actual) | Interventional | 2008-06-30 | Completed |
| Randomized, 2-way Crossover, Bioequivalence Study of Citalopram Hydrobromide 40 mg Tablets and Celexa 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fasting Conditions [NCT01149967] | Phase 1 | 24 participants (Actual) | Interventional | 2003-10-31 | Completed |
| Adherence to Antidepressant Treatment in Subjects With Depression [NCT03388164] | Phase 2 | 23 participants (Actual) | Interventional | 2018-01-01 | Terminated(stopped due to The study was terminated early based on the planned interim analysis that did not meet criteria for continuation.) |
| Continuation Electroconvulsive Therapy Associated With Pharmacotherapy Versus Pharmacotherapy Alone for Relapse Prevention in Major Depression. A Clinical, Controlled, Prospective and Randomized Trial [NCT01305707] | Phase 4 | 104 participants (Actual) | Interventional | 2009-07-31 | Terminated(stopped due to Difficulties in recruiting) |
| A Pilot Study Utilizing Escitalopram to Address Cognitive Dysfunction in Glioma Patients [NCT03728673] | Phase 2 | 20 participants (Anticipated) | Interventional | 2019-03-06 | Recruiting |
| A Randomized Clinical Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depressive Patients [NCT06054321] | | 400 participants (Anticipated) | Interventional | 2022-08-03 | Recruiting |
| Stress and Inflammation in the Pathophysiology of Late Life Depression [NCT02389465] | Phase 4 | 119 participants (Actual) | Interventional | 2014-08-31 | Completed |
| The Role of PKC Activation in the Immune-inflammatory Mechanism of Major Depressive Depression [NCT04156425] | | 180 participants (Anticipated) | Interventional | 2020-07-01 | Not yet recruiting |
| A Randomized Double-blind Parallel Innovator-Controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram Oxalate Tablets in the Treatment of Chinese Patients With Depression [NCT00866593] | Phase 2/Phase 3 | 260 participants (Actual) | Interventional | 2009-03-31 | Completed |
| Pentoxifylline as a New Adjuvant in Adult Patients With Major Depressive Disorder: Randomized, Double Blind, Placebo Controlled Trial. [NCT03554447] | | 80 participants (Actual) | Interventional | 2015-04-20 | Completed |
| Randomized Controlled Trial of Treating Rectal Hypersensitivity - Comparing Escitalopram With Sensory Adaptation Training [NCT00584571] | Phase 2 | 55 participants (Actual) | Interventional | 2007-12-31 | Completed |
| A Randomized, Single Dose, Open Label, Bioequivalence Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects Und [NCT00940238] | Phase 1 | 0 participants | Interventional | | Completed |
| Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning [NCT00935246] | | 202 participants (Anticipated) | Interventional | 2008-12-31 | Active, not recruiting |
| Combination Therapy With Modafinil and Escitalopram for the Treatment of Cocaine Dependence [NCT01601730] | Phase 1 | 68 participants (Actual) | Interventional | 2010-08-31 | Completed |
| Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder [NCT00220701] | Phase 4 | 36 participants (Actual) | Interventional | 2002-06-30 | Completed |
| A Randomized, Single Dose, Open Label, Bioequivalence Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects in [NCT00939835] | Phase 1 | 0 participants | Interventional | | Completed |
| The Objective of This Study Was to Investigate the Bioequivalence of Mylan's Escitalopram Oxalate 20 mg Tablets to Forest's Lexapro® 20 mg Tablets Following a Single, Oral 20 mg (1 x 20 mg) Dose Administered Under Fasting Conditions. [NCT00648570] | Phase 1 | 37 participants (Actual) | Interventional | 2004-08-31 | Completed |
| Randomised Clinical Trial Comparing Early Medication Change (EMC) Strategy With Treatment as Usual (TAU) in Patients With Major Depressive Disorder - the EMC Trial [NCT00974155] | Phase 4 | 889 participants (Actual) | Interventional | 2009-09-30 | Completed |
| Effects of 3 Months of SSRI-Treatment on Metabolism and HPA-axis in Young Men Born With Low Birth Weight - a Randomized, Double Blinded and Placebo-controlled Trial [NCT00971815] | | 60 participants (Actual) | Interventional | 2009-05-31 | Completed |
| A Relative Bioavailability of 10 mg Citalopram Hydrobromide Tablets Under Fasting Conditions [NCT00865943] | Phase 1 | 26 participants (Actual) | Interventional | 2003-07-31 | Completed |
| Combining Antidepressants to Hasten Remission From Depression [NCT00519428] | Phase 4 | 245 participants (Actual) | Interventional | 2007-08-31 | Completed |
| Behavioral Insomnia Therapy For Those With Insomnia and Depression [NCT00620789] | | 477 participants (Anticipated) | Interventional | 2008-03-31 | Recruiting |
| Phase IIa Proof of Concept Study of Pipamperone/Citalopram (PipCit) Versus Citalopram in the Treatment of Major Depressive Disorder (MDD) [NCT00672659] | Phase 2 | 165 participants (Actual) | Interventional | 2008-02-29 | Completed |
| Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study of Escitalopram in Combination With Two Fixed Doses of Gaboxadol Compared to Escitalopram in Major Depressive Disorder [NCT00807248] | Phase 2 | 490 participants (Actual) | Interventional | 2008-11-30 | Completed |
| Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects [NCT04097288] | Phase 1 | 24 participants (Actual) | Interventional | 2019-09-17 | Completed |
| Single-Dose Food In Vivo Bioequivalence Study of Escitalopram Oxalate Tablets (20 mg; Mylan) to Lexapro® Tablets (20 mg; Forest) in Healthy Volunteers [NCT00648661] | Phase 1 | 35 participants (Actual) | Interventional | 2004-09-30 | Completed |
| Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder [NCT00813735] | Phase 4 | 60 participants (Actual) | Interventional | 2006-09-30 | Completed |
| Determination of the Circadian Resetting Effects of Escitalopram and Testing for Correlations Between Circadian Resetting and Antidepressant Effects [NCT01214044] | | 19 participants (Actual) | Interventional | 2008-05-31 | Completed |
| A Single-dose, Open-label, Randomised, Crossover Bioequivalence Study in Healthy Young Men Comparing Two Formulations of Escitalopram [NCT01395433] | Phase 1 | 32 participants (Actual) | Interventional | 2010-01-31 | Completed |
| Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fed State [NCT00864890] | Phase 1 | 32 participants (Actual) | Interventional | 2003-06-30 | Completed |
| A Pilot Study -- An Open-Label, Rater-blinded, Flexible-dose, 8-week Trial of Escitalopram (Lexapro®) In Patients With Major Depression With Atypical Features. [NCT00610506] | Phase 3 | 15 participants (Actual) | Interventional | 2005-10-31 | Completed |
| A Study to Investigate the Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder (MDD) Patients [NCT00926835] | Phase 4 | 692 participants (Actual) | Interventional | 2009-05-31 | Terminated(stopped due to due to patient recruitment difficulties) |
| Sinusitis and Facial Pain Disorders Anti-Depression Trial [NCT00754793] | Phase 4 | 3 participants (Actual) | Interventional | 2009-01-31 | Terminated(stopped due to poor recruitment) |
| Symptom Management Trial in Cancer Survivors [NCT00387348] | Phase 3 | 24 participants (Actual) | Interventional | 2006-03-31 | Terminated(stopped due to DSMB stopped study because placebo arm had more adverse events) |
| Escitalopram and Transcranial Direct Current Stimulation in Major Depressive Disorder: a Double-blind, Placebo-controlled, Randomized, Non-inferiority Trial [NCT01894815] | Phase 3 | 245 participants (Actual) | Interventional | 2013-10-31 | Completed |
| An Open Label, Randomised, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Escitalopram Oxalate Tablet Containing Escitalopram (20mg) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Lexapro® Tablet (20mg) [Reference Fo [NCT01996462] | Phase 1 | 0 participants | Interventional | | Completed |
| An Open Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Escitalopram Oxalate Tablet 20mg [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Lexapro® (Escitalopram Oxalate Tablet 20mg) [Reference Formula [NCT01996475] | Phase 1 | 0 participants | Interventional | | Completed |
| Brain Mechanisms and Targeting Insomnia in Major Depression [NCT00628914] | Phase 4 | 60 participants (Anticipated) | Interventional | 2008-05-31 | Active, not recruiting |
| Genetic-pharmacological Neuroimaging of the Serotonergic System in Violent Video Games [NCT01644071] | | 47 participants (Actual) | Interventional | 2012-02-29 | Completed |
| Unraveling the Nature of Impaired Pain Inhibition in Patients With Chronic Whiplash-associated Disorders: a Randomized Controlled Clinical Trial for the Treatment of Central Sensitization [NCT01601912] | | 59 participants (Actual) | Observational | 2013-02-28 | Completed |
| Relapse Prevention in Patients With a Major Depressive Episode Treated With Electroconvulsive Treatment Using a Fixed Dose Range of Escitalopram Compared to a Fixed Dose of Nortriptyline (DUAG-7) A Randomised Controlled 6 Month Double-blind Study [NCT00660062] | Phase 4 | 47 participants (Actual) | Interventional | 2009-08-31 | Terminated(stopped due to Slow inclusion) |
| Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture [NCT02579343] | | 13 participants (Actual) | Interventional | 2015-08-31 | Completed |
| Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs in Healthy Korean Adults After a Single Oral Administration of Escitalopram, Quetiapine, and Moxifloxacin [NCT01871701] | Phase 1 | 40 participants (Actual) | Interventional | 2012-11-30 | Completed |
| A Comparative Study on Efficacy and Safety of add-on Sulforaphane or rTMS to Escitalopram for Major Depressive Disorder With Poor Response to Initial Treatment [NCT05145270] | Phase 4 | 180 participants (Anticipated) | Interventional | 2019-11-30 | Recruiting |
| Algorithm Guided Treatment Strategies for Major Depressive Disorder [NCT01764867] | Phase 4 | 1,080 participants (Anticipated) | Interventional | 2012-06-30 | Recruiting |
| Depression: The Search for Treatment-Relevant Phenotypes [NCT00073697] | Phase 4 | 290 participants (Actual) | Interventional | 2003-05-31 | Completed |
| Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior [NCT00086645] | Phase 2 | 149 participants (Actual) | Interventional | 2004-04-30 | Completed |
| The Effects of Increased Central Serotonergic Activity on Psychophysiological Parameters of Human Information Processing [NCT00206934] | | 40 participants (Actual) | Interventional | 2005-03-31 | Completed |
| The Effect of Antidepressants and Gabapentin on Tamoxifen Pharmacokinetics: A Prospective Study [NCT00667121] | | 85 participants (Anticipated) | Observational | 2011-03-16 | Active, not recruiting |
| Molecular Markers of Neuroplasticity During High-Intensity Exercise in Subjects With Incomplete Spinal Cord Injury [NCT01538693] | | 30 participants (Anticipated) | Interventional | 2011-12-31 | Completed |
| Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder [NCT01541475] | Phase 4 | 60 participants (Actual) | Interventional | 2009-03-31 | Completed |
| A Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple Sclerosis [NCT00151294] | Phase 4 | 20 participants | Interventional | 2004-11-30 | Terminated |
| A Double-Blind, Placebo-Controlled Study of Acamprosate Added to Escitalopram and Behavioral Treatment in Major Depressive Disorder (MDD) With Comorbid Alcohol Abuse/Dependence [NCT00452543] | Phase 4 | 23 participants (Actual) | Interventional | 2007-03-31 | Completed |
| Combining Medications to Enhance Depression Outcomes [NCT00590863] | Phase 4 | 665 participants (Actual) | Interventional | 2008-03-31 | Completed |
| A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder [NCT00668525] | Phase 3 | 877 participants (Actual) | Interventional | 2008-04-30 | Completed |
| Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication. [NCT00296712] | Phase 4 | 55 participants (Actual) | Interventional | 2005-02-28 | Completed |
| Clinical Trial of Serotonin Medication Combination in Cocaine Dependence [NCT01535573] | Phase 2 | 108 participants (Actual) | Interventional | 2010-12-31 | Completed |
| Ramelteon for Sleep Initiation Insomnia in Panic Disorder Who Are Also on Escitalopram for Anxiety: A Double Blind, Randomized Clinical Trial [NCT00746239] | | 11 participants (Actual) | Interventional | 2008-08-31 | Terminated(stopped due to Funding for continuation was not received.) |
| A Double-blind, Placebo- and Active-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder [NCT01473381] | Phase 4 | 1,162 participants (Actual) | Interventional | 2011-12-31 | Completed |
| Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparations in Tablets Containing Escitalopram 10 mg (Product From GlaxoSmithKline México, S.A. de C.V. vs. Lexapro® 10mg, Lundbeck México, S.A. [NCT01745601] | Phase 1 | 26 participants (Actual) | Interventional | 2010-05-04 | Completed |
| [NCT02423694] | | 252 participants (Anticipated) | Interventional | 2013-09-30 | Recruiting |
| Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes [NCT00363909] | Phase 3 | 254 participants (Actual) | Interventional | 2006-11-30 | Completed |
| An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia [NCT01716221] | Phase 4 | 1 participants (Actual) | Interventional | 2012-10-31 | Completed |
| Antidepressant Treatment at an Inner City Asthma Clinic [NCT01324700] | Phase 4 | 139 participants (Actual) | Interventional | 2010-07-31 | Completed |
| Pipamperone/Citalopram (PNB01) Versus Citalopram (CIT) and Versus Pipamperone (PIP) in the Treatment of Moderate to Severe Major Depressive Disorder (MDD): a Randomized, Double-blind Phase III Study of 10 Weeks [NCT01312922] | Phase 3 | 555 participants (Actual) | Interventional | 2011-09-30 | Completed |
| Personalizing Treatment of Depression Complicated by Panic Features-Pilot Study [NCT00930293] | | 50 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Escitalopram Effects on CSF Amyloid Beta Total Concentrations [NCT02161458] | Phase 4 | 98 participants (Actual) | Interventional | 2014-06-30 | Completed |
| Sertraline Versus Escitalopram in South Asian Participants With Moderate to Severe Major Depressive Disorder: A Double-blind, Parallel, Randomized Controlled Trial [NCT05950061] | Phase 3 | 744 participants (Actual) | Interventional | 2022-06-01 | Completed |
| A Randomised Placebo-Controlled Trial of Escitalopram and Nortriptyline With Standard Psychological Care for Depression in Parkinson's Disease [NCT03652870] | Phase 3 | 52 participants (Actual) | Interventional | 2021-03-05 | Completed |
| A Double-blinded 6-week Prospective Study to Evaluate the Remission Rate According to Dose of Escitalopram (Lexapro®) in Patients With Major Depressive Disorder: a Preliminary Study [NCT01594866] | Phase 4 | 60 participants (Anticipated) | Interventional | 2012-05-31 | Completed |
| Testing an Imaging Biomarker for Treatment Stratification in Major Depression [NCT02137369] | Phase 4 | 77 participants (Actual) | Interventional | 2014-09-30 | Completed |
| Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals [NCT00218036] | Phase 2 | 54 participants (Actual) | Interventional | 2006-07-31 | Terminated(stopped due to PI left institution, end of funding, clinic relocation, recruitment issues) |
| Effect of Serotonin and Levodopa Functional Recovery in Patients With Cerebral Infarction [NCT02386475] | Phase 4 | 39 participants (Actual) | Interventional | 2015-01-31 | Completed |
| Efficacy of Hydroxyzine Versus Treatment as Usual for Panic Disorder: An Eight-Week, Open Label, Pilot, Randomized Controlled Trial. [NCT05737511] | Phase 4 | 80 participants (Anticipated) | Interventional | 2023-12-30 | Not yet recruiting |
| Brain Imaging and Treatment Studies of the Night Eating Syndrome [NCT01401595] | Phase 3 | 87 participants (Actual) | Interventional | 2009-12-31 | Completed |
| Escitalopram in the Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial [NCT00621946] | Phase 4 | 26 participants (Actual) | Interventional | 2008-03-31 | Completed |
| Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon [NCT00642694] | Phase 3 | 29 participants (Actual) | Interventional | 2007-05-31 | Terminated(stopped due to Enrollment discontinued based on mutually agreed upon decision by PI and funding sponsor) |
| The Effect of Patient and Investigator Expectation on the Efficacy of Escitalopram in the Treatment of Patients With Major Depressive Disorder. [NCT02480400] | | 52 participants (Actual) | Interventional | 2010-06-30 | Completed |
| Effectiveness and Safety of Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS) for Patients With Mild-to-moderate Depression. [NCT03909217] | Phase 2/Phase 3 | 470 participants (Anticipated) | Interventional | 2019-07-29 | Recruiting |
| Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): Study Design of a Randomized Controlled Trial [NCT05901571] | | 216 participants (Anticipated) | Interventional | 2023-09-30 | Not yet recruiting |
| Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial [NCT05271084] | Phase 1/Phase 2 | 100 participants (Actual) | Interventional | 2021-11-10 | Completed |
| Study on the Optimal Diagnosis and Treatment Strategy of Major Depressive Disorder Based on Anhedonia [NCT05389046] | | 252 participants (Anticipated) | Interventional | 2022-10-31 | Not yet recruiting |
| Depression Treatment and Aβ Dynamics: A Study of Alzheimer's Disease Risk (ABD Study) [NCT05004987] | Phase 4 | 90 participants (Anticipated) | Interventional | 2022-02-04 | Recruiting |
| A Multi-centre, Randomised, Double-blind, Parallel Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release (Bupropion XL 300mg Once Daily), Escitalopram Oxalate (Escitalopram, 10mg-20mg Once Dai [NCT02191397] | Phase 3 | 534 participants (Actual) | Interventional | 2015-02-10 | Completed |
| Brain Function and Structure in Cocaine Dependence [NCT02080832] | Phase 2 | 54 participants (Actual) | Interventional | 2010-02-28 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
| Trial | Outcome |
|---|
| NCT00149825 (2) [back to overview] | Remission of Depression (%) |
| NCT00149825 (2) [back to overview] | Remission of Insomnia |
| NCT00220701 (6) [back to overview] | Hamilton-Depression Rating Scale (HDRS-24 Items) |
| NCT00220701 (6) [back to overview] | Hamilton-Depression Rating Scale (HDRS-24 Items) |
| NCT00220701 (6) [back to overview] | Beck Depression Inventory (BDI) |
| NCT00220701 (6) [back to overview] | Beck Depression Inventory (BDI) |
| NCT00220701 (6) [back to overview] | Clinical Global Impressions - Severity (CGI-S) |
| NCT00220701 (6) [back to overview] | Clinical Global Impressions - Severity (CGI-S) |
| NCT00387348 (3) [back to overview] | Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder |
| NCT00387348 (3) [back to overview] | Change in Hamilton Depression Rating Scale (HAM-D) Scores |
| NCT00387348 (3) [back to overview] | Side Effect Burden |
| NCT00452543 (4) [back to overview] | Total Drinking Days on the Alcohol Timeline Followback (TLFB) |
| NCT00452543 (4) [back to overview] | Total Drinks Consumed Per Drinking Day on the TLFB |
| NCT00452543 (4) [back to overview] | Total Drinks Consumed Per Week on the TLFB |
| NCT00452543 (4) [back to overview] | Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17) |
| NCT00519428 (5) [back to overview] | Functioning, as Measured by the Social Adjustment Scale (SAS) Summary Score |
| NCT00519428 (5) [back to overview] | Quality of Life, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form (SF) |
| NCT00519428 (5) [back to overview] | Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7 |
| NCT00519428 (5) [back to overview] | Severity of Depressive Symptoms as Measured by Hamilton Rating Scale for Depression (HAM-D 17) |
| NCT00519428 (5) [back to overview] | Remission: Persistent Hamilton Rating Scale for Depression, 17 Items (HAM-D 17) <= 7, With no HAM-D 17 >7 Through Week 12 |
| NCT00590863 (2) [back to overview] | Quality of Life Inventory |
| NCT00590863 (2) [back to overview] | Quick Inventory of Depressive Symptoms |
| NCT00621946 (6) [back to overview] | ACQ (Asthma Control Questionnaire) |
| NCT00621946 (6) [back to overview] | IDS-SR (Inventory of Depressive Symptomatology - Self-Report) |
| NCT00621946 (6) [back to overview] | HAM-D (Hamilton Rating Scale for Depression) |
| NCT00621946 (6) [back to overview] | HAM-D (Hamilton Rating Scale for Depression) |
| NCT00621946 (6) [back to overview] | ACQ (Asthma Control Questionnaire) |
| NCT00621946 (6) [back to overview] | IDS-SR (Inventory of Depressive Symptomatology - Self-Report) |
| NCT00642694 (9) [back to overview] | Work and Social Adjustment Scale (WSAS) |
| NCT00642694 (9) [back to overview] | Social Adjustment Scale - Self-Report (SAS-SR) |
| NCT00642694 (9) [back to overview] | Sleep Latency |
| NCT00642694 (9) [back to overview] | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) |
| NCT00642694 (9) [back to overview] | Percentage of Remitters on IDS-C30 at Week 12 |
| NCT00642694 (9) [back to overview] | Patient Perception of Benefits of Care (PPBC) |
| NCT00642694 (9) [back to overview] | Hamilton Rating Scale for Depression 17-item |
| NCT00642694 (9) [back to overview] | Short-Form Health Survey - Version 2 (SF-36) |
| NCT00642694 (9) [back to overview] | Work Productivity and Activity Impairment Questionnaire (WPAI) |
| NCT00668525 (2) [back to overview] | Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks. |
| NCT00668525 (2) [back to overview] | Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8 |
| NCT00807248 (9) [back to overview] | MADRS |
| NCT00807248 (9) [back to overview] | Clinical Global Impression - Global Improvement (CGI-I) |
| NCT00807248 (9) [back to overview] | Clinical Global Impression - Severity of Illness (CGI-S) |
| NCT00807248 (9) [back to overview] | Hospital Anxiety and Depression Scale (HADS) |
| NCT00807248 (9) [back to overview] | Insomnia Severity Index (ISI) |
| NCT00807248 (9) [back to overview] | Montgomery and Åsberg Depression Rating Scale (MADRS) |
| NCT00807248 (9) [back to overview] | SDS: Social Subscale |
| NCT00807248 (9) [back to overview] | SDS: Work Subscale |
| NCT00807248 (9) [back to overview] | Sheehan Disability Scale (SDS): Family Subscale |
| NCT00930293 (2) [back to overview] | Number of Participants Meeting Depression Remission Criteria |
| NCT00930293 (2) [back to overview] | Weeks to Depression Remission |
| NCT01214044 (4) [back to overview] | Change in Beck Depression Inventory II (BDI-II) Scores |
| NCT01214044 (4) [back to overview] | Change in Hamilton Depression Rating Scale (HAM-D) Scores |
| NCT01214044 (4) [back to overview] | Change in Phase Angle Difference (PAD) |
| NCT01214044 (4) [back to overview] | Change in Dim Light Melatonin Onset |
| NCT01312922 (1) [back to overview] | Early and Sustained (Antidepressant) Response (ESR) Rate |
| NCT01324700 (2) [back to overview] | Asthma Control Questionnaire (ACQ) |
| NCT01324700 (2) [back to overview] | Hamilton Rating Scale for Depression (HRSD) |
| NCT01401595 (3) [back to overview] | Change in Symptoms of NES |
| NCT01401595 (3) [back to overview] | Night Eating Symptoms |
| NCT01401595 (3) [back to overview] | Nocturnal Ingestions |
| NCT01473381 (3) [back to overview] | Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10 |
| NCT01473381 (3) [back to overview] | Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response |
| NCT01473381 (3) [back to overview] | Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score |
| NCT01535573 (4) [back to overview] | Retention as Assessed by Number of Participants Remaining in Treatment |
| NCT01535573 (4) [back to overview] | Proportion of Cocaine-positive Urines Per Week |
| NCT01535573 (4) [back to overview] | Number of Participants With Cocaine-negative Urines Collected During Treatment Period |
| NCT01535573 (4) [back to overview] | Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test |
| NCT01716221 (4) [back to overview] | Friedreich Ataxia Rating Scale (FARS) |
| NCT01716221 (4) [back to overview] | Comparison of FARS and ICARS |
| NCT01716221 (4) [back to overview] | International Cooperative Ataxia Rating Scale (ICARS) |
| NCT01716221 (4) [back to overview] | Hamilton Depression Rating Scale |
| NCT02080832 (4) [back to overview] | fMRI Brain Activation in Right Inferior Frontal Gyrus |
| NCT02080832 (4) [back to overview] | Cocaine Use/Treatment Effectiveness Score (TES) |
| NCT02080832 (4) [back to overview] | fMRI Brain Activation in Right Precentral Gyrus |
| NCT02080832 (4) [back to overview] | fMRI Brain Activation in Right Orlandic Operculum |
| NCT02137369 (2) [back to overview] | Number of Remission From Major Depressive Episode Events |
| NCT02137369 (2) [back to overview] | Number of Response to Treatment Events |
| NCT02161458 (1) [back to overview] | Amyloid Beta Levels in CSF |
| NCT02191397 (27) [back to overview] | Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia Suicide Severity Rating Scale (C-SSRS) |
| NCT02191397 (27) [back to overview] | Number of Participants With Urinalysis Data Outside the Normal Range |
| NCT02191397 (27) [back to overview] | Number of Participants With Vital Sign Parameters Outside the Clinical Concern Range |
| NCT02191397 (27) [back to overview] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points |
| NCT02191397 (27) [back to overview] | Change From Baseline in Changes in Sexual Function Questionnaire (CSFQ) |
| NCT02191397 (27) [back to overview] | Mean Change in Hamilton Depression Rating Scale - 17 (HAMD-17) Total Score From Baseline to End of Acute Treatment Phase (Week 8) |
| NCT02191397 (27) [back to overview] | Response Rate Based on HAMD-17 Total Score |
| NCT02191397 (27) [back to overview] | Sustained Remission Rate Based on HAMD-17 Total Score |
| NCT02191397 (27) [back to overview] | Sustained Response Rate Based on HAMD-17 Total Score |
| NCT02191397 (27) [back to overview] | "Percentage of Participants With a Clinical Global Impression Global Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved) at Weeks 1, 2, 4, 6 and 8" |
| NCT02191397 (27) [back to overview] | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points |
| NCT02191397 (27) [back to overview] | Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points |
| NCT02191397 (27) [back to overview] | Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Weeks 1, 2, 4, 6 and 8 |
| NCT02191397 (27) [back to overview] | Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score (Sum of Scores of Items 10, 11, 12, 13, 15 and 17) at Weeks 1, 2, 4, 6 and 8 |
| NCT02191397 (27) [back to overview] | Change From Baseline in HAMD-17 Depressed Mood Subscale Score (Score of Item 1) at Weeks 1, 2, 4, 6 and 8 |
| NCT02191397 (27) [back to overview] | Change From Baseline in HAMD-17 Retardation Subscale Score (Sum of Scores of Items 1, 7, 8 and 14) at Weeks 1, 2, 4, 6 and 8 |
| NCT02191397 (27) [back to overview] | Change From Baseline in HAMD-17 Sleep Disorder Subscale Score (Sum of Scores of Items 4, 5 and 6) at Weeks 1, 2, 4, 6 and 8 |
| NCT02191397 (27) [back to overview] | Change From Baseline in Hematocrit at the Indicated Time Points |
| NCT02191397 (27) [back to overview] | Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points |
| NCT02191397 (27) [back to overview] | Remission Rate Based on HAMD-17 Total Score |
| NCT02191397 (27) [back to overview] | Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points |
| NCT02191397 (27) [back to overview] | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Weeks 1, 2, 4, 6 and 8 |
| NCT02191397 (27) [back to overview] | Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points |
| NCT02191397 (27) [back to overview] | Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points |
| NCT02191397 (27) [back to overview] | Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points |
| NCT02191397 (27) [back to overview] | Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious AE (SAE) |
| NCT02191397 (27) [back to overview] | Number of Participants With Electrocardiogram (ECG) Data Outside the Clinical Concern Range |
| NCT02389465 (3) [back to overview] | IL-6 Levels |
| NCT02389465 (3) [back to overview] | IL10 Levels |
| NCT02389465 (3) [back to overview] | Montgomery Asberg Depression Rating Scale (MADRS) |
| NCT02579343 (2) [back to overview] | Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks |
| NCT02579343 (2) [back to overview] | Change of Mean Score of the Behavioral Health Measure-20 Between Baseline and End of Study |
| NCT03388164 (2) [back to overview] | Adherence Consistency |
| NCT03388164 (2) [back to overview] | Rate of Adherence |
Remission of Depression (%)
"Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID.~The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms.~The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains)." (NCT00149825)
Timeframe: After 12 weeks or at the last available time point
| Intervention | percent of participants (Number) |
|---|
| MED+CBTI | 61.5 |
| MED+CTRL | 33.3 |
Remission of Insomnia
Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score < 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score < 8 indicates absence of insomnia. (NCT00149825)
Timeframe: After 12 weeks or at the last available time point
| Intervention | percent (Number) |
|---|
| MED+CBTI | 50.0 |
| MED+CTRL | 7.7 |
Hamilton-Depression Rating Scale (HDRS-24 Items)
Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) (NCT00220701)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Escitalopram | 22.82 |
| Placebo | 24.41 |
Hamilton-Depression Rating Scale (HDRS-24 Items)
Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) (NCT00220701)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| Escitalopram | 10.88 |
| Placebo | 16.41 |
Beck Depression Inventory (BDI)
21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression. (NCT00220701)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Escitalopram | 15.00 |
| Placebo | 16.25 |
Beck Depression Inventory (BDI)
21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression. (NCT00220701)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| Escitalopram | 6.76 |
| Placebo | 10.00 |
Clinical Global Impressions - Severity (CGI-S)
Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology) (NCT00220701)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Escitalopram | 4.06 |
| Placebo | 4.06 |
Clinical Global Impressions - Severity (CGI-S)
Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology) (NCT00220701)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| Escitalopram | 2.35 |
| Placebo | 3.41 |
Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder
Response rate was defined as a 50% reduction in the Hamilton Depression Rating Scale (HAM-D) scores over 4 weeks. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range. (NCT00387348)
Timeframe: 4 weeks
| Intervention | number of participants with response (Number) |
|---|
| Placebo-Placebo | 3 |
| Placebo-Escitalopram | 1 |
| Escitalopram-Placebo | 6 |
Change in Hamilton Depression Rating Scale (HAM-D) Scores
The change in HAM-D scores was calculated by subtracting the score at 4 weeks from the score at baseline. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range. (NCT00387348)
Timeframe: 4 weeks
| Intervention | Change in HAM-D scores (Mean) |
|---|
| Placebo-Placebo | 6.23 |
| Placebo-Escitalopram | 10.60 |
| Escitalopram-Placebo | 6.45 |
Side Effect Burden
Side efect burden was defined as the total score of the UKU Side Effects Rating Scale. This scale contains 48 items corresponding to side effects which are rated from 0-3, with 0 meaning not present and 1-3 rating the severity of the side effect. Higher scores represented greater side effect burden. The scale range is 0 to 144. (NCT00387348)
Timeframe: 4 weeks
| Intervention | units on a scale (Mean) |
|---|
| Placebo-Placebo | 3.00 |
| Placebo-Escitalopram | 2.50 |
| Escitalopram-Placebo | 3.44 |
Total Drinking Days on the Alcohol Timeline Followback (TLFB)
The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period ranging from 7 days to 24 months prior to the interview, and thus the measure provides quantitative estimates of alcohol use. One standard drink on the TLFB was defined as: 12 oz beer (5% alcohol by volume), 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). We measure the change from Baseline to Week 12 or week of early termination visit. (NCT00452543)
Timeframe: From Baseline visit to Week 12 (or early discontinuation visit)
| Intervention | Drinking days (Mean) |
|---|
| Escitalopram Plus Acamprosate | 61 |
| Escitalopram Plus Placebo | 61 |
Total Drinks Consumed Per Drinking Day on the TLFB
Total Drinks Consumed per Drinking Day on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit. (NCT00452543)
Timeframe: From Baseline visit to Week 12 (or early discontinuation visit)
| Intervention | Drinks consumed per drinking day (Mean) |
|---|
| Escitalopram Plus Acamprosate | 4 |
| Escitalopram Plus Placebo | 4 |
Total Drinks Consumed Per Week on the TLFB
Total Drinks Consumed per Week on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit. (NCT00452543)
Timeframe: From Baseline visit to Week 12 (or early discontinuation visit)
| Intervention | Drinks consumed per week (Mean) |
|---|
| Escitalopram Plus Acamprosate | 15 |
| Escitalopram Plus Placebo | 15 |
Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17)
Scores on the HAM-D-17 typically fall into the following ranges: a) Not depressed: 0-7; b) Mildly depressed: 7-15; c) Moderately depressed: 15-25; d) Severely depressed: over 25. A decrease of 50% or more in the Hamilton-D score is considered to be a positive response to treatment, while a score of 7 or less is considered typical of remission. We measure the change in total score from Baseline to Week 12 or week of early termination visit. (NCT00452543)
Timeframe: From baseline visit to Week 12 (or early discontinuation visit)
| Intervention | Scores on a scale (Mean) |
|---|
| Escitalopram Plus Acamprosate | -5.6 |
| Escitalopram Plus Placebo | -7.8 |
Functioning, as Measured by the Social Adjustment Scale (SAS) Summary Score
Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning (NCT00519428)
Timeframe: 12 weeks
| Intervention | units on the SAS scale (Mean) |
|---|
| Escitalopram + Bupropion | 2.65 |
| Escitalopram | 2.63 |
| Bupropion | 2.74 |
Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7
Life Table Survival Analysis run twice, once comparing Dual Therapy (i.e., Bupropion + Escitalopram) to Bupropion alone (i.e., Bupropion + Placebo) and once comparing Dual Therapy to Escitalopram alone (i.e., Escitalopram + Placebo). Because both analyses must significantly favor Dual Therapy, each individual analysis must reach a critical alpha = .0916 in order to reach an over-all alpha = .05. (NCT00519428)
Timeframe: 12 weeks
| Intervention | weeks (Mean) |
|---|
| Escitalopram + Bupropion | 8 |
| Escitalopram | 9 |
| Bupropion | 10 |
Severity of Depressive Symptoms as Measured by Hamilton Rating Scale for Depression (HAM-D 17)
"Last summary score rating on the 17-item Hamilton Rating Scale for Depression Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Range 0-58.~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥ 23 = Very Severe Depression" (NCT00519428)
Timeframe: 12 weeks
| Intervention | units on Hamilton Rating Scale for Depre (Mean) |
|---|
| Escitalopram + Bupropion | 10 |
| Escitalopram | 9 |
| Bupropion | 12 |
Remission: Persistent Hamilton Rating Scale for Depression, 17 Items (HAM-D 17) <= 7, With no HAM-D 17 >7 Through Week 12
Chi square comparison of rates of persistent remission (i.e., no subsequent Hamilton Rating Scale for Depression, 17 items [HAMD-D 17] > 7 once HAMD-D 17 <= 7); Dual rate vs. Escitalopram only rate and Dual rate vs. Bupropion only rate. (NCT00519428)
Timeframe: 12 weeks
| Intervention | percentage of participants (Number) |
|---|
| Escitalopram + Bupropion | 52 |
| Escitalopram | 46 |
| Bupropion | 34 |
Quality of Life Inventory
The Quality of Life Inventory (QOLI) is a 32-item comprehensive self-report of satisfaction in 16 areas of life, such as love, work, and health. Each area is rated in terms of satisfaction and the relationship of that area to overall quality of life. It yields an overall raw score and satisfaction ratings for the 16 individual areas of life. The QOLI raw score is an average of weighted satisfaction ratings computed only over areas of life judged to be Important or Extremely Important to the respondent. Higher scores indicate higher reported quality of life. (NCT00590863)
Timeframe: Measured at Month 7
| Intervention | units on a scale (Mean) |
|---|
| Escitalopram + Bupropion SR | 0.6 |
| Venlafaxine XR + Mirtazapine | 0.4 |
| Escitalopram + Placebo | 0.4 |
Quick Inventory of Depressive Symptoms
Percentage of patients that achieve remission, as defined as QIDS total score below 6 for last 2 study visits. QIDS depression scores range from 0 (normal) to 27 (very severe). (NCT00590863)
Timeframe: Measured at Month 7
| Intervention | percentage of participants (Number) |
|---|
| Escitalopram + Bupropion SR | 46.6 |
| Venlafaxine XR + Mirtazapine | 41.8 |
| Escitalopram + Placebo | 46.0 |
ACQ (Asthma Control Questionnaire)
The ACQ is a questionnaire used to assess symptoms pertinent to asthma management. Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items). (NCT00621946)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Escitalopram | 1.9 |
| Placebo | 2.9 |
IDS-SR (Inventory of Depressive Symptomatology - Self-Report)
The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome). (NCT00621946)
Timeframe: Up to 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| Escitalopram | 26.3 |
| Matching Placebo | 24.6 |
HAM-D (Hamilton Rating Scale for Depression)
The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome). (NCT00621946)
Timeframe: Up to 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| Escitalopram | 16.7 |
| Matching Placebo | 17.7 |
HAM-D (Hamilton Rating Scale for Depression)
The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome). (NCT00621946)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Escitalopram | 24.8 |
| Placebo | 28.3 |
ACQ (Asthma Control Questionnaire)
The ACQ is a questionnaire used to assess symptoms pertinent to asthma management.Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items). (NCT00621946)
Timeframe: Up to 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| Escitalopram | 1.9 |
| Matching Placebo | 2.4 |
IDS-SR (Inventory of Depressive Symptomatology - Self-Report)
The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome). (NCT00621946)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Escitalopram | 35.2 |
| Placebo | 42.9 |
Work and Social Adjustment Scale (WSAS)
The Work and Social Adjustment Scale (WSAS) is 5-item self-report measure designed to identify functional impairment that is attributed to an identified problem or condition. and has been used in studies of depression and anxiety. Scores range between 0-40, with higher scores indicating worse functioning. (NCT00642694)
Timeframe: 12 Weeks
| Intervention | score on a scale (Mean) |
|---|
| Escitalopram + Ramelteon | 15.56 |
| Escitalopram + Placebo | 13.91 |
Social Adjustment Scale - Self-Report (SAS-SR)
The Social Adjustment Scale - Self-Report (SAS-SR) is a 54-item self-report measure of instrumental and expressive role performance. Each item is rated on a 5-point scale, and a mean item score (ranging from 1-5) is obtained, with higher scores indicating greater impairment. (NCT00642694)
Timeframe: 12 Weeks
| Intervention | mean score on a scale (Mean) |
|---|
| Escitalopram + Ramelteon | 2.09 |
| Escitalopram + Placebo | 2.03 |
Sleep Latency
Number of minutes until fell asleep (NCT00642694)
Timeframe: 12 weeks
| Intervention | minutes (Mean) |
|---|
| Escitalopram + Ramelteon | 30.4 |
| Escitalopram + Placebo | 15.8 |
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) measures satisfaction and enjoyment in various domains of functioning: physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and ranges from 0 to 100. Higher scores indicate greater enjoyment and satisfaction. (NCT00642694)
Timeframe: 12 Weeks
| Intervention | score on a scale (Mean) |
|---|
| Escitalopram + Ramelteon | 69.84 |
| Escitalopram + Placebo | 70.24 |
Percentage of Remitters on IDS-C30 at Week 12
Remission as defined by a score of <12 on the Inventory of Depressive Symptomatology, Clinician-Rated version (IDS-C30) at Week 12; minimum possible score = 0, maximum possible score = 84; higher scores indicate worse symptom severity (NCT00642694)
Timeframe: 12 Weeks
| Intervention | percentage of participants (Number) |
|---|
| Escitalopram + Ramelteon | 20 |
| Escitalopram + Placebo | 36 |
Patient Perception of Benefits of Care (PPBC)
The Patient Perception of Benefits of Care (PPBC) assesses how much patients believe their quality of life will improve in response to medical care or treatment. Scores range between 10-50, with lower scores indicating greater belief that treatment will improve quality of life. (NCT00642694)
Timeframe: 12 Weeks
| Intervention | score on a scale (Mean) |
|---|
| Escitalopram + Ramelteon | 20.33 |
| Escitalopram + Placebo | 20.08 |
Hamilton Rating Scale for Depression 17-item
The Hamilton Rating Scale for Depression is a clinician-administered rating scale that assesses severity of depressive symptoms and is one of the most widely used and validated symptom severity measures for depression. Each of the 17 items is rated by the clinician on either a 3- or a 5 point scale. Total scores range from 0-52, with higher scores indicating greater depressive symptoms. (NCT00642694)
Timeframe: 12 Weeks
| Intervention | score on a scale (Mean) |
|---|
| Escitalopram + Ramelteon | 8.33 |
| Escitalopram + Placebo | 10.08 |
Work Productivity and Activity Impairment Questionnaire (WPAI)
The Work Productivity and Activity Impairment Questionnaire (WPAI) was used to report impairment while working or performing usual daily activities as a result of health problems. The activity impairment item (#6 of WPAI) is rated on a scale of 0-10, with higher scores indicating greater impairment. Scores are multiplied by 10 to obtain percent impairment. (NCT00642694)
Timeframe: 12 Weeks
| Intervention | percentage of time activity was impaired (Mean) |
|---|
| Escitalopram + Ramelteon | 40.00 |
| Escitalopram + Placebo | 32.50 |
Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.
The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms). (NCT00668525)
Timeframe: Change from baseline in MADRS total score at week 8
| Intervention | Units on a scale (Mean) |
|---|
| Escitalopram Low Dose | -12.8 |
| Escitalopram High Dose | -13.4 |
| Placebo | -10.1 |
Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8
The HAMD is a clinician-rated 24-item scale was used to rate the patient's depressive state. It was also used to identify obsessive-compulsive, genital, and somatic symptoms, as well as diurnal variation in the presence of symptoms. Each item was scored on a 3, 4 or 5-point Likert scale. A score of 0 indicated the absence of symptoms, and a score of 2, 3 or 4 indicated symptoms of maximum severity. The total score range is 0 to 74 (higher score indicates a greater depressive state). (NCT00668525)
Timeframe: Change from baseline in HAM-D at week 8
| Intervention | Units on a scale (Mean) |
|---|
| Escitalopram Low Dose | -11.5 |
| Escitalopram High Dose | -11.6 |
| Placebo | -8.5 |
MADRS
The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60. (NCT00807248)
Timeframe: From baseline to Week 8
| Intervention | Scores on a scale (Least Squares Mean) |
|---|
| Placebo (Orally, Once Daily) | -13.4 |
| Escitalopram 20 mg and Placebo (Orally, Once Daily) | -19.0 |
| Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) | -18.5 |
| Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) | -19.4 |
Clinical Global Impression - Global Improvement (CGI-I)
The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00807248)
Timeframe: at Week 8
| Intervention | Scores on a scale (Mean) |
|---|
| Placebo (Orally, Once Daily) | 2.97 |
| Escitalopram 20 mg and Placebo (Orally, Once Daily) | 2.21 |
| Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) | 2.35 |
| Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) | 2.26 |
Clinical Global Impression - Severity of Illness (CGI-S)
The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). (NCT00807248)
Timeframe: Mean change from baseline to Week 8
| Intervention | Scores on a scale (Mean) |
|---|
| Placebo (Orally, Once Daily) | -1.04 |
| Escitalopram 20 mg and Placebo (Orally, Once Daily) | -1.65 |
| Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) | -1.58 |
| Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) | -1.76 |
Hospital Anxiety and Depression Scale (HADS)
The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21, and are analysed separately. The total HADS score ranges from 0 to 42. (NCT00807248)
Timeframe: Mean change from baseline to Week 8
| Intervention | Scores on a scale (Mean) |
|---|
| Placebo (Orally, Once Daily) | -9.7 |
| Escitalopram 20 mg and Placebo (Orally, Once Daily) | -14.7 |
| Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) | -14.1 |
| Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) | -15.0 |
Insomnia Severity Index (ISI)
The ISI is both a brief screening measure of insomnia and an outcomes measure for use in treatment research. It is a brief self-report instrument measuring the patient's perception of his or her insomnia, and it comprises 7 items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28. 0 = no symptoms and 28 = severe symptoms. (NCT00807248)
Timeframe: Mean change from baseline to Week 8
| Intervention | Scores on a scale (Mean) |
|---|
| Placebo (Orally, Once Daily) | -6.9 |
| Escitalopram 20 mg and Placebo (Orally, Once Daily) | -10.0 |
| Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) | -9.6 |
| Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) | -10.6 |
Montgomery and Åsberg Depression Rating Scale (MADRS)
The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60. (NCT00807248)
Timeframe: Baseline to 8 weeks
| Intervention | Scores on a scale (Mean) |
|---|
| Placebo (Orally, Once Daily) | -13.4 |
| Escitalopram 20 mg and Placebo (Orally, Once Daily) | -19.0 |
| Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) | -18.5 |
| Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) | -19.4 |
SDS: Social Subscale
The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. (NCT00807248)
Timeframe: Mean change from baseline to Week 8
| Intervention | Scores on a scale (Mean) |
|---|
| Placebo (Orally, Once Daily) | -2.7 |
| Escitalopram 20 mg and Placebo (Orally, Once Daily) | -3.9 |
| Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) | -3.8 |
| Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) | -4.1 |
SDS: Work Subscale
The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. (NCT00807248)
Timeframe: Mean change from baseline to Week 8
| Intervention | Scores on a scale (Mean) |
|---|
| Placebo (Orally, Once Daily) | -2.7 |
| Escitalopram 20 mg and Placebo (Orally, Once Daily) | -3.8 |
| Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) | -3.8 |
| Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) | -4.0 |
Sheehan Disability Scale (SDS): Family Subscale
The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. (NCT00807248)
Timeframe: Mean change from baseline to Week 8
| Intervention | Scores on a scale (Mean) |
|---|
| Placebo (Orally, Once Daily) | -2.8 |
| Escitalopram 20 mg and Placebo (Orally, Once Daily) | -4.0 |
| Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) | -3.9 |
| Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) | -4.1 |
Number of Participants Meeting Depression Remission Criteria
Depression remission defined as 3 consecutive weeks of HRSD-17 scores that on average, < or = 7 (NCT00930293)
Timeframe: Measured at baseline and weekly for up to 20 weeks of acute treatment
| Intervention | participants (Number) |
|---|
| Personalized Depression Care | 10 |
| Standard Depression Care | 15 |
Weeks to Depression Remission
"Kaplan-Meier survival analyses to determine time to depression remission (defined as average HRSD-17 score < or = 7 for three consecutive weeks).~Analyses run with the full intent to treat sample (censoring patients who dropped out at time of termination)" (NCT00930293)
Timeframe: Measured at baseline and weekly for up to 20 weeks of treatment
| Intervention | weeks (Mean) |
|---|
| Personalized Depression Care | 13.99 |
| Standard Depression Care | 11.59 |
Change in Beck Depression Inventory II (BDI-II) Scores
The BDI-II is the total score on the 21-question Beck Depression Inventory II questionnaire. Scores range from 0 to 63 with higher scores indicating worse symptoms of depression. (NCT01214044)
Timeframe: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)
| Intervention | units on scale (scores) (Mean) |
|---|
| Study Drug | -3.3 |
Change in Hamilton Depression Rating Scale (HAM-D) Scores
The HAM-D is the total score on the 21-question Hamilton Depression Rating Scale. Scores range from 0 to 53 with higher scores indicating worse symptoms of depression. (NCT01214044)
Timeframe: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)
| Intervention | units on scale (scores) (Mean) |
|---|
| Study Drug | -2.3 |
Change in Phase Angle Difference (PAD)
The PAD is the time interval (number of hours) between the Dim Light Melatonin Onset (DLMO) and the average midpoint of sleep during the prior week. Larger PADs indicate a longer time interval between the DLMO and midpoint of sleep. A negative change in PAD value indicates a shortening of the time interval from Study Visit 3 to Study Visit 11. (NCT01214044)
Timeframe: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)
| Intervention | hours (Mean) |
|---|
| Study Drug | -0.6 |
Change in Dim Light Melatonin Onset
"The Dim Light Melatonin Onset (DLMO) is the time of the onset of melatonin secretion under dim light conditions using the equivalent thresholds of 10 pg/ml in plasma and 3 pg/ml in saliva. It is a marker of biological time. Data are provided in decimal and military time (e.g., 9:30 pm equals 21.50).~This measure is used to determine if there was a change in the time of the dim light melatonin onset (DLMO) before treatment with escitalopram (at Study Visit 3) and after treatment with escitalopram (at Study Visit 11)." (NCT01214044)
Timeframe: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)
| Intervention | decimal military time (hours) (Mean) |
|---|
| Baseline DLMO | Post-escitalopram DLMO |
|---|
| Study Drug | 21.17 | 20.77 |
Early and Sustained (Antidepressant) Response (ESR) Rate
Early and Sustained Response (ESR) is defined as a MADRS total score reduction from Baseline of 50% or more and a MADRS total score ≤16 at Week 2, Week 3, Week 4, and Week 6. (NCT01312922)
Timeframe: From (end of) Week 2 visit to (end of) Week 6 visit
| Intervention | Participants (Count of Participants) |
|---|
| PNB01 | 17 |
| Citalopram | 17 |
| Pipamperone | 17 |
Asthma Control Questionnaire (ACQ)
The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). (NCT01324700)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| High Severity: Escitalopram | 1.15 |
| High Severity: Placebo | 1.63 |
| Low Severity: Escitalopram | 1.39 |
| Low Severity: Placebo | 1.23 |
Hamilton Rating Scale for Depression (HRSD)
The patient is rated by a clinician on 17 items that measure depressive symptom severity. The total score is calculated by summing the responses across all items. Lower scores (closer to 0) indicate the absence of depressive symptoms, while higher scores indicate the presence of depressive symptoms. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2 (0 = not present; 2 = severe). The scale range of scores is 0-52. (NCT01324700)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| High Severity: Escitalopram | 10.08 |
| High Severity: Placebo | 14.38 |
| Low Severity: Escitalopram | 10.39 |
| Low Severity: Placebo | 9.31 |
Change in Symptoms of NES
Outcome of treatment will be measured by self report questionnaire, the Night Eating Symptom Scale ( higher score indicates worse symptoms). The percentage of calories consumed after dinner was estimated by recall at each treatment visit, as compared to their baseline % of intake after dinner, which was calculated through food diaries. The number of nocturnal ingestions (waking during the night and eating) per week was also recalled at each treatment visit. (NCT01401595)
Timeframe: 12 weeks
| Intervention | percentage of calories after dinner (Mean) |
|---|
| baseline %calories consumed after dinner | treatment end %calories after dinner |
|---|
| Controls | 11.8 | NA |
,| Night Eating Syndrome Open Label Escitalopram Treatment | 46.1 | 17.4 |
Night Eating Symptoms
"The responses on the Night Eating Symptom Scale (NESS) will be examined over time.~Subjects will complete the NESS at their baseline visit, and at every treatment visit thereafter. The Night Eating Symptom Scale-II (NESS-II) (Lundgren, Allison, Vinai, & Gluck, 2012) is a 14-item questionnaire (possible range of 0-56, with higher scores indicating more severe symptoms) that assesses the presence of NES features over the course of the previous week. The NESS will indicate whether or not escitalopram is having an effect on our participants' night eating symptoms." (NCT01401595)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| Baseline Night Eating Symptom Scale | treatment end night eating symptom scale |
|---|
| Controls | NA | NA |
,| Night Eating Syndrome Open Label Escitalopram Treatment | 30.2 | 15.2 |
Nocturnal Ingestions
Number of nocturnal ingestions (waking and having something to eat) were reported at each visit. (NCT01401595)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| baseline nocturnal ingestions/week | treatment end nocturnal ingestions/week |
|---|
| Controls | 0.0 | NA |
,| Night Eating Syndrome Open Label Escitalopram Treatment | 5.8 | 1.2 |
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10
The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement. (NCT01473381)
Timeframe: Baseline to Week 10
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| Placebo | -14.76 |
| Vilazodone 20 mg/Day | -17.33 |
| Vilazodone 40 mg/Day | -17.58 |
| Citalopram 40 mg/Day | -17.50 |
Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response
The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms. (NCT01473381)
Timeframe: Baseline to Week 10
| Intervention | Percentage of participants (Number) |
|---|
| Placebo | 26.3 |
| Vilazodone 20 mg/Day | 29.9 |
| Vilazodone 40 mg/Day | 33.5 |
| Citalopram 40 mg/Day | 31.1 |
Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score
"The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: Considering your total clinical experience with this population, how mentally ill is the patient at this time? The patient is rated on the following 7-point scale: 1-normal, not at all ill, 2-borderline ill, 3-mildly ill, 4-moderately ill, 5-markedly ill, 6-severely ill, 7-among the most extremely ill patients. A higher score indicates more mental illness. A negative change score indicates improvement." (NCT01473381)
Timeframe: Baseline to Week 10
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| Placebo | -1.53 |
| Vilazodone 20 mg/Day | -1.88 |
| Vilazodone 40 mg/Day | -1.86 |
| Citalopram 40 mg/Day | -1.88 |
Retention as Assessed by Number of Participants Remaining in Treatment
(NCT01535573)
Timeframe: 9 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Citalopram Low Dose | 13 |
| Citalopram High Dose | 23 |
| Placebo | 24 |
Proportion of Cocaine-positive Urines Per Week
Mean proportion of cocaine-positive urines per week, averaged across 9 weeks, is reported. Urine was collected three times each week over 9 weeks. Missing data is imputed as cocaine use. (NCT01535573)
Timeframe: 9 weeks
| Intervention | proportion of cocaine urines per week (Mean) |
|---|
| Citalopram Low Dose | 0.85 |
| Citalopram High Dose | 0.8 |
| Placebo | 0.85 |
Number of Participants With Cocaine-negative Urines Collected During Treatment Period
Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use. (NCT01535573)
Timeframe: 9 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Citalopram Low Dose | 14 |
| Citalopram High Dose | 26 |
| Placebo | 27 |
Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test
Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use. (NCT01535573)
Timeframe: 9 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Citalopram Low Dose | 0 |
| Citalopram High Dose | 4 |
| Placebo | 2 |
Friedreich Ataxia Rating Scale (FARS)
A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease. (NCT01716221)
Timeframe: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)
| Intervention | points (Number) |
|---|
| Baseline - Unblinded on Buproprion and Citalopram | 43 |
| Citalopram (Week 5) | 41 |
| OFF - Bupropion Placebo + Citalopram Placebo (Week 10) | 47 |
| Bupropion Only (Week 15) | 42 |
| Bupropion + Citalopram (Week 20) | 45 |
Comparison of FARS and ICARS
Differences between FARS - ICARS at each treatment interval (NCT01716221)
Timeframe: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)
| Intervention | points (Number) |
|---|
| Baseline - Unblinded on Buproprion and Citalopram | 1 |
| Citalopram (Week 5) | -6 |
| OFF - Bupropion Placebo + Citalopram Placebo (Week 10) | 1 |
| Bupropion Only (Week 15) | 12 |
| Bupropion + Citalopram (Week 20) | 6 |
International Cooperative Ataxia Rating Scale (ICARS)
The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease. (NCT01716221)
Timeframe: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion)
| Intervention | units (Number) |
|---|
| Bupropion & Citalopram | 39 |
| Bupropion & Placebo | 30 |
| Placebo & Citalopram | 47 |
| Placebo & Placebo | 46 |
| Baseline | 42 |
Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale is a 21 item questionnaire scored each item on a scale of 0 to 3 or 5. The max score is 66. Higher scores indicate worsened depression. All items are summed together to give a total score. A total score of 0-7 is considered normal, while total scores greater than 20 are indicative of moderate or greater depression. (NCT01716221)
Timeframe: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)
| Intervention | units on a scale (Number) |
|---|
| Baseline - Unblinded on Buproprion and Citalopram | 7 |
| Citalopram (Week 5) | 10 |
| OFF - Bupropion Placebo + Citalopram Placebo (Week 10) | 2 |
| Bupropion Only (Week 15) | 3 |
| Bupropion + Citalopram (Week 20) | 4 |
fMRI Brain Activation in Right Inferior Frontal Gyrus
Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score. (NCT02080832)
Timeframe: Baseline
| Intervention | Percent of significant voxels in cluster (Number) |
|---|
| Citalopram (20mg or 40mg) | 83 |
| Placebo | 0 |
Cocaine Use/Treatment Effectiveness Score (TES)
Number of benzoylecgonine negative urines divided by the total number of urines collected (NCT02080832)
Timeframe: 8 weeks of treatment
| Intervention | percentage of negative urines (Number) |
|---|
| Medication (Citalopram 20mg) | 6.6 |
| Placebo | 8.3 |
| Medication (Citalopram 40mg) | 29 |
fMRI Brain Activation in Right Precentral Gyrus
Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score. (NCT02080832)
Timeframe: Baseline
| Intervention | percent of significant voxels in cluster (Number) |
|---|
| Citalopram (20mg or 40mg) | 9 |
| Placebo | 0 |
fMRI Brain Activation in Right Orlandic Operculum
Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score. (NCT02080832)
Timeframe: Baseline
| Intervention | percent of significant voxels in cluster (Number) |
|---|
| Citalopram (20mg or 40mg) | 8 |
| Placebo | 0 |
Number of Remission From Major Depressive Episode Events
Remission from major depressive episode as assessed by 17-item Hamilton Depression Rating Scale. (NCT02137369)
Timeframe: 12 weeks
| Intervention | number of events (Number) |
|---|
| SSRI | 15 |
| Cognitive Behavioral Therapy | 4 |
Number of Response to Treatment Events
Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks (NCT02137369)
Timeframe: 12 weeks
| Intervention | number of events (Number) |
|---|
| SSRI | 21 |
| Cognitive Behavioral Therapy | 5 |
Amyloid Beta Levels in CSF
Change in the level of Amyloid Beta peptides (Amyloid Beta 42 and Amyloid Beta 40) in the CSF between the measurement at baseline and the measurement after exposure with escitalopram. (NCT02161458)
Timeframe: 2 - 8 Weeks (we used week 8 minus baseline and week 2 minus baseline)
| Intervention | pg/mL (Mean) |
|---|
| Ab 42 in CSF | Ab 40 in CSF |
|---|
| Escitalopram 20mg for 2 Weeks | -12.7 | 46.27 |
,| Escitalopram 20mg for 8 Weeks | -25.63 | -41.82 |
,| Escitalopram 30mg for 8 Weeks | -22.73 | -152.64 |
,| Placebo (Sugar Pill) | 6.74 | 197.36 |
Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
"C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. It consists of 10 items, each with two possible answers (yes/no). Suicidal ideation was interpreted if yes answer at any time during treatment to any one of the five suicidal ideation questions (item 1-5) on the C-SSRS. Suicidal behavior was interpreted if a yes answer at any time during treatment to any one of the five suicidal behavior questions (item 6-10) on the C-SSRS. Suicidal ideation or behavior is interpreted if a yes answer at any time during treatment to any one of the ten suicidal ideation and behavior questions (item 1-10) on the C-SSRS. Number of participants with at least one on-treatment C-SSRS assessment were analyzed. Only those participants with data available at the specified time points were analyzed." (NCT02191397)
Timeframe: Baseline and up to Taper visit (Week 9)
| Intervention | Participants (Number) |
|---|
| Suicidal Ideation or Behavior | Suicidal Ideation | Suicidal Behavior | Self-Injurious Behavior, no suicidal attempt |
|---|
| Bupropion XL | 50 | 50 | 2 | 1 |
,| Escitalopram | 43 | 43 | 1 | 1 |
Number of Participants With Urinalysis Data Outside the Normal Range
Urine samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Number of participants with urine specific gravity and potential of hydrogen (pH) outside (higher or lower) the normal range are presented. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10
| Intervention | Participants (Number) |
|---|
| Urine specific gravity, high,Screening, n=265, 255 | Urine specific gravity, low,Screening, n=265, 255 | Urine specific gravity,high, Week 8, n=171, 173 | Urine specific gravity,low, Week 8, n=171, 173 | Urine specific gravity, high, Taper, n=18, 28 | Urine specific gravity, low, Taper, n=18, 28 | Urine specific gravity, high, Follow-up, n=7, 14 | Urine specific gravity, low, Follow-up, n=7, 14 | Urine pH, high, Screening, n=265, 266 | Urine pH, low, Screening, n=265, 266 | Urine pH, high, Week 8, n=172, 178 | Urine pH, low, Week 8, n=172, 178 | Urine pH, high, Taper, n=18, 28 | Urine pH, low, Taper, n=18, 28 | Urine pH, high, Follow-up, n=7, 14 | Urine pH, low, Follow-up, n=7, 14 |
|---|
| Bupropion XL | 20 | 1 | 9 | 0 | 0 | 0 | 0 | 0 | 7 | 37 | 5 | 23 | 0 | 2 | 0 | 2 |
,| Escitalopram | 12 | 1 | 7 | 1 | 0 | 1 | 3 | 0 | 18 | 28 | 9 | 20 | 1 | 2 | 0 | 2 |
Number of Participants With Vital Sign Parameters Outside the Clinical Concern Range
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were taken at Screening (within 14 days prior to dosing), randomization visit (Week 0) and at Weeks 1, 2, 4, 6, 8, Taper visit (Week 9) and Follow-up visit (Week 10). SBP <30 or >170 millimeter of mercury (mmHg); DBP <20 or >110 mmHg and heart rate <40 or >120 beats per minute (bpm) were considered as values outside of clinical concern range and were presented as 'High' or 'Low' values. Number of participants with vital signs outside of clinical concern range at any post-Baseline visit are presented. Only those participants with data available at the specified time points were analyzed. (NCT02191397)
Timeframe: Up to Week 10
| Intervention | Participants (Number) |
|---|
| SBP, high, Any visit post-Baseline | SBP, low,Any visit post-Baseline | DBP, high, Any visit post-Baseline | DBP, low, Any visit post-Baseline | HR, high, Any visit post-Baseline | HR, low, Any visit post-Baseline |
|---|
| Bupropion XL | 1 | 0 | 0 | 0 | 0 | 0 |
,| Escitalopram | 0 | 0 | 0 | 0 | 1 | 0 |
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10
| Intervention | Picograms (Mean) |
|---|
| MCH, Week 8, n=176, 183 | MCH, Taper, n=13, 16 | MCH, Follow-up, n=10, 8 |
|---|
| Bupropion XL | -0.032 | 0.269 | -0.050 |
,| Escitalopram | 0.049 | 0.262 | -0.250 |
Change From Baseline in Changes in Sexual Function Questionnaire (CSFQ)
CSFQ is a questionnaire about sexual activity and sexual function (sexual intercourse, masturbation, sexual fantasies and other activity). CSFQ is a gender-specific questionnaire. Both male and female versions consist of 14 items, each with 5 possible answers. CSFQ has a score in a range of 14 to 70. Higher score indicates higher sexual activity and sexual function. Value at Day 0 (Week 0) was considered as Baseline value. Change from Baseline at Week 8 was calculated by subtracting the Baseline score from the specific post-Baseline score. Only those participants with data available at the specified time points were analyzed. (NCT02191397)
Timeframe: Baseline (Day 0) and Week 8
| Intervention | Scores on a scale (Mean) |
|---|
| Bupropion XL | 3.0 |
| Escitalopram | 0.9 |
Mean Change in Hamilton Depression Rating Scale - 17 (HAMD-17) Total Score From Baseline to End of Acute Treatment Phase (Week 8)
HAMD-17 is used to assess the severity of depression and symptom improvement. It consisted of 17 questions. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Change from Baseline was calculated by subtracting the Baseline total score (at Day 0, Week 0) from Week 8 observed total score. The Per Protocol (PP) Population is defined as all randomized participants in the Intent-To-Treat (ITT) Population who do not meet criteria of a major protocol deviation, with overall compliance of active drug for acute treatment phase in the range of 75%-125% and complete the first 6 weeks treatment and has HAMD-17 assessment at/after week 6 (that is >=35 days). All participants in the PP population were included in the mixed model repeated measures analysis. Only those participants with data available at the specified time point were analyzed. (NCT02191397)
Timeframe: Baseline (Week 0) and Week 8
| Intervention | Scores on a scale (Least Squares Mean) |
|---|
| Bupropion XL | -14.5 |
| Escitalopram | -15.4 |
Response Rate Based on HAMD-17 Total Score
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Response was defined as decrease in HAMD-17 total scores at end of acute treatment phase (Week 8) relative to Baseline by at least 50%. Non-responder Imputation was used in calculation of rates. (NCT02191397)
Timeframe: Up to Week 8
| Intervention | Percentage of Participants (Number) |
|---|
| Bupropion XL | 69.6 |
| Escitalopram | 72.9 |
Sustained Remission Rate Based on HAMD-17 Total Score
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Sustained remission was defined as remission at end of acute treatment phase and an earlier visit and non-missing HAMD-17 total scores at all visits between these two visits <=8. (NCT02191397)
Timeframe: Up to Week 8
| Intervention | Percentage of Participants (Number) |
|---|
| Bupropion XL | 25.5 |
| Escitalopram | 28.6 |
Sustained Response Rate Based on HAMD-17 Total Score
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Sustained response was defined as response at end of acute treatment phase and an earlier visit and the decrease from Baseline in non-missing HAMD-17 total scores at all visits between these two visits by at least 40%. (NCT02191397)
Timeframe: Up to Week 8
| Intervention | Percentage of Participants (Number) |
|---|
| Bupropion XL | 51.6 |
| Escitalopram | 56.3 |
"Percentage of Participants With a Clinical Global Impression Global Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved) at Weeks 1, 2, 4, 6 and 8"
"For CGI-I rating, the raters indicated their assessment of the participant's total improvement or worsening compared to the participant's condition at the Baseline visit, whether or not the improvement or worsening was thought to be treatment related. Scores ranges from 0 to 7 where 0 represents Not assessed, and the remaining values 1-7 represent Very much improved (1) to Very much worse (7). Participants with score 0 were excluded from analysis. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points." (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8
| Intervention | Percentage of Participants (Number) |
|---|
| Week 1, n=184, 199 | Week 2, n=182, 199 | Week 4, n=184, 198 | Week 6, n=183, 197 | Week 8, n=176, 188 |
|---|
| Bupropion XL | 6 | 21.4 | 38.6 | 67.8 | 80.7 |
,| Escitalopram | 7.5 | 22.1 | 52.5 | 71.6 | 83.5 |
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10
| Intervention | International Units per liter (IU/L) (Mean) |
|---|
| ALT, Week 8, n=176, 183 | ALT, Taper, n=12, 16 | ALT, Follow-up, n=8, 12 | ALP, Week 8, n=176, 181 | ALP, Taper, n=12, 15 | ALP, Follow-up, n=7, 12 | AST, Week 8, n=176, 183 | AST, Taper, n=12, 16 | AST, Follow-up, n=8, 12 | GGT, Week 8, n=175, 181 | GGT, Taper, n=12, 15 | GGT, Follow-up, n=7, 12 | LD, Week 8, n=176, 182 | LD, Taper, n=13, 13 | LD, Follow-up, n=8, 10 |
|---|
| Bupropion XL | 2.254 | 7.993 | -7.337 | 1.866 | 3.674 | 5.643 | 0.330 | 3.193 | 0.925 | 0.688 | 1.403 | -2.029 | 1.292 | 14.463 | 11.037 |
,| Escitalopram | 1.315 | -1.812 | 5.938 | 0.407 | 3.480 | -3.953 | 1.099 | 0.381 | 2.867 | -0.694 | -3.133 | 3.916 | 2.879 | -8.092 | -4.150 |
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10
| Intervention | Millimole per liter (mmol/L) (Mean) |
|---|
| Calcium, Week 8, n=173, 183 | Calcium, Taper, n=12, 12 | Calcium, Follow-up, n=8, 11 | Chloride, Week 8, n=173, 182 | Chloride, Taper, n=10, 13 | Chloride, Follow-up, n=8, 8 | Cholesterol, Week 8, n=175, 181 | Cholesterol, Taper, n=12, 14 | Cholesterol, Follow-up, n=9, 11 | Glucose, Week 8, n=173, 181 | Glucose, Taper, n=12, 16 | Glucose, Follow-up, n=9, 11 | Potassium, Week 8, n=173, 182 | Potassium, Taper, n=10, 13 | Potassium, Follow-up, n=8, 8 | Sodium, Week 8, n=173, 182 | Sodium, Taper, n=10, 13 | Sodium, Follow-up, n=8, 8 | Triglycerides, Week 8, n=175, 181 | Triglycerides, Taper, n=13, 15 | Triglycerides, Follow-up, n=9, 11 | Urea, Week 8, n=174, 183 | Urea, Taper, n=12, 16 | Urea, Follow-up, n=8, 11 |
|---|
| Bupropion XL | -0.017 | -0.019 | -0.060 | 0.259 | -0.498 | -0.287 | -0.122 | 0.022 | -0.124 | -0.051 | 0.352 | -0.194 | -0.021 | -0.114 | -0.110 | -0.205 | -0.611 | -0.175 | 0.003 | -0.032 | 0.637 | -0.068 | 0.517 | 0.687 |
,| Escitalopram | -0.020 | 0.012 | -0.060 | -0.293 | -0.566 | -0.178 | 0.051 | 0.082 | -0.122 | -0.050 | 0.106 | 0.025 | 0.009 | 0.046 | 0.036 | -0.178 | 0.978 | 0.770 | 0.022 | 0.574 | 0.181 | 0.015 | -0.269 | -0.419 |
Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Weeks 1, 2, 4, 6 and 8
"CGI-S records the severity of illness at specific time points, with a range of responses from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants with zero values (0) representing Not assessed were excluded from analysis. Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was obtained by subtracting the Baseline value from the specific post-Baseline value. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points." (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8
| Intervention | Scores on a scale (Least Squares Mean) |
|---|
| Week 1, n=184, 199 | Week 2, n=182, 199 | Week 4, n=184, 198 | Week 6, n=183, 197 | Week 8, n=176, 188 |
|---|
| Bupropion XL | -0.3 | -0.7 | -1.1 | -1.6 | -2.1 |
,| Escitalopram | -0.4 | -0.8 | -1.3 | -1.7 | -2.2 |
Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score (Sum of Scores of Items 10, 11, 12, 13, 15 and 17) at Weeks 1, 2, 4, 6 and 8
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Anxiety/Somatization subscale score was derived as sum of scores of items 10, 11, 12, 13, 15 and 17 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 18 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8
| Intervention | Scores on a scale (Least Squares Mean) |
|---|
| Week 1, n=184, 199 | Week 2, n=182, 199 | Week 4, n=184, 198 | Week 6, n=183, 197 | Week 8, n=176, 188 |
|---|
| Bupropion XL | -1.3 | -2.0 | -3.0 | -4.0 | -4.8 |
,| Escitalopram | -1.1 | -2.4 | -3.4 | -4.4 | -5.1 |
Change From Baseline in HAMD-17 Depressed Mood Subscale Score (Score of Item 1) at Weeks 1, 2, 4, 6 and 8
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Depressed Mood Subscale is a factor score of item-1 (Depressed Mood) of HAMD-17 scale. This subscale has a score in a range of 0 (absence of depressed mood feelings) to 4 (when participants report virtually only these feeling states in his/her spontaneous verbal and non-verbal communicationtotal score). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8
| Intervention | Scores on a scale (Least Squares Mean) |
|---|
| Week 1, n=184, 199 | Week 2, n=182, 199 | Week 4, n=184, 198 | Week 6, n=183, 197 | Week 8, n=176, 188 |
|---|
| Bupropion XL | -0.4 | -0.7 | -1.1 | -1.5 | -1.9 |
,| Escitalopram | -0.4 | -0.8 | -1.3 | -1.6 | -1.9 |
Change From Baseline in HAMD-17 Retardation Subscale Score (Sum of Scores of Items 1, 7, 8 and 14) at Weeks 1, 2, 4, 6 and 8
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Retardation subscale score was derived as sum of scores of items 1, 7, 8 and 14 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 14 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8
| Intervention | Scores on a scale (Least Squares Mean) |
|---|
| Week 1, n=184, 199 | Week 2, n=182, 199 | Week 4, n=184, 198 | Week 6, n=183, 197 | Week 8, n=176, 188 |
|---|
| Bupropion XL | -1.0 | -1.8 | -2.9 | -3.9 | -4.7 |
,| Escitalopram | -1.0 | -2.0 | -3.1 | -3.9 | -4.9 |
Change From Baseline in HAMD-17 Sleep Disorder Subscale Score (Sum of Scores of Items 4, 5 and 6) at Weeks 1, 2, 4, 6 and 8
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Sleep Disorder subscale score was derived as sum of scores of items 4, 5 and 6 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 6 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8
| Intervention | Scores on a scale (Least Squares Mean) |
|---|
| Week 1, n=184, 199 | Week 2, n=182, 199 | Week 4, n=184, 198 | Week 6, n=183, 197 | Week 8, n=176, 188 |
|---|
| Bupropion XL | -0.6 | -0.8 | -1.4 | -1.8 | -2.3 |
,| Escitalopram | -0.7 | -1.2 | -1.6 | -2.0 | -2.4 |
Change From Baseline in Hematocrit at the Indicated Time Points
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10
| Intervention | Proportion of red blood cells in blood (Mean) |
|---|
| Hematocrit, Week 8, n=176, 183 | Hematocrit, Taper, n=13, 16 | Hematocrit, Follow-up, n=10, 8 |
|---|
| Bupropion XL | 0.0016 | -0.0051 | -0.0076 |
,| Escitalopram | -0.0044 | 0.0017 | 0.0051 |
Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10
| Intervention | Gram per Liter (G/L) (Mean) |
|---|
| Hemoglobin, Week 8, n=176, 183 | Hemoglobin, Taper, n=13, 16 | Hemoglobin, Follow-up, n=10, 8 | Total protein, Week 8, n=174, 183 | Total protein, Taper, n=12, 15 | Total protein, Follow-up, n=8, 12 | Albumin, Week 8, n=175, 183 | Albumin, Taper, n=12, 15 | Albumin, Follow-up, n=8, 12 | MCHC, Week 8, n=176, 183 | MCHC, Taper, n=13, 16 | MCHC, Follow-up, n=10, 8 |
|---|
| Bupropion XL | -0.22 | -1.54 | -3.10 | -0.640 | 1.197 | -4.650 | -0.254 | -0.086 | -1.925 | -0.09 | 0.54 | -2.10 |
,| Escitalopram | -1.16 | 1.38 | 0.38 | -0.891 | 2.000 | -1.227 | -0.678 | -0.027 | -1.577 | 0.76 | 2.25 | -2.88 |
Remission Rate Based on HAMD-17 Total Score
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Remission was defined as HAMD-17 total scores at end of acute treatment phase (Week 8) <=7. (NCT02191397)
Timeframe: Up to Week 8
| Intervention | Percentage of Participants (Number) |
|---|
| Bupropion XL | 39.7 |
| Escitalopram | 47.2 |
Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10
| Intervention | Femtoliter (Mean) |
|---|
| MCV, Week 8, n=176, 183 | MCV, Taper, n=13, 16 | MCV, Follow-up, n=10, 8 |
|---|
| Bupropion XL | 4.668 | 0.508 | 0.320 |
,| Escitalopram | -0.090 | 0.181 | 0.287 |
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Weeks 1, 2, 4, 6 and 8
MADRS is a 10-point rating scale. Each item is scored on a scale of 0-6, with a total score range of 0-60. Higher score indicates worst symptoms. This scale is mainly used to assess the efficacy of antidepressant treatment. The ratings were based on the signs and symptoms during the preceding week prior to the visit. Values at Day0, Week 0 was considered as Baseline value. The observed MADRS total score was considered as missing if any item is missing. Change from Baseline in MADRS was obtained by subtracting the Baseline value from the specific post-Baseline value. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8
| Intervention | Scores on a scale (Least Squares Mean) |
|---|
| Week 1, n=184, 199 | Week 2, n=182, 199 | Week 4, n=184, 198 | Week 6, n=183, 196 | Week 8, n=176, 188 |
|---|
| Bupropion XL | -3.6 | -7.0 | -11.2 | -15.5 | -18.6 |
,| Escitalopram | -3.8 | -8.3 | -12.4 | -16.3 | -19.5 |
Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10
| Intervention | 10^12 cells per liter (Mean) |
|---|
| RBC Count, Week 8, n=176, 183 | RBC Count, Taper, n=13, 16 | RBC Count, Follow-up, n=10, 8 |
|---|
| Bupropion XL | -0.009 | -0.088 | -0.132 |
,| Escitalopram | -0.049 | -0.007 | 0.036 |
Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10
| Intervention | Micromoles per liter (µmol/L) (Mean) |
|---|
| Total bilirubin, Week 8, n=175, 181 | Total bilirubin, Taper, n=12, 15 | Total bilirubin, Follow-up, n=8, 12 | Direct bilirubin, Week 8, n=175, 180 | Direct bilirubin, Taper, n=11, 15 | Direct bilirubin, Follow-up, n=8, 12 | Creatinine, Week 8, n=174, 183 | Creatinine, Taper, n=12, 15 | Creatinine, Follow-up, n=8, 11 |
|---|
| Bupropion XL | -0.812 | -3.457 | 0.382 | -0.072 | -1.554 | -0.102 | 7.507 | 6.675 | 4.237 |
,| Escitalopram | -0.071 | 1.198 | 0.338 | -0.006 | 0.654 | 0.382 | 0.307 | 0.880 | 1.618 |
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10
| Intervention | Giga cells per liter (GI/L) (Mean) |
|---|
| WBC count, Week 8, n=176, 183 | WBC count, Taper, n=13, 16 | WBC count, Follow-up, n=10, 8 | Total Neutrophils, Week 8, n=176, 183 | Total Neutrophils, Taper, n=13, 16 | Total Neutrophils, Follow-up, n=10, 8 | Lymphocytes, Week 8, n=176, 183 | Lymphocytes, Taper, n=13, 16 | Lymphocytes, Follow-up, n=10, 8 | Basophil, Week 8, n=176, 182 | Basophil, Taper, n=13, 16 | Basophil, Follow-up, n=10, 8 | Eosinophil, Week 8, n=176, 182 | Eosinophil, Taper, n=13, 16 | Eosinophil, Follow-up, n=10, 8 | Monocyte, Week 8, n=176, 182 | Monocyte, Taper, n=13, 16 | Monocyte, Follow-up, n=10, 8 | Platelet count, Week 8, n=176, 183 | Platelet count, Taper, n=13, 16 | Platelet count, Follow-up, n=10, 8 |
|---|
| Bupropion XL | -0.032 | 0.065 | -0.743 | 0.101 | 0.306 | -0.869 | -0.154 | -0.242 | 0.042 | 0.001 | 0.001 | -0.003 | -0.004 | -0.012 | -0.005 | 0.021 | -0.001 | 0.058 | 7.73 | 17.15 | 28.50 |
,| Escitalopram | -0.073 | -0.715 | 0.427 | -0.165 | -0.772 | 0.424 | 0.072 | 0.077 | 0.022 | 0.002 | 0.001 | -0.012 | 0.010 | 0.006 | 0.019 | 0.003 | -0.031 | 0.010 | 0.56 | 7.19 | 5.38 |
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious AE (SAE)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Participants who received any of the study treatment and had any non-serious AE or SAE were considered for analysis. Safety Population comprised of all participants who took at least one dose of the study medication. (NCT02191397)
Timeframe: Up to Week 10
| Intervention | Participants (Count of Participants) |
|---|
| Any non-serious AE | Any SAE |
|---|
| Bupropion XL | 151 | 10 |
,| Escitalopram | 150 | 11 |
Number of Participants With Electrocardiogram (ECG) Data Outside the Clinical Concern Range
ECG was recorded at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). PR interval <110 or >220 millisecond (msec); QRS interval <60 or >120 msec and corrected QT (QTc) interval >450 msec were considered as values outside of clinical concern range and were presented as 'High' or 'Low' values. Number of participants with ECG data outside of clinical concern range at any post-Baseline visit are presented. Only those participants with data available at the specified time points were analyzed. (NCT02191397)
Timeframe: Up to Week 10
| Intervention | Participants (Number) |
|---|
| PR interval, high, Any visit post-randomization | PR interval, low,Any visit post-randomization | QRS interval, high, Any visit post-randomization | QRS interval, low, Any visit post-randomization | QTc interval, high, Any visit post-randomization | QTc interval, low, Any visit post-randomization |
|---|
| Bupropion XL | 0 | 5 | 2 | 0 | 1 | 0 |
,| Escitalopram | 0 | 2 | 3 | 1 | 3 | 0 |
IL-6 Levels
IL6 levels were measured in participants by blood draw 6 weeks after the first dose was given. (NCT02389465)
Timeframe: up to week 6
| Intervention | pg/mL (Mean) |
|---|
| Healthy Control | 5.25 |
| Placebo | 18.24 |
| Escitalopram | 3.69 |
| Escitalopram + Celecoxib | 6.84 |
IL10 Levels
IL10 levels were measured in participants by blood draw 6 weeks after the first dose was given (NCT02389465)
Timeframe: up to 6 weeks
| Intervention | pg/mL (Mean) |
|---|
| Healthy Control | 4.21 |
| Placebo | 64.9 |
| Escitalopram | 12.24 |
| Escitalopram + Celecoxib | 18.56 |
Montgomery Asberg Depression Rating Scale (MADRS)
"This depression rating scale will be used to determine clinical outcome for depressed participants.~Scores range from 0-60. The higher the score, the worse the outcome (see below)~Normal: 0-6 Mild Depression: 7-19 Moderate Depression: 20-34 Severe Depression: 35+ Very Severe Depression: 60" (NCT02389465)
Timeframe: Week 6
| Intervention | Total Score (Sum of Points) (Mean) |
|---|
| Healthy Control | 1.27 |
| Placebo | 19.14 |
| Escitalopram | 14.04 |
| Escitalopram + Celecoxib | 12.93 |
Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks
Instrument developed to assess functional impairment in three inter-related domains; work/school, social and family life. Items are scored on a 0 - 10 point scale. Higher scores indicate more functional impairment. (NCT02579343)
Timeframe: Assessed at baseline and 6 weeks.
| Intervention | units on a scale (Mean) |
|---|
| Work / School Domain | Social Life Domain | Family Life Domain |
|---|
| Auricular Acupuncture + Lexipro | -3.57 | -2.29 | -3.42 |
,| Sham Auricular Acupuncture + Lexapro | -1.5 | -1.0 | -0.17 |
Change of Mean Score of the Behavioral Health Measure-20 Between Baseline and End of Study
The Behavioral Health Measure - 20 (BHM-20) is a 20-item client-report questionnaire that assesses the three phases of behavioral health: (a) well-being (distress, life satisfaction, motivation), (b) psychological symptoms (depression, anxiety, panic disorder, mood swings associated with bipolar disorder, eating disorder, alcohol/drug abuse, suicidality, risk of violence), and (c) life functioning (work/school, intimate relationships, social relationships, life enjoyment). The BHM-20 assesses the most frequently seen problems in outpatient psychotherapy. Scores range from 0-4. Lower scores indicate more distress. (NCT02579343)
Timeframe: Assessed at Baseline and After Treatment, Approximately 6 Weeks later.
| Intervention | units on a scale (Mean) |
|---|
| Auricular Acupuncture + Lexipro | 0.89 |
| Sham Auricular Acupuncture + Lexapro | 0.47 |
Adherence Consistency
To determine whether RT2CK17 + escitalopram results in greater consistency of adherence relative to placebo + escitalopram as measured by percentage of doses taken on schedule within 25% of the expected time interval, defined as +/- 6 hours from the participant's breakfast time (NCT03388164)
Timeframe: 8 weeks
| Intervention | percentage of pills taken on time (Mean) |
|---|
| Escitalopram + RT2CK17 | 89.8 |
| Escitalopram + Placebo | 93.6 |
Rate of Adherence
To determine whether RT2CK17 + escitalopram results in higher rates of medication adherence relative to placebo + escitalopram as measured by percentage pill count (NCT03388164)
Timeframe: 8 weeks
| Intervention | percentage of pills taken (Mean) |
|---|
| Escitalopram + RT2CK17 | 93.5 |
| Escitalopram + Placebo | 97.6 |