Trial · NCT01473381

Safety and Efficacy of Vilazodone in Major Depressive Disorder

NCT01473381, Phase 4, Completed, Forest Laboratories; results first posted 2014-08-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Vilazodone in Major Depressive Disorder. Trials, record NCT01473381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01473381

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Vilazodone in Major Depressive Disorder
NCT number: NCT01473381
Status: Completed
Phases: Phase 4
Enrollment: 1,162 participants, actual
Lead sponsor: Forest Laboratories
Conditions: Major Depressive Disorder
Interventions: Vilazodone, Placebo to citalopram, Placebo to vilazodone, Citalopram
First posted: 2011-11-17
Last updated: 2014-08-08
Results first posted: 2014-08-08

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10	Baseline to 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.
Secondary	Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score	Baseline to Week 10	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.
Secondary	Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response	Baseline to 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 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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10	Baseline to Week 10	Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score	Baseline to Week 10	Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response	Baseline to Week 10	Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10	Placebo	-14.76	Standard Error 0.62	Units on a scale
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10	Vilazodone 20 mg/Day	-17.33	Standard Error 0.63	Units on a scale
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10	Vilazodone 40 mg/Day	-17.58	Standard Error 0.65	Units on a scale
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10	Citalopram 40 mg/Day	-17.50	Standard Error 0.64	Units on a scale
Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score	Placebo	-1.53	Standard Error 0.08	Units on a scale
Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score	Vilazodone 20 mg/Day	-1.88	Standard Error 0.08	Units on a scale
Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score	Vilazodone 40 mg/Day	-1.86	Standard Error 0.08	Units on a scale
Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score	Citalopram 40 mg/Day	-1.88	Standard Error 0.08	Units on a scale
Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response	Placebo	26.3	95% Confidence Interval 21.2 to 31.5	Percentage of participants
Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response	Vilazodone 20 mg/Day	29.9	95% Confidence Interval 24.6 to 35.1	Percentage of participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	290
Overall Study	STARTED	Vilazodone 20 mg/Day	292
Overall Study	STARTED	Vilazodone 40 mg/Day	291
Overall Study	STARTED	Citalopram 40 mg/Day	289
Overall Study	Safety Population	Placebo	281
Overall Study	Safety Population	Vilazodone 20 mg/Day	288
Overall Study	Safety Population	Vilazodone 40 mg/Day	287
Overall Study	Safety Population	Citalopram 40 mg/Day	282
Overall Study	COMPLETED	Placebo	210
Overall Study	COMPLETED	Vilazodone 20 mg/Day	199

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events164

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Placebo	26	281
other	Diarrhoea	Gastrointestinal disorders	Vilazodone 20 mg/Day	75	288
other	Diarrhoea	Gastrointestinal disorders	Vilazodone 40 mg/Day	76	287
other	Diarrhoea	Gastrointestinal disorders	Citalopram 40 mg/Day	30	282
other	Nausea	Gastrointestinal disorders	Placebo	23	281
other	Nausea	Gastrointestinal disorders	Vilazodone 20 mg/Day	62	288
other	Nausea	Gastrointestinal disorders	Vilazodone 40 mg/Day	69	287
other	Nausea	Gastrointestinal disorders	Citalopram 40 mg/Day	55	282
other	Headache	Nervous system disorders	Placebo	39	281
other	Headache	Nervous system disorders	Vilazodone 20 mg/Day	42	288

1 to 10 of 164Source ClinicalTrials.gov

See all 164 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Vilazodone 20 mg/Day
Total, all-cause mortality	Vilazodone 40 mg/Day
Total, all-cause mortality	Citalopram 40 mg/Day
Total, other adverse events	Placebo	124	281
Total, other adverse events	Vilazodone 20 mg/Day	168	288
Total, other adverse events	Vilazodone 40 mg/Day	177	287
Total, other adverse events	Citalopram 40 mg/Day	147	282
Total, serious adverse events	Placebo	3	281
Total, serious adverse events	Vilazodone 20 mg/Day	4	288

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25500685	DERIVED	PubMed
26039688	DERIVED	PubMed
26693034	DERIVED	PubMed
29608461	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01473381

GET https://conductscience.org/api/trials/v1/NCT01473381/events?page=2

API reference For AI assistants