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 032
🇺🇸Tucson, Arizona, United States
Forest Investigative Site 018
🇺🇸Little Rock, Arkansas, United States
Forest Investigative Site 029
🇺🇸Little Rock, Arkansas, United States
Forest Investigative Site 084
🇺🇸Cerritos, California, United States
Forest Investigative Site 085
🇺🇸Culver City, California, United States
Forest Investigative Site 082
🇺🇸Garden Grove, California, United States
Forest Investigative Site 022
🇺🇸Newport Beach, California, United States
Forest Investigative Site 004
🇺🇸Oceanside, California, United States
Forest Investigative Site 090
🇺🇸Rancho Mirage, California, United States
Forest Investigative Site 078
🇺🇸Redlands, California, United States
Scroll for more (75 remaining)Forest Investigative Site 032🇺🇸Tucson, Arizona, United States