Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia

• Status: Terminated
• Trial end date: 2021-02-11
• Target enrollment: 0
• Participant gender: All

Summary

1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 mg/d compared with placebo in prevention of relapse in patients with schizophrenia

2. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with schizophrenia who were initially stabilized on a target dose of 4.5 mg/d

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Cariprazine

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia for a minimum of 1 year before Visit 1.

• Ability to follow study instructions, complete study assessment tools with minimal assistance and no alteration to the assessment tools, and likely to complete all required visits.

• Patient meets DSM-5 criteria for schizophrenia as determined by SCID-5.

• PANSS total score ≥ 70 and ≤ 120 at Visit 1 and Visit 2.

• Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behavior; P6: suspiciousness/persecution at Visit 1 and Visit 2.

Exclusion Criteria:

• Currently meeting DSM-5 criteria for any of the following:

• Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders

• Bipolar I and II disorder

• Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder

• History of meeting DSM-5 criteria for substance-related disorders (excluding caffeine-related and tobacco-related disorders) within the prior 3 months before Visit 1.

• Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study.

• Female patients who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.