Efficacy and Safety of Two Atypical Antipsychotics vs. Placebo in Patients With an Acute Exacerbation of Either Schizophrenia or Schizoaffective Disorder

NCT ID: NCT00061802

Last Updated: 2012-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2004-02-29

Brief Summary

A study to evaluate the efficacy and safety of two atypical antipsychotics vs. placebo in patients with an acute exacerbation of either schizophrenia or schizoaffective disorder

Detailed Description

This study was intended to compare the efficacy and safety of risperidone, quetiapine, and placebo in the treatment of patients with acute exacerbations of schizophrenia or schizoaffective disorder. The primary tested hypothesis was a comparison of the efficacy of risperidone and quetiapine (active combined group) to placebo. Other a priori hypotheses tested included comparison of the onset of antipsychotic effect of risperidone to quetiapine and placebo, and to evaluate the efficacy, safety, and cost of risperidone compared with quetiapine in the treatment of subjects with an acute exacerbation of schizophrenia or schizoaffective disorder.

During the first phase of the study (15 days), patients randomized to risperidone were titrated from 1 mg to 4 mg or from 1 mg to 6 mg per day, depending on body weight. Patients randomized to quetiapine were titrated from 50 mg to 400 mg or from 50 mg to 600 mg per day, depending on body weight. Based on investigators determination of patient clinical response, patients in the quetiapine group could be titrated to a maximum of 600 mg or 800 mg per day depending on body weight.

During the second phase of the study (days 15 - 42), patients continue to take the dose of study medication taken in the first phase, but additional psychotropic medication could be added as clinically necessary to control symptoms in patients who remained sufficiently symptomatic (defined as a certain minimum value on a clinical global severity scale.)

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

risperidone, quetiapine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Current diagnosis of an acute exacerbation of either schizophrenia or schizoaffective disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen, LP

INDUSTRY

Sponsor Role: collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Locations

San Diego, California, United States

Hoffman Est, Illinois, United States

Lake Charles, Louisiana, United States

Jackson, Mississippi, United States

Visakhapatnam, Missouri, United States

The Bronx, New York, United States

Oklahoma City, Oklahoma, United States

Aurangabad, , India

New Delhi, , India

Orange, , India

San Diego, , India

Lucknow, , Romania

Richmond, , Romania

Countries

United States; India; Romania

References

Gharabawi GM, Greenspan A, Rupnow MF, Kosik-Gonzalez C, Bossie CA, Zhu Y, Kalali AH, Awad AG. Reduction in psychotic symptoms as a predictor of patient satisfaction with antipsychotic medication in schizophrenia: data from a randomized double-blind trial. BMC Psychiatry. 2006 Oct 20;6:45. doi: 10.1186/1471-244X-6-45.

Reference Type: RESULT

PMID: 17054789 (View on PubMed)

Other Identifiers

CR002890

Identifier Type: -

Identifier Source: org_study_id