Trial · NCT01766401

Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder

NCT01766401, 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 Patients With Generalized Anxiety Disorder. Trials, record NCT01766401. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01766401

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 Patients With Generalized Anxiety Disorder
NCT number: NCT01766401
Status: Completed
Phases: Phase 3
Enrollment: 402 participants, actual
Lead sponsor: Forest Laboratories
Conditions: Generalized Anxiety Disorder
Interventions: Placebo, Vilazadone
First posted: 2013-01-11
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 in 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 in 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 the 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 the HAM-A.	Score on Scale	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Change in Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	Placebo	14.9	Standard Deviation 7.37	Score on Scale
Change in Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	Vilazadone	13.5	Standard Deviation 7.41	Score on Scale
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score	Placebo	10.1	Standard Deviation 6.58	Score on Scale
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score	Vilazadone	7.8	Standard Deviation 6.91	Score on Scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	198
Overall Study	STARTED	Vilazadone	200
Overall Study	COMPLETED	Placebo	161
Overall Study	COMPLETED	Vilazadone	144
Overall Study	NOT COMPLETED	Placebo	37
Overall Study	NOT COMPLETED	Vilazadone	56

Source ClinicalTrials.gov

Adverse events18

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	19	198
other	Nausea	Gastrointestinal disorders	Vilazadone	63	200
other	Diarrhoea	Gastrointestinal disorders	Placebo	24	198
other	Diarrhoea	Gastrointestinal disorders	Vilazadone	62	200
other	Vomiting	Gastrointestinal disorders	Placebo	2	198
other	Vomiting	Gastrointestinal disorders	Vilazadone	13	198
other	Dry mouth	Gastrointestinal disorders	Placebo	10	198
other	Dry mouth	Gastrointestinal disorders	Vilazadone	11	200
other	Upper respiratory tract infection	Infections and infestations	Placebo	10	198
other	Upper respiratory tract infection	Infections and infestations	Vilazadone	9	200

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	198
Total, all-cause mortality	Vilazadone	0	200
Total, other adverse events	Placebo	75	198
Total, other adverse events	Vilazadone	130	200
Total, serious adverse events	Placebo	0	198
Total, serious adverse events	Vilazadone	0	200

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26291335	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 comparisons2

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

Comparison	Source
Vilazadone vs Placebo: deaths from any cause	Trial comparisons
Vilazadone vs Placebo: serious adverse events	Trial comparisons

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/NCT01766401

GET https://conductscience.org/api/trials/v1/NCT01766401/registered

API reference For AI assistants