Safety and Efficacy of Vilazodone in Major Depressive Disorder

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Vilazodone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01573598

VLZ-MD-02

Details and patient eligibility

About

Safety and Efficacy of Vilazodone in Major Depressive Disorder

Enrollment: 1,219 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women, 18-70 years of age
• Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
• The patient's current major depressive episode must be at least 8 weeks and no longer than 18 months in duration

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; h. 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

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1,219 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Dose-matched placebo capsules, oral administration

Treatment:

Drug: Placebo

Vilazodone 20mg

Experimental group

Description:

Vilazodone tablets, 20 mg per day, oral administration

Treatment:

Drug: Vilazodone

Drug: Vilazodone

Vilazodone 40mg

Experimental group

Description:

Vilazodone tablets, 40 mg per day, oral administration

Treatment:

Drug: Vilazodone

Drug: Vilazodone