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Safety and Efficacy of Cariprazine in Schizophrenia | Clinical Trials | Clareo Health

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Safety and Efficacy of Cariprazine in Schizophrenia

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia

NCT01104779•Forest Laboratories

View on ClinicalTrials.gov

Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients who have provided informed consent prior to any study specific procedures
•Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
•Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
•Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
•Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria

•Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
•Patients in their first episode of psychosis
•Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
•Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
•Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
•Substance abuse or dependence within the prior 3 months

Locations (41)

Forest Investigative Site 48

Costa Mesa, California, United States

Forest Investigative Site 50

Long Beach, California, United States

Forest Investigative Site 42

Paramount, California, United States

Forest Investigative Site 054

San Diego, California, United States

Forest Investigative Site 41

Kissimmee, Florida, United States

Forest Investigative Site 055

Atlanta, Georgia, United States

Forest Investigative Site 44

Rockville, Maryland, United States

Forest Investigative Site 45

St Louis, Missouri, United States

Forest Investigative Site 52

Las Vegas, Nevada, United States

Forest Investigative Site 40

Cedarhurst, New York, United States

Key Dates

Start Date

April 27, 2010

Primary Completion Date

December 15, 2011

Completion Date

December 15, 2011

Last Updated

November 14, 2018

Enrollment

446

ACTUAL participants

Conditions

Schizophrenia

Interventions

Cariprazine

DRUG

Placebo

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of Cariprazine in Schizophrenia

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

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