Trial · NCT01844115

Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder

NCT01844115, 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 (GAD) Generalized Anxiety Disorder. Trials, record NCT01844115. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01844115

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Trial

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

Title: Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder
NCT number: NCT01844115
Status: Completed
Phases: Phase 3
Enrollment: 415 participants, actual
Lead sponsor: Forest Laboratories
Conditions: Generalized Anxiety Disorder
Interventions: Placebo, Vilazodone
First posted: 2013-05-01
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 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 From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	Placebo	14.7	Standard Deviation 7.41	Score on Scale
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	Vilazodone	11.3	Standard Deviation 6.99	Score on Scale
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score	Placebo	9.2	Standard Deviation 6.96	Score on scale
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score	Vilazodone	7.4	Standard Deviation 6.96	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	202
Overall Study	STARTED	Vilazodone	202
Overall Study	COMPLETED	Placebo	163
Overall Study	COMPLETED	Vilazodone	144
Overall Study	NOT COMPLETED	Placebo	39
Overall Study	NOT COMPLETED	Vilazodone	58

Source ClinicalTrials.gov

Adverse events28

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	26	202
other	Nausea	Gastrointestinal disorders	Vilazodone	60	202
other	Diarrhoea	Gastrointestinal disorders	Placebo	12	202
other	Diarrhoea	Gastrointestinal disorders	Vilazodone	56	202
other	Dry mouth	Gastrointestinal disorders	Placebo	12	202
other	Dry mouth	Gastrointestinal disorders	Vilazodone	12	202
other	Upper respiratory tract infection	Infections and infestations	Placebo	11	202
other	Upper respiratory tract infection	Infections and infestations	Vilazodone	5	202
other	Dizziness	Nervous system disorders	Placebo	8	202
other	Dizziness	Nervous system disorders	Vilazodone	22	202

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	202
Total, all-cause mortality	Vilazodone	0	202
Total, other adverse events	Placebo	81	202
Total, other adverse events	Vilazodone	115	202
Total, serious adverse events	Placebo	0	202
Total, serious adverse events	Vilazodone	3	202

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27232052	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
Vilazodone vs Placebo: deaths from any cause	Trial comparisons
Vilazodone 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/NCT01844115

GET https://conductscience.org/api/trials/v1/NCT01844115/events?page=2

API reference For AI assistants