Trial · NCT01629966

Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder

NCT01629966, Phase 3, Completed, Forest Laboratories; results first posted 2019-12-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder. Trials, record NCT01629966. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01629966

On this page

Trial

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

Title: Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder
NCT number: NCT01629966
Status: Completed
Phases: Phase 3
Enrollment: 680 participants, actual
Lead sponsor: Forest Laboratories
Conditions: Generalized Anxiety Disorder
Interventions: Placebo, Vilazodone, Vilazodone
First posted: 2012-06-28
Last updated: 2019-12-18
Results first posted: 2019-12-18

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	Baseline to Week 8	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.
Secondary	Change From Baseline in the Sheehan Disability Scale (SDS) Total Score	Baseline to Week 8	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).

Source ClinicalTrials.gov

Outcomes2

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 Hamilton Rating Scale for Anxiety (HAM-A) Total Score	Baseline to Week 8	The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of HAM-A.	Score on scale	MEAN
SECONDARY	Change From Baseline in the Sheehan Disability Scale (SDS) Total Score	Baseline to Week 8	The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of HAM-A.	Score on Scale	MEAN

Source ClinicalTrials.gov

Results by group6

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 Hamilton Rating Scale for Anxiety (HAM-A) Total Score	Placebo	13.1	Standard Deviation 7.93	Score on scale
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	Vilazadone 20mg	12.0	Standard Deviation 7.13	Score on scale
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	Vilazodone 40mg	11.2	Standard Deviation 7.46	Score on scale
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score	Placebo	8.4	Standard Deviation 7.53	Score on Scale
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score	Vilazadone 20mg	7.7	Standard Deviation 6.51	Score on Scale
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score	Vilazodone 40mg	6.7	Standard Deviation 6.62	Score on Scale

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	221
Overall Study	STARTED	Vilazadone 20mg	227
Overall Study	STARTED	Vilazodone 40mg	225
Overall Study	COMPLETED	Placebo	180
Overall Study	COMPLETED	Vilazadone 20mg	175
Overall Study	COMPLETED	Vilazodone 40mg	159
Overall Study	NOT COMPLETED	Placebo	41
Overall Study	NOT COMPLETED	Vilazadone 20mg	52
Overall Study	NOT COMPLETED	Vilazodone 40mg	66

Source ClinicalTrials.gov

Adverse events33

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	Nausea	Gastrointestinal disorders	Placebo	25	221
other	Nausea	Gastrointestinal disorders	Vilazadone 20mg	55	227
other	Nausea	Gastrointestinal disorders	Vilazodone 40mg	58	225
other	Diarrhoea	Gastrointestinal disorders	Placebo	23	221
other	Diarrhoea	Gastrointestinal disorders	Vilazadone 20mg	57	227
other	Diarrhoea	Gastrointestinal disorders	Vilazodone 40mg	48	225
other	Vomiting	Gastrointestinal disorders	Placebo	5	221
other	Vomiting	Gastrointestinal disorders	Vilazadone 20mg	13	227
other	Vomiting	Gastrointestinal disorders	Vilazodone 40mg	17	225
other	Dry mouth	Gastrointestinal disorders	Placebo	12	221

1 to 10 of 33Source ClinicalTrials.gov

See all 33 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	221
Total, all-cause mortality	Vilazadone 20mg	0	227
Total, all-cause mortality	Vilazodone 40mg	0	225
Total, other adverse events	Placebo	85	221
Total, other adverse events	Vilazadone 20mg	123	227
Total, other adverse events	Vilazodone 40mg	121	225
Total, serious adverse events	Placebo	1	221
Total, serious adverse events	Vilazadone 20mg	1	227
Total, serious adverse events	Vilazodone 40mg	0	225

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25891440	DERIVED	PubMed
27486544	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/NCT01629966

GET https://conductscience.org/api/trials/v1/NCT01629966/events?page=2

API reference For AI assistants