Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT01715805
- Lead Sponsor
- Forest Laboratories
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1022
- 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
- Patients who do not meet DSM-IV-TR criteria for MDD
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + ADT (Double-Blind) Placebo Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16). Placebo + ADT Lead-in Antidepressant Therapy (ADT) Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks. Placebo + ADT Lead-in Placebo Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks. Placebo + ADT (Double-Blind) Antidepressant Therapy (ADT) Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16). Cariprazine + ADT (Double-Blind) Antidepressant Therapy (ADT) Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16). Placebo + ADT (Continued Treatment) Placebo Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks. Placebo + ADT (Continued Treatment) Antidepressant Therapy (ADT) Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks. Cariprazine + ADT (Double-Blind) Cariprazine Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).
- Primary Outcome Measures
Name Time Method Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period Baseline (Week 8) 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.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period Baseline (Week 8) to Week 16 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period Baseline (Week 8) to Week 16 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.
Trial Locations
- Locations (85)
Forest Investigative Site 067
🇺🇸Bismarck, North Dakota, United States
Forest Investigative Site 018
🇺🇸Little Rock, Arkansas, United States
Forest Investigative Site 080
🇺🇸Redlands, California, United States
Forest Investigative Site 013
🇺🇸Hoffman Estates, Illinois, United States
Forest Investigative Site 032
🇺🇸Tucson, Arizona, United States
Forest Investigative Site 029
🇺🇸Little Rock, Arkansas, United States
Forest Investigative Site 077
🇺🇸Rockville, Maryland, United States
Forest Investigative Site 006
🇺🇸Leesburg, Florida, United States
Forest Investigative Site 017
🇺🇸Marietta, Georgia, United States
Forest Investigative Site 065
🇺🇸Overland Park, Kansas, United States
Forest Investigative Site 078
🇺🇸Redlands, California, United States
Forest Investigative Site 023
🇺🇸Hallandale Beach, Florida, United States
Forest Investigative Site 053
🇺🇸Fort Myers, Florida, United States
Forest Investigative Site 031
🇺🇸Temecula, California, United States
Forest Investigative Site 074
🇺🇸North Miami, Florida, United States
Forest Investigative Site 071
🇺🇸Hialeah, Florida, United States
Forest Investigative Site 024
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 062
🇺🇸Maywood, Illinois, United States
Forest Investigative Site 068
🇺🇸Skokie, Illinois, United States
Forest Investigative Site 070
🇺🇸Chicago, Illinois, United States
Forest Investigative Site 036
🇺🇸Oakland Park, Florida, United States
Forest Investigative Site 027
🇺🇸North Miami, Florida, United States
Forest Investigative Site 033
🇵🇷San Juan, Puerto Rico
Forest Investigative Site 028
🇺🇸Brooklyn, New York, United States
Forest Investigative Site 045
🇺🇸Natick, Massachusetts, United States
Forest Investigative Site 059
🇺🇸Lincoln, Rhode Island, United States
Forest Investigative Site 052
🇺🇸Allentown, Pennsylvania, United States
Forest Investigative Site 083
🇺🇸New York, New York, United States
Forest Investigative Site 034
🇵🇷San Juan, Puerto Rico
Forest Investigative Site 025
🇺🇸Staten Island, New York, United States
Forest Investigative Site 081
🇺🇸Bellevue, Washington, United States
Forest Investigative Site 043
🇺🇸Seattle, Washington, United States
Forest Investigative Site 082
🇺🇸Garden Grove, California, United States
Forest Investigative Site 085
🇺🇸Culver City, California, United States
Forest Investigative Site 084
🇺🇸Cerritos, California, United States
Forest Investigative Site 004
🇺🇸Oceanside, California, United States
Forest Investigative Site 022
🇺🇸Newport Beach, California, United States
Forest Investigative Site 090
🇺🇸Rancho Mirage, California, United States
Forest Investigative Site 044
🇺🇸South Miami, Florida, United States
Forest Investigative Site 072
🇺🇸Naperville, Illinois, United States
Forest Investigative Site 042
🇺🇸Lafayette, Indiana, United States
Forest Investigative Site 016
🇺🇸New York, New York, United States
Forest Investigative Site 086
🇺🇸Saint Charles, Missouri, United States
Forest Investigative Site 088
🇺🇸Canton, Ohio, United States
Forest Investigative Site 064
🇺🇸Middleburg Heights, Ohio, United States
Forest Investigative Site 066
🇺🇸Mason, Ohio, United States
Forest Investigative Site 055
🇺🇸Columbus, Ohio, United States
Forest Investigative Site 087
🇺🇸The Woodlands, Texas, United States
Forest Investigative Site 005
🇺🇸Houston, Texas, United States
Forest Investigative Site 030
🇺🇸Orem, Utah, United States
Forest Investigative Site 041
🇺🇸Charlottesville, Virginia, United States
Forest Investigative Site 057
🇺🇸Waukesha, Wisconsin, United States
Forest Investigative Site 014
🇺🇸Toms River, New Jersey, United States
Forest Investigative Site 019
🇺🇸Winter Park, Florida, United States
Forest Investigative Site 060
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 047
🇺🇸Smyrna, Georgia, United States
Forest Investigative Site 063
🇺🇸Libertyville, Illinois, United States
Forest Investigative Site 010
🇺🇸Oak Brook, Illinois, United States
Forest Investigative Site 046
🇺🇸Boston, Massachusetts, United States
Forest Investigative Site 069
🇺🇸Wichita Falls, Texas, United States
Forest Investigative Site 051
🇺🇸Orlando, Florida, United States
Forest Investigative Site 076
🇺🇸Bronx, New York, United States
Forest Investigative Site 079
🇺🇸Austin, Texas, United States
Forest Investigative Site 056
🇺🇸Milwaukee, Wisconsin, United States
Forest Investigative Site 007
🇺🇸San Diego, California, United States
Forest Investigative Site 054
🇺🇸San Diego, California, United States
Forest Investigative Site 048
🇺🇸Denver, Colorado, United States
Forest Investigative Site 050
🇺🇸Durham, North Carolina, United States
Forest Investigative Site 026
🇺🇸Miami, Florida, United States
Forest Investigative Site 075
🇺🇸Miami, Florida, United States
Forest Investigative Site 008
🇺🇸Tampa, Florida, United States
Forest Investigative Site 061
🇺🇸Indianapolis, Indiana, United States
Forest Investigative Site 089
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 011
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 015
🇺🇸Cincinnati, Ohio, 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 003
🇺🇸Portland, Oregon, United States
Forest Investigative Site 037
🇺🇸Coral Springs, Florida, United States
Forest Investigative Site 049
🇺🇸Gaithersburg, Maryland, United States
Forest Investigative Site 012
🇺🇸Rockville, Maryland, United States
Forest Investigative Site 073
🇺🇸New Orleans, Louisiana, United States
Forest Investigative Site 001
🇺🇸Charleston, South Carolina, United States
Forest Investigative Site 058
🇺🇸Albuquerque, New Mexico, United States