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

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Generalized Anxiety Disorder

Treatments: Drug: Placebo; Drug: Vilazodone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01844115

VLZ-MD-07

Details and patient eligibility

About

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).

Enrollment: 415 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female outpatient, 18-70 years of age
• Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder
• Minimum score of 20 on Hamilton Rating Scale for Anxiety

Exclusion criteria

• Women who are pregnant or who will be breastfeeding during the study

• Patients with a history of:

  1. Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode
  2. Any depressive episode with psychotic or catatonic features
  3. Panic disorder with or without agoraphobia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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415 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Dose-matched placebo tablets, oral administration

Treatment:

Drug: Placebo

Vilazodone

Experimental group

Description:

Vilazodone tablets, oral administration

Treatment:

Drug: Vilazodone