Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder (VLZ-MD-05)

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Generalized Anxiety Disorder

Treatments: Drug: Vilazodone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01629966

VLZ-MD-05

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: 680 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

• History of meeting DSM-IV-TR criteria for any of the following:

  • Any manic or 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 significant cognitive disorders

• Patients who are considered a suicide risk

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

680 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Dose-matched placebo one per day, oral administration

Treatment:

Drug: Placebo

Vilazadone 20mg

Experimental group

Description:

Vilazodone 20mg once per day, oral administration.

Treatment:

Drug: Vilazodone

Drug: Vilazodone

Vilazodone 40mg

Experimental group

Description:

Vilazodone 40mg once per day, oral administration

Treatment:

Drug: Vilazodone

Drug: Vilazodone