Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder (VLZ-MD-06)

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Forest Laboratories

Status and phase

Completed
Phase 3

Conditions

Generalized Anxiety Disorder

Treatments

Drug: Placebo
Drug: Vilazadone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01766401
VLZ-MD-06

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

402 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male and female, 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 (GAD)
  • Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)

Exclusion criteria

  • Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control

  • Patients with a history of meeting DSM-IV-TR criteria for:

    • any manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode;
    • any depressive episode with psychotic or catatonic features;
    • panic disorder with or without agoraphobia;
    • obsessive-compulsive disorder;
    • Schizophrenia, schizoaffective, or other psychotic disorder;
    • bulimia or anorexia nervosa;
    • presence of borderline personality disorder or antisocial personality disorder;
    • mental retardation, dementia, amnesia, or other cognitive disorders
  • Patients who are considered a suicide risk

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

402 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Matching placebo tablets, oral administration
Treatment:
Drug: Placebo
Vilazadone
Experimental group
Description:
Vilazadone tablets, oral administration
Treatment:
Drug: Vilazadone

Trial contacts and locations

30

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Data sourced from clinicaltrials.gov

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