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NCT01766401 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Forest Laboratories.

Completed
Registry status
Phase 3
Development phase
402
Enrollment target

NCT01766401: Completed Phase 3 study, sponsored by Forest Laboratories.

NCT01766401 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 402 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01766401, a Phase 3 study, has completed, sponsored by Forest Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
402 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD).

Primary Outcome

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.

Interventions

  • DRUG Placebo
  • DRUG Vilazadone

Trial Details

FieldValue
Enrollment Target 402 participants
Start Date 2013-01-31
Est. Completion 2014-01-29
Phase Phase 3
Forest Laboratories

145 total trials

What the finished NCT01766401 record still lists

NCT01766401 is an interventional study that assigns participants to a tested intervention. The registered 402 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01766401 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01766401 about?

NCT01766401 is a clinical study titled "Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder". The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD).

What is the current status of trial NCT01766401?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 402 participants. The study started on 2013-01-31. Estimated completion is 2014-01-29.

What interventions are being tested in trial NCT01766401?

The interventions under investigation include: Placebo (DRUG), Vilazadone (DRUG).

Who is sponsoring clinical trial NCT01766401?

This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01766401's enrollment target sits among peer trials

402 919th of 2000 higher than 1,080 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01766401, the US trial registry maintained by the National Library of Medicine. NCT01766401 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.