Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
Part of paid clinical trials in Culver City, California.
- Sponsor
- Gedeon Richter Plc.
- Study ID
- NCT03817502
- Phase
- PHASE3
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 13 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cariprazine — DRUGCariprazine capsules, oral administration, once daily.
- Placebo — DRUGMatching placebo capsules, oral administration, once daily.
Study Details
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
Key Dates
- Start date
- Jun 6, 2019
- Status verified
- Oct 2025
- Primary completion
- Dec 15, 2026
- Completion
- Dec 15, 2026
Study Design
- Enrollment
- 330 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cariprazine 1.5 mg/dCariprazine capsules, oral administration, once daily.
- Experimental: Cariprazine 4.5 mg/dCariprazine capsules, oral administration, once daily.
- Placebo Comparator: PlaceboMatching placebo capsules, oral administration, once daily.
Primary Outcome Measure
Change from baseline in PANSS total score at Week 6 [ Time Frame: Baseline to Week 6 ]
Central Contacts
- Balázs Lázár+36 1 432 6437
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| ProScience Research Group | Culver City | California | 90230 | - |
| Atlanta Behavioral Research, LLC | Atlanta | Georgia | 30338 | - |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | - |
| Bloomfield Hills MI | Bloomfield Hills | Michigan | 48302 | - |
| Precise Research Centers | Flowood | Mississippi | 39232 | - |
| UB Department of Psychiatry | Buffalo | New York | 142515 | - |
| Manhattan Behavioral Medicine PLLC | New York | New York | 10036 | - |
| University of Cincinnati | Cincinnati | Ohio | 45219 | - |
| Family Psychiatry of The Woodlands | The Woodlands | Texas | 77381 | - |
Find similar trials in Culver City, CA
By condition
By specialty
Related Studies
- Database Registry for Neural Network Biomarkers in PsychosisRecruiting · University of Texas Southwestern Medical Center · Dallas, Texas
- Ocrelizumab for Psychosis by AutoimmunityPHASE1/PHASE2 · Recruiting · The Methodist Hospital Research Institute · Houston, Texas
- Imaging Synapses With [11C] UCB-J in the Human BrainPHASE1 · Recruiting · Davidzon, Guido, M.D. · Palo Alto, California
- Effects of Brain Stimulation on Cognition, Oscillations and GABA Levels in SchizophreniaRecruiting · University of California, Davis · Sacramento, California