Summary

Eligibility
for people ages 18-64 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

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

Official Title

A Double-Blind, Placebo-Controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia

Keywords

Schizophrenia Cariprazine Cariprazine 3.0 mg/day Cariprazine 4.5 mg/day

Eligibility

You can join if…

Open to people ages 18-64

  • 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.

You CAN'T join if...

  • 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
  • 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.

Locations

  • University of California San Diego/UCSD
    San Diego California 92103-8229 United States
  • Synergy San Diego
    National City California 91950 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Allergan
ID
NCT03593213
Phase
Phase 3
Study Type
Interventional
Last Updated