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

Gedeon Richter

Status and phase: Enrolling; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Cariprazine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03817502

2018-004006-26 (EudraCT Number)

RGH-MD-20

Details and patient eligibility

About

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

Enrollment: 330 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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330 participants in 3 patient groups, including a placebo group

Cariprazine 1.5 mg/d

Experimental group

Description:

Cariprazine capsules, oral administration, once daily.

Treatment:

Drug: Cariprazine

Cariprazine 4.5 mg/d

Experimental group

Description:

Cariprazine capsules, oral administration, once daily.

Treatment:

Drug: Cariprazine

Placebo

Placebo Comparator group

Description:

Matching placebo capsules, oral administration, once daily.

Treatment:

Drug: Placebo