Safety and Efficacy of Vilazodone in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study With Vilazodone in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01573598
• Other study ID #: VLZ-MD-02
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2012
• Last updated: May 15, 2015
• Start date: April 2012
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety and Efficacy of Vilazodone in Major Depressive Disorder

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1219
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Placebo
Matching placebo given orally, once per day
• Vilazodone
Vilazodone, 20 mg per day, oral administration
• Vilazodone
Vilazodone, 40 mg once per day, oral administration

Locations

Country	Name	City	State
Bulgaria	Forest Investigative Site 103	Pleven
Bulgaria	Forest Investigative Site 104	Plovdiv
Bulgaria	Forest Investigative Site 102	Sofia
Bulgaria	Forest Investigative Site 106	Sofia
Finland	Forest Investigative Site 301	Helsinki	Etelä-Suomen lääni
Finland	Forest Investigative Site 304	Helsinki	Etelä-Suomen lääni
Finland	Forest Investigative Site 305	Helsinki	Etelä-Suomen lääni
Finland	Forest Investigative Site 302	Kuopio
Finland	Forest Investigative Site 303	Rauma	Länsi-Suomen lääni
Finland	Forest Investigative Site 306	Turku
Finland	Forest Investigative Site 307	Turku
Germany	Forest Investigative Site 403	Berlin
Germany	Forest Investigative Site 408	Berlin
Germany	Forest Investigative Site 407	Chemnitz
Germany	Forest Investigative Site 405	Dresden	Sachsen
Germany	Forest Investigative Site 401	Hannover	Niedersachsen
Germany	Forest Investigative Site 402	Hüttenberg
Germany	Forest Investigative Site 409	Münster
Germany	Forest Investigative Site 404	Nürnberg
Germany	Forest Investigative Site 406	Westerstede
Romania	Forest Investigative Site 601	Arad
Romania	Forest Investigative Site 602	Bucuresti	Bucuresti
Romania	Forest Investigative Site 603	Iasi
Russian Federation	Forest Investigative Site 701	Moscow
Russian Federation	Forest Investigative Site 705	Petrozavodsk	Kareliya, Respublika
Serbia	Forest Investigative Site 804	Belgrade	Beograd
Serbia	Forest Investigative Site 801	Beograd
Serbia	Forest Investigative Site 802	Beograd
Serbia	Forest Investigative Site 803	Kragujevac
Serbia	Forest Investigative Site 805	Kragujevac	Šumadija
Serbia	Forest Investigative Site 806	Nis	Nišava
Ukraine	Forest Investigative Site 902	Dnipropetrovsk
Ukraine	Forest Investigative Site 903	Kherson	Khersons'ka Oblast'
Ukraine	Forest Investigative Site 905	Lugansk	Luhans'ka Oblast'
Ukraine	Forest Investigative Site 901	Lviv	L'vivs'ka Oblast'
Ukraine	Forest Investigative Site 906	Odesa	Odes'ka Oblast'
Ukraine	Forest Investigative Site 904	Simferopol
United States	Forest Investigative Site 033	Bellevue	Washington
United States	Forest Investigative Site 030	Beverly Hills	California
United States	Forest Investigative Site 003	Boston	Massachusetts
United States	Forest Investigative Site 038	Brooklyn	New York
United States	Forest Investigative Site 012	Chino	California
United States	Forest Investigative Site 022	Costa Mesa	California
United States	Forest Investigative Site 016	Cromwell	Connecticut
United States	Forest Investigative Site 023	Dallas	Texas
United States	Forest Investigative Site 020	Doral	Florida
United States	Forest Investigative Site 014	Durham	North Carolina
United States	Forest Investigative Site 006	Fort Myers	Florida
United States	Forest Investigative Site 007	Ft. Lauderdale	Florida
United States	Forest Investigative Site 004	Hallandale Beach	Florida
United States	Forest Investigative Site 029	Hartford	Connecticut
United States	Forest Investigative Site 019	Hoffman Estates	Illinois
United States	Forest Investigative Site 011	Houston	Texas
United States	Forest Investigative Site 021	Indianapolis	Indiana
United States	Forest Investigative Site 039	Jacksonville	Florida
United States	Forest Investigative Site 008	Jacksonville Beach	Florida
United States	Forest Investigative Site 015	Leesburg	Florida
United States	Forest Investigative Site 017	Los Angeles	California
United States	Forest Investigative Site 036	Memphis	Tennessee
United States	Forest Investigative Site 009	New York	New York
United States	Forest Investigative Site 032	New York	New York
United States	Forest Investigative Site 037	New York	New York
United States	Forest Investigative Site 005	Newport Beach	California
United States	Forest Investigative Site 024	Oklahoma City	Oklahoma
United States	Forest Investigative Site 025	Oklahoma City	Oklahoma
United States	Forest Investigative Site 035	Orlando	Florida
United States	Forest Investigative Site 010	Plano	Texas
United States	Forest Investigative Site 031	Richmond	Virginia
United States	Forest Investigative Site 027	Riverside	California
United States	Forest Investigative Site 028	Rochester Hills	Michigan
United States	Forest Investigative Site 002	San Antonio	Texas
United States	Forest Investigative Site 026	San Diego	California
United States	Forest Investigative Site 001	West Palm Beach	Florida
United States	Forest Investigative Site 013	Weymouth	Massachusetts
United States	Forest Investigative Site 034	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Bulgaria,  Finland,  Germany,  Romania,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first relapse during the double-blind treatment phase		Number of days from the randomization date to the relapse date, up to 28 weeks.