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

NCT03593213 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 587

Last updated 2022-04-11

Study results available
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Summary

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

Conditions

Interventions

DRUG

Cariprazine

Cariprazine capsules, oral administration, once daily.

DRUG

Placebo

Matching placebo capsules, oral administration, once daily.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-30
Primary Completion
2021-02-11
Completion
2021-02-11
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Malaysia
  • Poland
  • Puerto Rico
  • Romania
  • Serbia
  • South Korea
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03593213 on ClinicalTrials.gov