A study to evaluate pharmacokinetics, safety and tolerability of Cariprazine in adolescent subjects with schizophrenia compared to adults

Phase 1

• Conditions: Schizophrenia, Schizoaffective- and Schizophreniform Disorders; MedDRA version: 20.0Level: HLTClassification code 10039620Term: Schizoaffective and schizophreniform disordersSystem Organ Class: 100000004873; MedDRA version: 20.0Level: HLTClassification code 10039631Term: Schizophrenia NECSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2016-002327-29-BG
• Lead Sponsor: Gedeon Richter Plc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-24
• Study Completion: 2018-06-19
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

1.All patients are required to have a diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder according to the DSM-5.
2.Adolescent patients have to be between the ages of either 13 to <15 years or 15 to <18 years. Adult patients must be 18 - 40 years of age.
3.Patients must be otherwise healthy, on the basis of screening medical and surgical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests.
4.Patients must have negative urine drug screens and alcohol breath tests.
Are the trial subjects under 18? yes
Number of subjects for this age range: 54
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Current DSM-5 diagnosis other than schizophrenia, schizoaffective disorder or schizophreniform disorder.
2.Other neurological or behavioral disorders that may interfere with the conduct or interpretation of the study.
3.History of drug abuse according to DSM 5 and/or positive test result from the urine drug screen (UDS).
4.Regular use of alcohol or alcohol abuse or positive alcohol breath test.
5.Being at significant risk of suicide according to the Investigator judgment, based upon all available source of information including C-SSRS.
6.Clinically significant disease state, in the opinion of the examining physician, in any body system.
7.Abnormal and clinically significant results on physical examination, vital signs, medical history, serum chemistry, hematology, or urinalysis.
8.Clinically significant abnormal electrocardiogram (ECG) results.
9.Positive test results for anti–human immunodeficiency virus, hepatitis B surface antigen, anti–hepatitis C virus antibody at screening.
10.Taken strong CYP3A4 inhibitors or inducers within 30 days before first administration of IMP until the last PK sampling.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified