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

AbbVie

Status and phase: Terminated; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Cariprazine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03593213

RGH-MD-24

2017-000818-34 (EudraCT Number)

Details and patient eligibility

About

1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 milligram per day (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

Enrollment: 587 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
• 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.
• Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for DSM-5 (SCID-5).
• Positive and Negative Syndrome Scale (PANSS) total score >= 70 and <= 120 at Visit 1 and Visit 2 (Day 1).
• Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour; 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 Participants who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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587 participants in 4 patient groups, including a placebo group

Cariprazine 4.5 mg/day (Open-label Treatment Period)

Experimental group

Description:

Cariprazine 1.5 mg capsules orally once daily at Week 1, titrated to 3.0 mg capsules orally once daily at Week 2 and then titrated to 4.5 mg orally once daily from Week 3 through Week 18 in the Open-label Treatment Period.

Treatment:

Drug: Cariprazine

Placebo (Double-blind Treatment Period)

Placebo Comparator group

Description:

Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.

Treatment:

Drug: Placebo

Cariprazine 3.0 mg/day (Double-blind Treatment Period)

Experimental group

Description:

Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.

Treatment:

Drug: Cariprazine

Cariprazine 4.5 mg/day (Double-blind Treatment Period)

Experimental group

Description:

Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.

Treatment:

Drug: Cariprazine