Page last updated: 2024-11-11

vilazodone hydrochloride

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Cross-References

ID SourceID
PubMed CID6918313
CHEMBL ID1615374
CHEBI ID70705
SCHEMBL ID867358
MeSH IDM0560395

Synonyms (74)

Synonym
HY-14261
vilazodone (hydrochloride)
V0149
viibryd
vilazodone hydrochloride ,
emd-68843
sb-659746a
viibryd (tn)
vilazodone hydrochloride (usan)
D09699
163521-08-2
chebi:70705 ,
sb-659746-a
CHEMBL1615374
vilazodone hcl
emd 68 843
sb659746-a
u8htx2gk8j ,
2-benzofurancarboxamide, 5-(4-(4-(5-cyano-1h-indol-3-yl)butyl)-1-piperazinyl)-, hydrochloride (1:1)
5-(4-(4-(5-cyano-1h-indol-3-yl)butyl)piperazin-1-yl)benzofuran-2-carboxamide monohydrochloride
unii-u8htx2gk8j
vilazodone hydrochloride [usan]
S4259
vilazodone hydrochloride [vandf]
vilazodone hydrochloride [orange book]
5-{4-[4-(5-cyano-1h-indol-3-yl)butyl]piperazin-1-yl}benzofuran-2-carboxamide monohydrochloride
vilazodone hydrochloride [mi]
vilazodone hydrochloride [mart.]
vilazodone hydrochloride [who-dd]
5-{4-[4-(5-cyano-1h-indol-3-yl)butyl]piperazin-1-yl}-1-benzofuran-2-carboxamide hydrochloride
4-(2-carbamoyl-1-benzofuran-5-yl)-1-[4-(5-cyano-1h-indol-3-yl)butyl]piperazin-1-ium chloride
CS-0549
vilazodone monohydrochloride
SCHEMBL867358
CCG-213313
1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride
1-[4-(5-cyanoindol-3-yl)butyl]4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride
RPZBRGFNBNQSOP-UHFFFAOYSA-N
1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)piperazine hydrochloride
5-(4-(4-(5-cyano-1h-indol-3-yl)butyl)piperazin-1-yl)benzofuran-2-carboxamide hydrochloride
5-[4-[4-(5-cyano-1h-indol-3-yl)butyl]piperazin-1-yl]benzofuran-2-carboxamide hydrochloride
5-[4-[4-(5-cyanoindol-3-yl)butyl]piperazin-1-yl]benzofuran-2-carboxamide hydrochloride
AC-25885
AKOS024464039
sb659746a
sb 659746a
emd68843
emd 68843
J-525160
5-[4-[4-(5-cyano-1h-indol-3-yl)butyl]-1-piperazinyl]-2-benzofurancarboxamide hydrochloride
5-(4-[4-(5-cyano-3-indolyl)-butyl]-1-piperazinyl)-benzofuran-2carboxamide hydrochloride
AS-74699
vilazodone hydrochloride, >=98% (hplc)
2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1h-indol-3-yl)butyl]-1-piperazinyl]-, hydrochloride (1:1); 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1h-indol-3-yl)butyl]-1-piperazinyl]-, monohydrochloride (9ci); emd 68843; sb 659746a; viibryd; vilazodone hydroc
163521-08-2 (hcl)
mfcd00940014
vilazodonei
SW219887-1
Q27139037
5-(4-[4-(5-cyano-1h-indol-3-yl)butyl]piperazin-1-yl)benzofuran-2-carboxamide, hydrochloride
emd 68843;sb659746a
5-{4-[4-(5-cyano-1h-indol-3-yl)butyl]piperazin-1-yl}-1-benzofuran-2-carboximidic acid--hydrogen chloride (1/1)
DTXSID80936833
BCP11496
5-[4-[4-(5-cyano-1h-indol-3-yl)butyl]piperazin-1-yl]-1-benzofuran-2-carboxamide;hydrochloride
2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1h-indol-3-yl)butyl]-1-piperazinyl]-, hydrochloride (1:1)
vilazodonehydrochloride
4-(2-carbamoyl-1-benzofuran-5-yl)-1-(4-(5-cyano-1h-indol-3-yl)butyl)piperazin-1-ium chloride
vilazodone hydrochloride (mart.)
hydrochloride, vilazodone
5-(4-(4-(5-cyano-1h-indol-3-yl)butyl)piperazin-1-yl)-1-benzofuran-2-carboxamide hydrochloride
hcl, vilazodone
vilazodone.hcl
vilazodone.hcl, 1mg/ml in acetonitrile/water : 1/1

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Safety assessments included adverse events (AEs), physical examinations, clinical chemistry, electrocardiograms, and the Changes in Sexual Functioning Questionnaire."( A 1-year, open-label study assessing the safety and tolerability of vilazodone in patients with major depressive disorder.
Gallipoli, S; Kajdasz, DK; Reed, CR; Robinson, DS; Wamil, A; Whalen, H, 2011
)
0.37
" placebo for discontinuation because of an adverse event (AE) was 27 (95% CI 15-104)."( Vilazodone for major depressive disorder: a systematic review of the efficacy and safety profile for this newly approved antidepressant - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed?
Citrome, L, 2012
)
0.38
" Current pharmaceutical treatment options are limited in their success by modest effects and adverse events that often lead to discontinuation."( A review of the clinical efficacy, safety and tolerability of the antidepressants vilazodone, levomilnacipran and vortioxetine.
Deardorff, WJ; Grossberg, GT, 2014
)
0.4
" Weight increase and sexual dysfunction adverse events were low in both groups."( Efficacy and safety of vilazodone in major depressive disorder: a randomized, double-blind, placebo-controlled trial.
Chen, D; Croft, HA; Gommoll, C; Mathews, M; Nunez, R; Pomara, N, 2014
)
0.4
" 5, respectively), and vomiting (4 participants) occurred only in participants with severe hepatic impairment; other adverse events were roughly equivalent between groups."( Pharmacokinetics and Safety of Vilazodone in Hepatic Impairment.
Boinpally, R; Edwards, J; Gupta, S; Henry, D; Longstreth, J; Periclou, A,
)
0.13
" The most common adverse events (≥5% of vilazodone patients, twice the rate of placebo) were diarrhea, nausea, vomiting (vilazodone 40 mg/day only), and insomnia."( Efficacy and safety of vilazodone 20 and 40 mg in major depressive disorder: a randomized, double-blind, placebo-controlled trial.
Chen, D; Gommoll, C; Khan, A; Mathews, M; Nunez, R, 2015
)
0.42
" Treatment-emergent adverse events reported in ≥ 5% of vilazodone patients and at least twice the rate of placebo were nausea, diarrhea, dizziness, fatigue, delayed ejaculation, and erectile dysfunction."( Efficacy and Safety of Vilazodone in Patients With Generalized Anxiety Disorder: A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Trial.
Durgam, S; Forero, G; Gommoll, C; Mathews, M; Nunez, R; Sheehan, DV; Tang, X, 2016
)
0.43
" Although rates of overall adverse events and discontinuation due to adverse events were similar, RCTs reported several differences in specific adverse events."( Efficacy and safety of levomilnacipran, vilazodone and vortioxetine compared with other second-generation antidepressants for major depressive disorder in adults: A systematic review and network meta-analysis.
Gartlehner, G; Klerings, I; Schultes, MT; Teufer, B; Titscher, V; Wagner, G, 2018
)
0.48

Pharmacokinetics

ExcerptReferenceRelevance
" The pharmacokinetic parameters calculated were maximum plasma concentration (Cmax), time to maximum plasma concentration, area under the plasma concentration-time curve (AUC) from time zero to 24 h, AUC from time zero to the last measurable concentration, AUC from time zero to infinity estimated by linear trapezoidal rule and extrapolation, oral clearance, terminal elimination rate constant, elimination half-life (t½), free fraction in plasma, apparent free drug clearance, amount of vilazodone recovered in urine 0-96 h following drug administration, percent of dose recovered in urine over 96 h following drug administration, renal clearance and volume of distribution."( Pharmacokinetics of vilazodone in patients with mild or moderate renal impairment.
Adams, MH; Alcorn, H; Boinpally, R; Edwards, J; Longstreth, J, 2013
)
0.39
"Vilazodone pharmacokinetic parameters in renally impaired subjects were variable but not substantially different from healthy controls."( Pharmacokinetics of vilazodone in patients with mild or moderate renal impairment.
Adams, MH; Alcorn, H; Boinpally, R; Edwards, J; Longstreth, J, 2013
)
0.39
" Part 1 was an open-label pharmacokinetic assessment of a single 5-mg vilazodone dose with or without ketoconazole."( Influence of CYP3A4 induction/inhibition on the pharmacokinetics of vilazodone in healthy subjects.
Boinpally, R; Gad, N; Gupta, S; Periclou, A, 2014
)
0.4
" The upper limit of the 90% CIs for the vilazodone AUC and Cmax geometric mean ratios exceeded 125%."( Influence of CYP3A4 induction/inhibition on the pharmacokinetics of vilazodone in healthy subjects.
Boinpally, R; Gad, N; Gupta, S; Periclou, A, 2014
)
0.4
" In these phase 1, open-label, parallel-group, single-dose pharmacokinetic studies, vilazodone (20 mg) was administered to participants with mild, moderate, or severe hepatic impairment or individually matched healthy controls."( Pharmacokinetics and Safety of Vilazodone in Hepatic Impairment.
Boinpally, R; Edwards, J; Gupta, S; Henry, D; Longstreth, J; Periclou, A,
)
0.13
"A sensitive, rapid and simple liquid chromatographic-electrospray ionization tandem mass spectrometric (LC-ESI-MS-MS) method was developed for the quantitative determination of vilazodone in human plasma and for the study of the pharmacokinetic behavior of vilazodone in healthy Egyptian volunteers."( UPLC-MS-MS Method for the Determination of Vilazodone in Human Plasma: Application to a Pharmacokinetic Study.
El-Bagary, R; Fouad, M; Hashem, H; Tarek, S, 2016
)
0.43
" This study aims to load VLZ-phospholipid complex into self-assembled micelles forming VLZ-PL mixed micelles (VLZ-PL-MM), that can enhance VLZ solubility, improve its bioavailability and reduce the pharmacokinetic variability between the fed and fasting conditions."( Vilazodone-phospholipid mixed micelles for enhancing oral bioavailability and reducing pharmacokinetic variability between fed and fasted states.
Al-Mahallawi, AM; El Said, HS; Ghorab, DM; Lalatsa, A; Saddar El Leithy, E, 2022
)
0.72

Bioavailability

Vilazodone hydrochloride therapy should be initiated at a dosage of 10 mg once daily and incrementally adjusted over 14 days to the recommended target daily dose of 40 mg. For optimal bioavailability and effectiveness, it should be taken after a light or high-fat meal.

ExcerptReferenceRelevance
" Vilazodone hydrochloride therapy should be initiated at a dosage of 10 mg once daily and incrementally adjusted over 14 days to the recommended target daily dose of 40 mg; for optimal bioavailability and effectiveness, it should be taken after a light or high-fat meal."( Vilazodone: a novel antidepressant.
Choi, E; Ehret, MJ; Zmarlicka, M, 2012
)
1.29
" This HPLC-MS/MS method was successfully applied to a bioavailability comparison of two crystal forms of vilazodone hydrochloride (IV and XVII) in six healthy beagles using a single-dose, two-way crossover design."( Bioavailability comparison of a new form of vilazodone XVII to IV in beagles using liquid chromatography/mass spectrometry.
Ouyang, PK; Sun, LL; Wei, P; Zeng, LL; Zhou, F; Zou, Q, 2014
)
0.62
" This study aims to load VLZ-phospholipid complex into self-assembled micelles forming VLZ-PL mixed micelles (VLZ-PL-MM), that can enhance VLZ solubility, improve its bioavailability and reduce the pharmacokinetic variability between the fed and fasting conditions."( Vilazodone-phospholipid mixed micelles for enhancing oral bioavailability and reducing pharmacokinetic variability between fed and fasted states.
Al-Mahallawi, AM; El Said, HS; Ghorab, DM; Lalatsa, A; Saddar El Leithy, E, 2022
)
0.72

Dosage Studied

Vilazodone hydrochloride therapy should be initiated at a dosage of 10 mg once daily and incrementally adjusted over 14 days to the recommended target daily dose of 40 mg. For optimal bioavailability and effectiveness, it should be taken after a light or high-fat meal.

ExcerptRelevanceReference
" In behavioral studies, EMD 68843 produced antidepressant-like effects in the forced swimming test in both rats and mice but only within a narrow dosage range."( Behavioral and neurochemical effects of 5-(4-[4-(5-Cyano-3-indolyl)-butyl)-butyl]-1-piperazinyl)-benzofuran-2-carboxamide (EMD 68843): a combined selective inhibitor of serotonin reuptake and 5-hydroxytryptamine(1A) receptor partial agonist.
Cryan, JF; Dalvi, A; Lucki, I; Manning, DR; Page, ME; Saucy, B; Sullivan, A, 2002
)
0.31
" At the recommended dosage of 40 mg/day, vilazodone was effective in the short-term treatment of MDD in adults, as evidenced by significant improvements versus placebo on multiple measures of depression, including the Montgomery-Åsberg Depression Rating Scale (MADRS) and the 17-item Hamilton Rating Scale for Depression (HAM-D-17), in two pivotal, 8-week, randomized, double-blind, phase III studies."( Vilazodone: in major depressive disorder.
Frampton, JE, 2011
)
0.37
" Vilazodone hydrochloride therapy should be initiated at a dosage of 10 mg once daily and incrementally adjusted over 14 days to the recommended target daily dose of 40 mg; for optimal bioavailability and effectiveness, it should be taken after a light or high-fat meal."( Vilazodone: a novel antidepressant.
Choi, E; Ehret, MJ; Zmarlicka, M, 2012
)
1.29
" Adverse effects are mostly mild-moderate and most GI type AEs disappear in about one week, at a time when all patients are still on a clinically suboptimal daily dosage (10 mg/d during the first week)."( Evidence for the use of vilazodone in the treatment of major depressive disorder.
Lohoff, FW; Mandos, LA; Reinhold, JA; Rickels, K, 2012
)
0.38
" It has a narrow therapeutic dosing range whose upper boundary is close to that producing intolerable gastrointestinal and central nervous system adverse events."( Vilazodone hydrochloride, a combined SSRI and 5-HT1A receptor agonist for major depressive disorder.
Guay, DR, 2012
)
1.82
"To make an informed benefit-risk evaluation of a drug, a range of doses needs to be evaluated and its dose-response and exposure-response relationships for safety and effectiveness assessed during drug development (International Conference on Harmonisation E4)."( Is this the dose for you?: the role of modeling.
Bhattaram, A; Huang, SM; Mehrotra, N; Wang, Y, 2013
)
0.39
"These results suggest that up to a 50% decrease of vilazodone dosage should be considered when it is given in combination with strong CYP3A4 inhibitors; conversely, increasing the vilazodone dosage up to a maximum of 80 mg/d should be considered when it is given in combination with strong CYP3A4 inducers."( Influence of CYP3A4 induction/inhibition on the pharmacokinetics of vilazodone in healthy subjects.
Boinpally, R; Gad, N; Gupta, S; Periclou, A, 2014
)
0.4
"A stability-indicating liquid chromatographic method was developed employing the principles of quality by design (QbD) to quantify vilazodone hydrochloride (VLN) in pharmaceutical dosage form."( Development and Validation of a Stability-Indicating Liquid Chromatographic Method for Estimating Vilazodone Hydrochloride in Pharmaceutical Dosage Form Using Quality by Design.
Beg, S; Muni, S; Panda, SS; Ravi Kumar, VV; Sahu, SK, 2016
)
0.86
" In addition, increasing the dosage improved the efficacy of vortioxetine but worsened the tolerability."( Efficacy and tolerability of different doses of three new antidepressants for treating major depressive disorder: A PRISMA-compliant meta-analysis.
An, X; Fan, Y; Guo, L; He, H; Lyu, J; Ma, X; Wang, W; Zheng, J, 2018
)
0.48
" Typical adult dosing is titrated from an initial dose of 10 mg up to a maximum dose of 40 mg daily."( Serotonin Syndrome Associated With Vilazodone Overdose in a 22-Month-Old Treated With Dexmedetomidine.
Schaeffer, T; Schlichting, E; Strout, TD; Welter, C, 2021
)
0.62
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
antidepressantAntidepressants are mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions.
serotonin uptake inhibitorA compound that specifically inhibits the reuptake of serotonin in the brain. This increases the serotonin concentration in the synaptic cleft which then activates serotonin receptors to a greater extent.
serotonergic agonistAn agent that has an affinity for serotonin receptors and is able to mimic the effects of serotonin by stimulating the physiologic activity at the cell receptors. Serotonin agonists are used as antidepressants, anxiolytics, and in the treatment of migraine disorders.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
hydrochlorideA salt formally resulting from the reaction of hydrochloric acid with an organic base.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Bioassays (1)

Assay IDTitleYearJournalArticle
AID1908596Anti-depressant activity in ICR mouse assessed as reduction in immobility time at 30 mg/kg, po measured after 1 hr post treatment by tail suspension test2022European journal of medicinal chemistry, Jun-05, Volume: 236Discovery of novel dual RAGE/SERT inhibitors for the potential treatment of the comorbidity of Alzheimer's disease and depression.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (141)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's1 (0.71)18.2507
2000's13 (9.22)29.6817
2010's107 (75.89)24.3611
2020's20 (14.18)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 48.48

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index48.48 (24.57)
Research Supply Index5.18 (2.92)
Research Growth Index6.12 (4.65)
Search Engine Demand Index73.08 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (48.48)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials30 (20.55%)5.53%
Reviews30 (20.55%)6.00%
Case Studies14 (9.59%)4.05%
Observational1 (0.68%)0.25%
Other71 (48.63%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (27)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Multi-Center, Randomized, Double-Blind, Parallel-Group Study Evaluating The Sexual Functioning of Healthy Adults After Receiving Multiple-Dose Regimens of Vilazodone, Paroxetine, or Placebo [NCT02097147]Phase 1202 participants (Actual)Interventional2014-03-31Completed
A Phase 2, Multi-center, Multi-arm, Randomized, Placebo-controlled, Double-blind, Adaptive Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Potential Pharmacotherapeutic Interventions in Active-Duty Service Members and Veterans With PT [NCT05948579]Phase 2200 participants (Anticipated)Interventional2023-08-31Not yet recruiting
A Phase 2, Multi-center, Multi-arm, Randomized, Placebo-controlled, Double-blind, Adaptive Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Potential Pharmacotherapeutic Interventions in Active-Duty Service Members and Veterans With PT [NCT05422612]Phase 2600 participants (Anticipated)Interventional2023-11-02Recruiting
Double-Blind Switch Study of Vilazodone in the Treatment of Major Depressive Disorder Following Partial Response to or Inability to Tolerate a Generic SSRI [NCT01742832]Phase 279 participants (Actual)Interventional2013-05-31Completed
A Randomized, Double-blind, Placebo Controlled Study Assessing the Efficacy and Safety of Vilazodone 40 mg qd and Evaluating Genetic Biomarkers Associated With Treatment Response in Patients With Major Depressive Disorder (MDD) [NCT00683592]Phase 3481 participants (Actual)Interventional2008-03-31Completed
The Effects of Vilazodone on Glutamate in the Anterior Cingulate Cortex in Anxious Unipolar Depressives [NCT02028026]Phase 40 participants (Actual)Interventional2013-04-30Withdrawn(stopped due to Inability to recruit eligible subjects)
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies [NCT02893371]1,037,352 participants (Actual)Observational2016-09-30Completed
A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder [NCT00644358]Phase 3616 participants (Actual)Interventional2007-12-31Completed
A Randomized, Double-Blind, Active Controlled Clinical Trial of Switching to Vilazodone for Antidepressant-Associated Sexual Dysfunction [NCT01856127]Phase 44 participants (Actual)Interventional2013-01-31Terminated(stopped due to PI left institution)
A Randomized, Double-Blind, Placebo Controlled Study Assessing the Efficacy and Safety of Vilazodone and Discovering Genetic Markers Associated With Response in Patients With Major Depressive Disorder [NCT00285376]Phase 3410 participants (Actual)Interventional2006-02-28Completed
[NCT00290914]Phase 20 participants InterventionalCompleted
Vilazodone for Menopausal Hot Flashes: A Proof in Principle Study [NCT01680900]36 participants (Actual)Interventional2012-11-30Completed
Vilazodone for Separation Anxiety Disorder [NCT01999920]Phase 424 participants (Actual)Interventional2013-12-31Completed
Vilazodone in the Treatment of Social Anxiety Disorder: A Double Blind Study [NCT01712321]30 participants (Anticipated)Interventional2012-10-31Active, not recruiting
A Double-blind, Placebo-controlled Randomized Trial of Vilazodone in the Treatment of Posttraumatic Stress Disorder [NCT01715519]Phase 459 participants (Actual)Interventional2012-10-31Completed
A Pilot Study of Double-blind Comparison of Vilazodone to Paroxetine in Geriatric Depression [NCT01608295]Phase 465 participants (Actual)Interventional2012-07-31Completed
Vilazodone for Corticosteroid-Induced Memory Impairment [NCT01828515]Phase 224 participants (Actual)Interventional2012-12-31Completed
A Multicenter, Double-blind, Placebo- and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder [NCT02372799]Phase 3473 participants (Actual)Interventional2015-02-28Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study With Vilazodone in Patients With Major Depressive Disorder [NCT01573598]Phase 41,219 participants (Actual)Interventional2012-04-30Completed
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder [NCT01878292]Phase 3529 participants (Actual)Interventional2013-07-11Completed
An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder [NCT02436239]Phase 3330 participants (Actual)Interventional2015-05-02Completed
A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder. [NCT01629966]Phase 3680 participants (Actual)Interventional2012-06-30Completed
Vilazodone Treatment for Marijuana Dependence [NCT01574183]Phase 276 participants (Actual)Interventional2012-08-31Completed
A Double-blind, Placebo- and Active-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder [NCT01473381]Phase 41,162 participants (Actual)Interventional2011-12-31Completed
A Double-blind, Placebo-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder [NCT01473394]Phase 4518 participants (Actual)Interventional2011-12-31Completed
A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder. [NCT01844115]Phase 3415 participants (Actual)Interventional2013-04-30Completed
A Randomized, Double-Blind, 8-week Comparing Safety and Tolerability of Switching From Generic Selective Serotonin Reuptake Inhibitors (SSRIs) and Selective Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) to Three Different Dose Initiation Strate [NCT02015546]Phase 370 participants (Actual)Interventional2012-12-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00644358 (4) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT00644358 (4) [back to overview]Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
NCT00644358 (4) [back to overview]Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score
NCT00644358 (4) [back to overview]Clinical Global Impression - Improvement (CGI-I) Score
NCT00683592 (6) [back to overview]Change From Baseline to Week 8 in the HAM-A ( Hamilton Anxiety Rating Scale) Total Score
NCT00683592 (6) [back to overview]Change From Baseline to Week 8 in the HAM-D 17 (17-Item Hamilton Rating Scale for Depression) Total Score
NCT00683592 (6) [back to overview]Change From Baseline to Week 8 in the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score.
NCT00683592 (6) [back to overview]MADRS (Montgomery-Asberg Depression Rating Scale) Remission Rate at Week 8
NCT00683592 (6) [back to overview]MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate at Week 8
NCT00683592 (6) [back to overview]The CGI-I (Clinician's Global Impression of Improvement) Score at Week 8
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
NCT01473381 (3) [back to overview]Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10
NCT01473394 (3) [back to overview]Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8
NCT01473394 (3) [back to overview]Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8
NCT01473394 (3) [back to overview]Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate
NCT01574183 (3) [back to overview]Weekly Cannabis Use Sessions
NCT01574183 (3) [back to overview]Percent Marijuana-negative Urine Drug Screens (UDS)
NCT01574183 (3) [back to overview]Marijuana Craving and Withdrawal
NCT01608295 (4) [back to overview]UKU Side-effect Profile
NCT01608295 (4) [back to overview]Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)
NCT01608295 (4) [back to overview]Hamilton Depression Rating Scale (HDRS)
NCT01608295 (4) [back to overview]Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test
NCT01629966 (2) [back to overview]Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
NCT01629966 (2) [back to overview]Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
NCT01680900 (6) [back to overview]Percentage of Participants That Were Satisfied or Very Satisfied
NCT01680900 (6) [back to overview]Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes
NCT01680900 (6) [back to overview]Menopause-related Quality of Life (MENQOL)
NCT01680900 (6) [back to overview]Daily Diary Ratings of Severity of Hot Flashes
NCT01680900 (6) [back to overview]Daily Diary Ratings of Frequency of Hot Flashes
NCT01680900 (6) [back to overview]Number of Participants With Adverse Events
NCT01742832 (1) [back to overview]Montgomery-Åsberg Depression Rating Scale (MADRS)
NCT01828515 (1) [back to overview]Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at Day 19
NCT01844115 (2) [back to overview]Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
NCT01844115 (2) [back to overview]Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
NCT01878292 (2) [back to overview]Change in Clinical Global Impressions-Severity (CGI-S) Score
NCT01878292 (2) [back to overview]Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
NCT01999920 (6) [back to overview]Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire
NCT01999920 (6) [back to overview]Change From Baseline on Adult Separation Anxiety - 27 Scale
NCT01999920 (6) [back to overview]Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder
NCT01999920 (6) [back to overview]Clinical Global Impression-Improvement Scale
NCT01999920 (6) [back to overview]Change From Baseline in Attachment Style Questionnaire Score
NCT01999920 (6) [back to overview]Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score
NCT02015546 (9) [back to overview]Change in Clinical Global Impression-Improvement (CGI-I) Scale
NCT02015546 (9) [back to overview]Change in Clinical Global Impression-Severity (CGI-S) Scale
NCT02015546 (9) [back to overview]Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores
NCT02015546 (9) [back to overview]Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX)
NCT02015546 (9) [back to overview]Change in Sheehan Disability Scale (SDS)
NCT02015546 (9) [back to overview]Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS)
NCT02015546 (9) [back to overview]Change in Total MADRS Scores From Baseline to Week 8
NCT02015546 (9) [back to overview]MADRS Remission
NCT02015546 (9) [back to overview]MADRS Response
NCT02372799 (2) [back to overview]Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
NCT02372799 (2) [back to overview]Change in Clinical Global Impressions-Severity (CGI-S) Score
NCT02436239 (4) [back to overview]Change From Baseline in Clinical Global Impressions-Improvement (CGI-I)
NCT02436239 (4) [back to overview]Change From Baseline in the CDRS-R Total Score
NCT02436239 (4) [back to overview]Change From Baseline in the CGI-S Score
NCT02436239 (4) [back to overview]Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of study medication or was present at, or before, the day of the first dose of study medication and increased in severity during the treatment period. AEs included abnormal clinically significant findings for laboratory parameters, physical examinations, vital signs, weight, electrocardiograms (ECGs), the Change in Sexual Functioning Questionnaire (CSFQ), ophthalmologic exams and the Columbia-Suicide Severity Rating Scale (C-SSRS). (NCT00644358)
Timeframe: From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)

InterventionParticipants (Number)
Vilazodone562

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Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score

The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Participants were rated on 10 items 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 scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement. (NCT00644358)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 3Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 12Change from Baseline at Week 16Change from Baseline at Week 20Change from Baseline at Week 24Change from Baseline at Week 28Change from Baseline at Week 32Change from Baseline at Week 36Change from Baseline at Week 40Change from Baseline at Week 44Change from Baseline at Week 48Change from Baseline at Week 52Change from Baseline at Early Termination
Vilazodone29.9-4.7-9.3-13.0-14.9-17.1-18.5-19.9-20.6-21.1-21.7-21.6-21.9-22.1-22.7-21.9-22.5-22.8-10.9

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Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score

The CGI-S is a clinician-rated scale that measures global severity of illness at a given point in time using a 7-point scale where 1=normal, not at all ill, and 7=among the most severely ill. A negative change from Baseline indicates improvement. (NCT00644358)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 3Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 12Change from Baseline at Week 16Change from Baseline at Week 20Change from Baseline at Week 24Change from Baseline at Week 28Change from Baseline at Week 32Change from Baseline at Week 36Change from Baseline at Week 40Change from Baseline at Week 44Change from Baseline at Week 48Change from Baseline at Week 52Change from Baseline at Early Termination
Vilazodone4.3-0.3-0.7-1.1-1.4-1.7-1.9-2.1-2.3-2.4-2.4-2.4-2.5-2.5-2.5-2.4-2.5-2.6-1.0

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Clinical Global Impression - Improvement (CGI-I) Score

The CGI-I is a clinician-rated scale for assessing improvement of a patient's condition, using a 7-point scale where 1=very much improved (best) and 7=very much worse. (NCT00644358)
Timeframe: Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination

Interventionscore on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52Early Termination
Vilazodone3.53.02.52.32.01.91.71.61.51.51.51.51.51.41.51.41.42.9

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Change From Baseline to Week 8 in the HAM-A ( Hamilton Anxiety Rating Scale) Total Score

The HAM-A is a rating scale developed to quantify the severity of anxiety. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). Change from baseline in the HAM-A total score may range from -52 to 52 with negative value indicating improvement in anxiety symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely. (NCT00683592)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8

InterventionUnits on a scale (Least Squares Mean)
Vilazodone (ITT Population)-7.0
Placebo (ITT Population)-5.7

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Change From Baseline to Week 8 in the HAM-D 17 (17-Item Hamilton Rating Scale for Depression) Total Score

The HAM-D 17 is a 17-item subscale of the HAM-D 21, which is designed to be completed by a trained rater. It is designed for rating depressive symptom severity in patients with a confirmed diagnosis of depressive disorder. The change in HAM-D 17 has a possible range of -52 to 52 with negative values indicating improvment in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely. (NCT00683592)
Timeframe: Baseline, week 1, week 2, week 4, week 6, week 8

InterventionUnits on a scale (Least Squares Mean)
Vilazodone (ITT Population)-10.7
Placebo (ITT Population)-9.1

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Change From Baseline to Week 8 in the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score.

The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression. The scale was constructed to be sensitive to treatment effects. The change from baseline in MADRS total score has a possible range of -60 to 60 where negative values reflect improvement in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely. (NCT00683592)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8

InterventionUnits on a scale (Least Squares Mean)
Vilazodone (ITT Population)-13.3
Placebo (ITT Population)-10.8

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MADRS (Montgomery-Asberg Depression Rating Scale) Remission Rate at Week 8

MADRS remission was defined as a MADRS total score < 10 at Week 8. The remission rate is the percentage of subjects in each treatment group who met the criteria for remission. The method of last observation carried forward was utilized for subjects who discontinued prematurely. (NCT00683592)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8

InterventionParticipants (Number)
Vilazodone (ITT Population)63
Placebo (ITT Population)47

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MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate at Week 8

MADRS response was defined as ≥ 50% decrease from baseline in MADRS total score at Week 8. The response rate is the percentage of subjects in each treatment group meeting the criteria for response. The method of last observation carrier forward was utilized for subjects who discontinued prematurely. (NCT00683592)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8

InterventionParticipants (Number)
Vilazodone (ITT Population)101
Placebo (ITT Population)70

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The CGI-I (Clinician's Global Impression of Improvement) Score at Week 8

The CGI-I scale measures change from the baseline state at every visit after the baseline visit. It permits a global evaluation of the patient's improvement over time. At the scheduled clinic visits, the clinician assessed the patient's improvement relative to the symptoms at baseline on a CGI-I item using a 7-point scale, where 1 = very much improved and 7 = very much worse. The method of last observation carried forward was utilized for subjects who discontinued prematurely. (NCT00683592)
Timeframe: Week 1, Week 2, Week 4, Week 6, Week 8

InterventionUnits on a scale (Least Squares Mean)
Vilazodone (ITT Population)2.5
Placebo (ITT Population)2.8

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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

InterventionPercentage of participants (Number)
Placebo26.3
Vilazodone 20 mg/Day29.9
Vilazodone 40 mg/Day33.5
Citalopram 40 mg/Day31.1

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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

InterventionUnits 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

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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

InterventionUnits 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

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Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8

"The CGI-S is a clinician-rated scale for assessing the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. The clinician responded to the following question Considering your total clinical experience with this population, how mentally ill is the participant at this time? on a 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. The scale ranges from 1 to 7. A higher score indicates more severe mental illness. A negative change score indicates improvement." (NCT01473394)
Timeframe: Baseline to Week 8

InterventionUnits on a scale (Least Squares Mean)
Dose-matched Placebo-1.2
Vilazodone-1.8

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Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8

The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items 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 scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement. (NCT01473394)
Timeframe: Baseline to Week 8

InterventionUnits on a scale (Least Squares Mean)
Dose-matched Placebo-11.0
Vilazodone-16.1

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Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate

The MADRS Sustained response rate is defined as a MÅDRS total score ≤ 12 for at least the last 2 consecutive visits during the double-blind treatment period. (NCT01473394)
Timeframe: Baseline to Week 8

InterventionPercentage of participants (Number)
Dose-matched Placebo17.1
Vilazodone27.3

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Weekly Cannabis Use Sessions

Self-report of weekly cannabis use sessions was measured using the Time Line Followback, a calendar-based instrument designed to assess substance consumption. (NCT01574183)
Timeframe: 8 weeks

Interventionweekly cannabis sessions (Mean)
Vilazodone10
Placebo9.9

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Percent Marijuana-negative Urine Drug Screens (UDS)

Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group. (NCT01574183)
Timeframe: 8 weeks

Interventionpercentage of UDS (Number)
Vilazodone5.5
Placebo3.6

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Marijuana Craving and Withdrawal

The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) - 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly to all participants. Reported here is the mean MCQ purposefulness subscale score across 8 weeks. (NCT01574183)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Vilazodone8.9
Placebo11.3

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UKU Side-effect Profile

Number of participants with each side-effect event. (NCT01608295)
Timeframe: Each visit for 12 weeks

,
Interventionparticipants (Number)
Concentration DifficultiesSedationIncreased dream activityReduced salivationDiarrheaConstipationOrthostatic dizziness
Paroxetine; Paxil0331153
Vilazodone; Viibryd3133333

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Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)

Gene expression data were quantile-normalized and log2-transformed in RNA expression units. The measure included the promoter transcription factor binding motif prevalence ratio of the unit (log2 Vilazodone/Paroxetine) and ranging from a minimum of -3 to a maximum of 3 with higher scores indicating better outcomes. (NCT01608295)
Timeframe: Baseline and Final Visit

InterventionRNA expression units (Mean)
AP-1, Activator ProteinNF-kB, Nuclear Factor Kappa BGR, Glucocorticoid ReceptorCREB, cAMP response element binding protein
Vilazodone and Paroxetine-0.8-1.250.2-2.1

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Hamilton Depression Rating Scale (HDRS)

The HAMD measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. (NCT01608295)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
HDRS BaselineHDRS Final Visit
Paroxetine; Paxil16.67.5
Vilazodone; Viibryd17.27.6

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Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test

The The Rey-Osterrieth Complex Figure Test (REY-O) is a neuropsychological assessment in which measures visual perception and long-term visual memory. Total raw scores range from 0 to 36 with higher scores representing better outcomes in recall. The total raw score represents a sum of subscales scored by 18 individual elements which are scored for both distortion and placement. Two points are awarded to elements that are accurately drawn and properly placed, one point is given to distorted or misplaced elements, 0.5 points are given if an element is both distorted and misplaced, and missing or unrecognizable elements receive zero points. (NCT01608295)
Timeframe: Baseline and Final Visit

,
Interventionunits on a scale (Mean)
REY-O 3 Minute Delay BaselineREY-O 3 Minute Delay Final Visit
Paroxetine; Paxil13.316.3
Vilazodone; Viibryd13.315.2

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Change From Baseline in the Sheehan Disability Scale (SDS) Total Score

The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe). (NCT01629966)
Timeframe: Baseline to Week 8

InterventionScore on Scale (Mean)
Placebo8.4
Vilazadone 20mg7.7
Vilazodone 40mg6.7

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Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score

The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety. (NCT01629966)
Timeframe: Baseline to Week 8

InterventionScore on scale (Mean)
Placebo13.1
Vilazadone 20mg12.0
Vilazodone 40mg11.2

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Percentage of Participants That Were Satisfied or Very Satisfied

Patient global rating of satisfaction with medication reported on a scale of 0 to 5 (very satisfied). (NCT01680900)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Experimental 165
Placebo Capsules (Sugar Pill)75

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Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes

Percent of patients with n >=50% reduction in frequency of moderate to severe hot flashes calculated from daily diaries (NCT01680900)
Timeframe: Percent change from baseline at Week 8

Interventionpercentage of participants (Number)
Experimental 165
Placebo Capsules (Sugar Pill)83

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Daily Diary Ratings of Severity of Hot Flashes

Hot flash severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported. The severity of hot flashes was rated on a scale of 0 (none) to 3 (severe). 7-day averages were calculated for baseline, week 4 and week 8 and a mean daily score was obtained for analysis. Baseline values were the means of the first 2 screen weeks. Possible range of the severity scale for the daily mean was 0 (none) to 3 (severe). (NCT01680900)
Timeframe: Week 8.

Interventionunits on a scale (Mean)
Experimental 11.17
Placebo Capsules (Sugar Pill)1.39

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Daily Diary Ratings of Frequency of Hot Flashes

Hot flash frequency and severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported. (NCT01680900)
Timeframe: Week 8.

Interventionnumber of hot flashes (Mean)
Experimental 13.65
Placebo Capsules (Sugar Pill)4.71

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Number of Participants With Adverse Events

A 17 item checklist of general adverse and withdrawal symptoms. It will be used at baseline and Week 12. Adverse events will be obtained by subject report at Week 4 and Week 8. (NCT01680900)
Timeframe: Baseline and Week 12

Interventionparticipants (Number)
Experimental 117
Placebo Capsules (Sugar Pill)6

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Montgomery-Åsberg Depression Rating Scale (MADRS)

"The entire study will last 18 weeks. For the first 6 weeks, subjects will come in once every 2 weeks. For the next 4 weeks, subjects will come in once per week. For the next 6 weeks, subjects will come in once every 2 weeks. The final visit will come 2 weeks later for a total of 11 visits where the MADRS will be administered. Only the baseline and final (last observation) assessments for the outcome measure was used in determining results, thus these are the only values included.~MADRS scores range from 0-60, with higher scores indicating a greater level of severity. No subscales were used." (NCT01742832)
Timeframe: Baseline and final MADRS scores during the double-blind phase.

,
Interventionunits on a scale (Mean)
First Randomized Visit (Visit 8)Second Randomized Visit (Visit 9)Third Randomized Visit (Visit 10)Fourth Randomized Visit (Visit 11)
Citalopram12.713.213.512.7
Vilazodone13.914.513.913.9

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Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at Day 19

The Rey Auditory Verbal Learning Test (RAVLT) measures verbal or declarative learning and memory. The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. Equivalent, alternative versions (different words) were used to minimize practice or learning effects from repeated administration. The raw scores (number of words correct across trials 1-5) are converted to standardized T-scores (M=50; SD=10). This score is used to determine the participant's performance in relation to norm-referenced expectations based on age and sex. Higher score reflects better performance, and the values reflect scores at baseline minus the scores at Day 19. (NCT01828515)
Timeframe: Baseline and Day 19

InterventionT-score (Mean)
Vilazodone and Hydrocortisone-3
Placebo and Hydrocortisone0

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Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score

The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety. (NCT01844115)
Timeframe: Baseline to Week 8

InterventionScore on Scale (Mean)
Placebo14.7
Vilazodone11.3

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Change From Baseline in the Sheehan Disability Scale (SDS) Total Score

The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe). (NCT01844115)
Timeframe: Baseline to Week 8

InterventionScore on scale (Mean)
Placebo9.2
Vilazodone7.4

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Change in Clinical Global Impressions-Severity (CGI-S) Score

The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients. (NCT01878292)
Timeframe: From Baseline to Week 8

Interventionunits on a scale (Least Squares Mean)
Placebo-1.60
Vilazodone 15 mg-1.82
Vilazodone 30 mg-1.87

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Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score

The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. (NCT01878292)
Timeframe: From Baseline to week 8

Interventionunits on a scale (Least Squares Mean)
Placebo-22.48
Vilazodone 15 mg-22.94
Vilazodone 30 mg-24.22

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Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire

Measure Description: (10 min) Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q, Endicott et al, 1993): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80. (NCT01999920)
Timeframe: Up to 12 weeks

Interventionunits on a scale (Mean)
Vilazodone68.9
Placebo47.8

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Change From Baseline on Adult Separation Anxiety - 27 Scale

Measure Description: (15 min) Adult Separation Anxiety - 27 Scale 27 items pertaining to adult separation anxiety, each self-rated on a four-point scale, 0=best, 3=worse. Minimum Total Score=0 (better); Maximum Total Score = 81 (worse) (NCT01999920)
Timeframe: Up to 12 weeks

Interventionunits on a scale (Mean)
Vilazodone14.4
Placebo40.6

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Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder

The Structured Clinical Interview for Separation Anxiety Disorder was modified for DSM-5. The eight separation anxiety disorder criteria are rated for both childhood (rated at baseline only) and past week time frames, scored as 0 (not at all), 1 (sometimes), 2 (often) or ? (don't recall). In keeping with the DSM-5 guidelines, endorsement of three or more of the eight criterion symptoms (symptoms rated as '2' or 'often') is used as a threshold to determine categorical (yes/no) diagnosis of separation anxiety disorder. Scores on each of the eight items are also summed to produce a continuous measure of separation anxiety symptoms experienced during childhood and adulthood (range for each scale=0-16). (NCT01999920)
Timeframe: Baseline and week 12

Interventionunits on a scale (Mean)
Vilazodone3.1
Placebo5.0

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Clinical Global Impression-Improvement Scale

"Clinical Global Impression-Improvement Scale rating at week 12 A quickly administered and widely used observer rating, with ratings from 1 (very much improved) to 7 (very much worse). Responder is a score of 1 or 2." (NCT01999920)
Timeframe: Up to 12 weeks

InterventionParticipants (Count of Participants)
Vilazodone7
Placebo4

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Change From Baseline in Attachment Style Questionnaire Score

Measure Description: (15 min) Attachment Style Questionnaire (Feeney at al., 1994) 40 items relating to quality of adult relationships. Questionnaire includes questions concerning Confidence (8 items, minimum score=8, maximum score=48), Discomfort (10 items, minimum score=10, maximum score=60), Relationships as Secondary (7 items, minimum score=7, maximum score=42), Need for Approval (7 items, minimum score=7, maximum score =42), and Preoccupation with Relationships (8 items, minimum score = 8, maximum score=48), each self-rated on a six-point scale, each self-rated from 1 (totally disagree) to 6 (totally agree). (NCT01999920)
Timeframe: Up to 12 weeks

,
Interventionunits on a scale (Mean)
ConfidenceDiscomfort with ClosenessRelationships as SecondaryNeed for ApprovalPreoccupation with Relationships
Placebo26.942.320.723.632.1
Vilazodone32.335.616.320.630.0

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Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score

This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 12, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression). (NCT01999920)
Timeframe: Up to 12 weeks

Interventionunits on a scale (Mean)
Vilazodone3.7
Placebo8.4

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Change in Clinical Global Impression-Improvement (CGI-I) Scale

The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. (NCT02015546)
Timeframe: Baseline, Week 8

Interventionunits on a scale (Mean)
Vilazodone 10mg-1.647
Vilazodone 20mg-1.777
Vilazodone 40mg-1.529

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Change in Clinical Global Impression-Severity (CGI-S) Scale

"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening." (NCT02015546)
Timeframe: Baseline, 8 week

Interventionunits on a scale (Mean)
Vilazodone 10mg-2.176
Vilazodone 20mg-1.944
Vilazodone 40mg-2.058

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Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores

HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety. (NCT02015546)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Mean)
Vilazodone 10mg-3.937
Vilazodone 20mg-1.856
Vilazodone 40mg-1.013

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Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX)

"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction." (NCT02015546)
Timeframe: Baseline, Weeks 8

Interventionunits on a scale (Mean)
Vilazodone 10mg-3.640
Vilazodone 20mg-3.750
Vilazodone 40mg-3.741

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Change in Sheehan Disability Scale (SDS)

The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. (NCT02015546)
Timeframe: Baseline, 8 week

Interventionunits on a scale (Mean)
Vilazodone 10mg-3.72
Vilazodone 20mg-3.617
Vilazodone 40mg-3.364

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Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS)

"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The primary tolerability measure for discontinuation symptoms will be The Discontinuation Emergent Signs and Symptoms Check List (DESS). Discontinuation symptoms that do not respond to education and supportive psychotherapy will be managed by reinstituting the last dose of Vilazodone at which patients did not experience discontinuation symptoms and slowly tapering the dose over 1 week or longer, if necessary.~Total possible range is 0 to 172. A higher score indicates more symptoms." (NCT02015546)
Timeframe: Baseline, week 9

Interventionunits on a scale (Mean)
Vilazodone 10mg-3.597
Vilazodone 20mg-4.002
Vilazodone 40mg-4.120

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Change in Total MADRS Scores From Baseline to Week 8

The efficacy of switching to three different doses of vilazodone (10 mg/d, 20 mg/d, 40 mg/d) from equivalent dose range of generic SSRIs or SSNRIs in patients with MDD measured by the MADRS. The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms. (NCT02015546)
Timeframe: Baseline, Week 8

Interventionunits on a scale (Mean)
Vilazodone 10mg-24.95
Vilazodone 20mg-18.95
Vilazodone 40mg-23.89

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MADRS Remission

MADRS remission is defined as MADRS score < 10 (NCT02015546)
Timeframe: Week 8

Interventionparticipants (Number)
Vilazodone 10mg9
Vilazodone 20mg14
Vilazodone 40mg14

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MADRS Response

Number of subjects who had a ≥ 50% decrease in MADRS score from baseline (NCT02015546)
Timeframe: Baseline, Week 8

Interventionparticipants (Number)
Vilazodone 10mg14
Vilazodone 20mg15
Vilazodone 40mg15

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Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score

The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. (NCT02372799)
Timeframe: From Baseline to Week 8

Interventionunits on a scale (Least Squares Mean)
Placebo-20.32
Vilazodone-20.72
Fluoxetine-22.71

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Change in Clinical Global Impressions-Severity (CGI-S) Score

The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients. (NCT02372799)
Timeframe: From Baseline to Week 8

Interventionunits on a scale (Least Squares Mean)
Placebo-1.52
Vilazodone-1.57
Fluoxetine-1.72

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Change From Baseline in Clinical Global Impressions-Improvement (CGI-I)

The Clinical Global Impressions-Improvement is a clinician-rated instrument that was used to rate total improvement or worsening of mental illness, regardless of whether the Investigator considered it to be a result of treatment with the investigational product. The CGI-I was used to rate the patient's improvement on a scale from 1 to 7, with 1 indicating that the patient was very much improved (with a score of 4 indicating no change) and 7 indicating the patient was very much worse. (NCT02436239)
Timeframe: Baseline (Week 0) to Week 26

Interventionunits on a scale (Mean)
Placebo/Vilazodone2.1
Vilazodone/Vilazodone2.0
Fluoxetine/Vilazodone2.0
De Novo/Vilazodone2.2

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Change From Baseline in the CDRS-R Total Score

The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. (NCT02436239)
Timeframe: Baseline (Week 0) to Week 26

Interventionunits on a scale (Mean)
Placebo/Vilazodone-29.2
Vilazodone/Vilazodone-30.1
Fluoxetine/Vilazodone-29.4
De Novo/Vilazodone-24.5

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Change From Baseline in the CGI-S Score

The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients. (NCT02436239)
Timeframe: Baseline (Week 0) to Week 26

Interventionunits on a scale (Mean)
Placebo/Vilazodone-2.5
Vilazodone/Vilazodone-2.6
Fluoxetine/Vilazodone-2.5
De Novo/Vilazodone-1.7

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Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)

The number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period (NCT02436239)
Timeframe: Visit 1 (Week -1) to up to Visit 16 (Week 26)

InterventionParticipants (Count of Participants)
Placebo/Vilazodone90
Vilazodone/Vilazodone89
Fluoxetine/Vilazodone48
De Novo/Vilazodone10

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