Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia

NCT00694707 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 732

Last updated 2019-06-12

Study results available
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Summary

This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.

Conditions

Interventions

DRUG

Placebo

Placebo was supplied in capsules.

DRUG

Cariprazine

Cariprazine was supplied in capsules

DRUG

Risperidone

Risperidone was supplied in capsules

Sponsors & Collaborators

  • Gedeon Richter Ltd.

    collaborator INDUSTRY
  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Suresh Durgam, MD · Forest Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States
  • India
  • Malaysia
  • Russia
  • Ukraine

Study Locations

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Entities

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 NCT00694707 on ClinicalTrials.gov