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A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia

NCT01412060 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 765

Last updated 2018-07-06

Study results available
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Summary

The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.

Conditions

Interventions

DRUG

Placebo

Placebo was supplied in capsules.

DRUG

Cariprazine

Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.

Sponsors & Collaborators

  • Gedeon Richter Ltd.

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Willie Earley · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-09-27
Primary Completion
2014-09-03
Completion
2014-09-03

Countries

  • United States
  • India
  • Romania
  • Slovakia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01412060 on ClinicalTrials.gov