Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

Major Depressive Disorder Clinical Trial

Official title:

A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715805
• Other study ID #: RGH-MD-72
• Status: Completed
• Phase: Phase 3
• Start date: November 15, 2012
• Est. completion date: June 24, 2016

Study information

• Verified date: August 2019
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1022
• Est. completion date: June 24, 2016
• Est. primary completion date: June 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients who have provided consent prior to any specific procedure

• Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)

• Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2

Exclusion Criteria:

• Patients who do not meet DSM-IV-TR criteria for MDD

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cariprazine
Cariprazine capsules 1.5 to 4.5 mg/day
• Placebo
Dose-matched placebo capsule once per day
• Antidepressant Therapy (ADT)
ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.

Locations

Country	Name	City	State
Puerto Rico	Forest Investigative Site 033	San Juan
Puerto Rico	Forest Investigative Site 034	San Juan
United States	Forest Investigative Site 058	Albuquerque	New Mexico
United States	Forest Investigative Site 052	Allentown	Pennsylvania
United States	Forest Investigative Site 024	Atlanta	Georgia
United States	Forest Investigative Site 060	Atlanta	Georgia
United States	Forest Investigative Site 079	Austin	Texas
United States	Forest Investigative Site 081	Bellevue	Washington
United States	Forest Investigative Site 067	Bismarck	North Dakota
United States	Forest Investigative Site 046	Boston	Massachusetts
United States	Forest Investigative Site 076	Bronx	New York
United States	Forest Investigative Site 028	Brooklyn	New York
United States	Forest Investigative Site 088	Canton	Ohio
United States	Forest Investigative Site 084	Cerritos	California
United States	Forest Investigative Site 001	Charleston	South Carolina
United States	Forest Investigative Site 041	Charlottesville	Virginia
United States	Forest Investigative Site 070	Chicago	Illinois
United States	Forest Investigative Site 011	Cincinnati	Ohio
United States	Forest Investigative Site 015	Cincinnati	Ohio
United States	Forest Investigative Site 089	Cincinnati	Ohio
United States	Forest Investigative Site 055	Columbus	Ohio
United States	Forest Investigative Site 037	Coral Springs	Florida
United States	Forest Investigative Site 085	Culver City	California
United States	Forest Investigative Site 048	Denver	Colorado
United States	Forest Investigative Site 050	Durham	North Carolina
United States	Forest Investigative Site 053	Fort Myers	Florida
United States	Forest Investigative Site 049	Gaithersburg	Maryland
United States	Forest Investigative Site 082	Garden Grove	California
United States	Forest Investigative Site 023	Hallandale Beach	Florida
United States	Forest Investigative Site 071	Hialeah	Florida
United States	Forest Investigative Site 013	Hoffman Estates	Illinois
United States	Forest Investigative Site 005	Houston	Texas
United States	Forest Investigative Site 061	Indianapolis	Indiana
United States	Forest Investigative Site 042	Lafayette	Indiana
United States	Forest Investigative Site 006	Leesburg	Florida
United States	Forest Investigative Site 063	Libertyville	Illinois
United States	Forest Investigative Site 059	Lincoln	Rhode Island
United States	Forest Investigative Site 018	Little Rock	Arkansas
United States	Forest Investigative Site 029	Little Rock	Arkansas
United States	Forest Investigative Site 017	Marietta	Georgia
United States	Forest Investigative Site 066	Mason	Ohio
United States	Forest Investigative Site 062	Maywood	Illinois
United States	Forest Investigative Site 026	Miami	Florida
United States	Forest Investigative Site 075	Miami	Florida
United States	Forest Investigative Site 064	Middleburg Heights	Ohio
United States	Forest Investigative Site 056	Milwaukee	Wisconsin
United States	Forest Investigative Site 072	Naperville	Illinois
United States	Forest Investigative Site 045	Natick	Massachusetts
United States	Forest Investigative Site 073	New Orleans	Louisiana
United States	Forest Investigative Site 016	New York	New York
United States	Forest Investigative Site 083	New York	New York
United States	Forest Investigative Site 022	Newport Beach	California
United States	Forest Investigative Site 027	North Miami	Florida
United States	Forest Investigative Site 074	North Miami	Florida
United States	Forest Investigative Site 010	Oak Brook	Illinois
United States	Forest Investigative Site 036	Oakland Park	Florida
United States	Forest Investigative Site 004	Oceanside	California
United States	Forest Investigative Site 035	Oklahoma City	Oklahoma
United States	Forest Investigative Site 038	Oklahoma City	Oklahoma
United States	Forest Investigative Site 039	Oklahoma City	Oklahoma
United States	Forest Investigative Site 030	Orem	Utah
United States	Forest Investigative Site 051	Orlando	Florida
United States	Forest Investigative Site 065	Overland Park	Kansas
United States	Forest Investigative Site 003	Portland	Oregon
United States	Forest Investigative Site 090	Rancho Mirage	California
United States	Forest Investigative Site 078	Redlands	California
United States	Forest Investigative Site 080	Redlands	California
United States	Forest Investigative Site 012	Rockville	Maryland
United States	Forest Investigative Site 077	Rockville	Maryland
United States	Forest Investigative Site 086	Saint Charles	Missouri
United States	Forest Investigative Site 007	San Diego	California
United States	Forest Investigative Site 054	San Diego	California
United States	Forest Investigative Site 043	Seattle	Washington
United States	Forest Investigative Site 068	Skokie	Illinois
United States	Forest Investigative Site 047	Smyrna	Georgia
United States	Forest Investigative Site 044	South Miami	Florida
United States	Forest Investigative Site 025	Staten Island	New York
United States	Forest Investigative Site 008	Tampa	Florida
United States	Forest Investigative Site 031	Temecula	California
United States	Forest Investigative Site 087	The Woodlands	Texas
United States	Forest Investigative Site 014	Toms River	New Jersey
United States	Forest Investigative Site 032	Tucson	Arizona
United States	Forest Investigative Site 057	Waukesha	Wisconsin
United States	Forest Investigative Site 069	Wichita Falls	Texas
United States	Forest Investigative Site 019	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Gedeon Richter Ltd.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period	The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60.	Baseline (Week 8)
Primary	Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period	The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60. A negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.	Baseline (Week 8) to Week 16
Secondary	Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period	The Sheehan Disability Scale (SDS) is a 3-item patient-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum from 0 (no impairment) to 10 (most severe). The 3 individual scores are summed for a total possible score of 0 (unimpaired) to 30 (highly impaired). A negative change from Baseline indicates improvement. MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.	Baseline (Week 8) to Week 16

External Links

•   Link to detailed contact information on study locations