Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Antidepressant + placebo
- Registration Number
- NCT00854100
- Lead Sponsor
- Forest Laboratories
- Brief Summary
This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 231
- Men and women, 18-65 years old
- Currently meet the DSM-IV-TR criteria for moderate to severe MDD without psychotic features.
- Previous failure to respond to adequate trials of one or two ADTs with less than 50% reduction in depressive symptoms during the present episode.
- DSM-IV-TR based diagnosis of an axis I disorder, other than MDD, or any axis I disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cariprazine 1.0 - 2.0 mg Antidepressant + cariprazine (1-2 mg/d) Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose Placebo Antidepressant + placebo Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Cariprazine 0.1 - 0.3 mg Antidepressant + cariprazine (0.1-0.3 mg/day) Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose
- Primary Outcome Measures
Name Time Method Montgomery-Asberg Depression Rating Scale (MADRS) Baseline (Week 8) to Week 16 The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. The primary efficacy parameter was the change in MADRS score totals from the scores taken at Baseline (Week 8) and during at least one more time point up to and including Week 16.
- Secondary Outcome Measures
Name Time Method Clinical Global Impression - Improvement (CGI-I) Week 16 The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale that, in this study, will be used to rate total improvement or worsening of mental illness starting at Visit 2 (Week 2) and taken at every visit through Visit 11 (Week 16). The patient will be rated on a scale from 1 to 7, 1 indicating that the patient is very much improved and 7 indicating that the patient is very much worse. The secondary efficacy parameter was the CGI-I total score at Week 16.
Trial Locations
- Locations (21)
Forest Investigative Site 031
🇺🇸Memphis, Tennessee, United States
Forest Investigative Site 023
🇺🇸Memphis, Tennessee, United States
Forest Investigative Site 033
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site
🇺🇸Seattle, Washington, United States
Forest Investigative Site 038
🇺🇸Scottsdale, Arizona, United States
Forest Investigative Site 040
🇺🇸Phoenix, Arizona, United States
Forest Investigative Site 042
🇺🇸Fall River, Massachusetts, United States
Forest Investigative Site 041
🇺🇸National City, California, United States
Forest Investigative Site 032
🇺🇸Raleigh, North Carolina, United States
Forest Investigative Site 034
🇺🇸Pittsfield, Massachusetts, United States
Forest Investigative Site 029
🇺🇸New York, New York, United States
Forest Investigative Site 043
🇺🇸Brooklyn, New York, United States
Forest Investigative Site 007
🇺🇸Jacksonville, Florida, United States
Forest Investigative Site 013
🇺🇸Los Alamitos, California, United States
Forest Investigative Site 025
🇺🇸Denver, Colorado, United States
Forest Investigative Site 012
🇺🇸West Palm Beach, Florida, United States
Forest Investigative Site 001
🇺🇸Bronx, New York, United States
Forest Investigative Site 039
🇺🇸New York, New York, United States
Forest Investigative Site 006
🇺🇸Media, Pennsylvania, United States
Forest Investigative Site 015
🇺🇸Portland, Oregon, United States
Forest Investigative Site 020
🇺🇸Mount Kisco, New York, United States