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

G

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

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

Trial contacts and locations

57

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Central trial contact

Balázs Lázár

Data sourced from clinicaltrials.gov

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