Summary

for people ages 18-64 (full criteria)
at San Diego, California and other locations
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 accepting new patients
    San Diego California 92103-8229 United States
  • Artemis Institute for Clinical Research withdrawn
    San Diego California 92103 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Forest Laboratories
Links
Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR‐CTRegistration@Allergan.com for assistance.
ID
NCT03593213
Phase
Phase 3
Study Type
Interventional
Last Updated