Cariprazine hydrochloride for Schizophrenia

Inclusion criteria

• {"criterion_text":"- In addition to the informed consent given by the parent(s) or legal representative assent of the patient must be obtained for participating in the study prior to any study related procedures\n- Male or female patients must be 13 to <18 years of age at the time of obtaining the patient's informed consent or assent. Patients who turn 18 during RGH-MD-20 are permitted to continue in this trial. De novo patients are required to be <18 years of age at screening.\n- Patients with a DSM-5 primary diagnosis of schizophrenia, which has been confirmed by the K-SADS-PL administered by a trained clinician\n- PANSS total score ≤ 60 at Screening and Baseline\n- Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8 and G14 at Screening and Baseline\n- CGI-S score ≤ 4 at Screening and Baseline\n- Patients must agree to sexual abstinence or to use a highly effective contraceptive method (see Section 16.1) during the study and for 10 weeks after the last dose of the IMP. Male patients must agree to refrain from donating sperm during this period. Women using systematically acting hormonal contraceptives should add a second barrier method (e.g. male condom, diaphragm or cervical cap)"}

Exclusion criteria

• {"criterion_text":"- Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition\n- Patient has a history of meeting DSM-5 diagnosis for any substancerelated disorder (except caffeine- and tobaccorelated) within the 3 months before Screening\n- Patient with acute or unstable medical condition, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency (specifically any degree of jaundice), uncorrected hyper- or hypothyroidism, acute systemic infection, renal, gastrointestinal, respiratory, or cardiovascular disease.\n- Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 antipsychotic trials of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the drug's package insert)\n- Patient requires concomitant treatment with moderate or strong cytochrome P450 (CYP) 3A4 inhibitors or inducers. If applicable and the patient's condition allows without risk, these drugs must be discontinued 7 days or at least 5 half-lives of the drug (whichever is longer) prior to Baseline (Visit 2)."}

Primary endpoints

• {"endpoint_text":"- Primary Outcome Measures: adverse events, clinical laboratory assessments including HbA1c, prolactin, FSH and LH, menstrual cycle assessment, vital signs, weight, physical examination, ECG, C-SSRS, CDSS, AIMS, BARS, SAS, UKU and Tanner staging","definition_or_measurement_approach":"Safety and tolerability endpoints measured by adverse event reporting, clinical laboratory assessments (including HbA1c, prolactin, FSH, LH), menstrual cycle assessment, vital signs, weight, physical examinations, ECG, and standardized rating scales (C-SSRS, CDSS, AIMS, BARS, SAS, UKU) and Tanner staging."}

Secondary endpoints

• {"endpoint_text":"- \"Additional Outcome Measures: Effectiveness measures: PANSS, CGI-S, CGI-I, C-GAS, CDR system Health-related outcome measures: CGSQ, PQ-LES-Q Per p Additional Outcome Measures: Effectiveness measures: PANSS, CGI-S, CGI-I, C-GAS, CDR system Health-related outcome measures: CGSQ, PQ-LES-Q Per p\"","definition_or_measurement_approach":"Effectiveness assessed using PANSS, CGI-S, CGI-I, C-GAS, CDR system; health-related outcomes assessed by CGSQ and PQ-LES-Q."}

Germany

Earliest CTIS Part Ii Submission Date

27-06-2024

Latest Decision Or Authorization Date

22-07-2024

Processing Time Days

25

Number Of Sites

2

Number Of Participants

1

Bulgaria

Earliest CTIS Part Ii Submission Date

27-06-2024

Latest Decision Or Authorization Date

02-06-2025

Processing Time Days

340

Number Of Sites

3

Number Of Participants

30

Romania

Earliest CTIS Part Ii Submission Date

27-06-2024

Latest Decision Or Authorization Date

14-07-2025

Processing Time Days

382

Number Of Sites

1

Number Of Participants

8

Primary sponsor

Full Name

Gedeon Richter Plc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Hungary

Contract research organisations

Name

Labcorp Central Laboratory Services SARL

Responsibilities

Clinical haematology, Serology/ endocrinology, Analytical chemistry

Name

Suvoda LLC

Name

Signant Health Global LLC

Responsibilities

Scales and Rater Certification & Supply

Name

Medidata Solutions Inc.

Name

eResearchTechnology GmbH

Responsibilities

ECG analysis/ review

Third parties

• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Clinical haematology, Serology/ endocrinology, Analytical chemistry","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Scales and Rater Certification & Supply","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"ECG analysis/ review","organisation_type":"Pharmaceutical company"}