Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia

Phase 3

Recruiting

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: Cariprazine

• Registration Number: NCT03817502
• Lead Sponsor: Gedeon Richter Plc.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-25
• Study Start: 2019-06-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• DSM-5 primary diagnosis of schizophrenia.
• Schizophrenia diagnosis confirmed by the K-SADS-PL administered at screening (Visit 1) by a trained clinician.
• PANSS score ≥ 70 and a score of ≥ 4 (moderate) on 2 or more of the 5 items on the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution), at screening (Visit 1) and baseline (Visit 2).
• CGI-S scale score of ≥ 4 (moderately ill) at screening (Visit 1) and baseline (Visit 2).

Exclusion Criteria

• Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
• Diagnosis of intellectual disability (IQ < 70).
• Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Visit 1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo capsules, oral administration, once daily.
Cariprazine 1.5 mg/d	Cariprazine	Cariprazine capsules, oral administration, once daily.
Cariprazine 4.5 mg/d	Cariprazine	Cariprazine capsules, oral administration, once daily.

Primary Outcome Measures

Name	Time	Method
Change from baseline in PANSS total score at Week 6	Baseline to Week 6	The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.

Trial Locations

Locations (57)

ProScience Research Group; 🇺🇸 Culver City, California, United States

Atlanta Center for Medical Research; 🇺🇸 Atlanta, Georgia, United States

Atlanta Behavioral Research, LLC; 🇺🇸 Atlanta, Georgia, United States

Bloomfield Hills MI; 🇺🇸 Bloomfield Hills, Michigan, United States

Precise Research Centers; 🇺🇸 Flowood, Mississippi, United States

UB Department of Psychiatry; 🇺🇸 Buffalo, New York, United States

Manhattan Behavioral Medicine PLLC; 🇺🇸 New York, New York, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Family Psychiatry of The Woodlands; 🇺🇸 The Woodlands, Texas, United States

Clinic of Child Psychiatry St. Nikolas; 🇧🇬 Sofia, Bulgaria

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