Schizophrenia
Conditions
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.
Interventions
DRUGCariprazine
Cariprazine capsules, oral administration, once daily.
DRUGPlacebo
Matching placebo capsules, oral administration, once daily.
Sponsors
Gedeon Richter Plc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Bulgaria, Colombia, Mexico, Romania, Russia, Serbia, Ukraine, United States
Contacts
Primary ContactBalázs Lázár
Outcome results
None listed