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Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Janssen, LP |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00061802 |
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
Condition | Intervention | Phase |
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Schizophrenia Schizoaffective Disorder |
Drug: risperidone, quetiapine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind 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 |
Estimated Enrollment: | 225 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | February 2004 |
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.)
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Current diagnosis of an acute exacerbation of either schizophrenia or schizoaffective disorder
Study ID Numbers: | CR002890 |
Study First Received: | June 4, 2003 |
Last Updated: | December 1, 2006 |
ClinicalTrials.gov Identifier: | NCT00061802 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neurotransmitter Agents Tranquilizing Agents Risperidone Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Serotonin |
Schizophrenia Quetiapine Dopamine Mental Disorders Psychotic Disorders Dopamine Agents Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Risperidone Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions |
Schizophrenia Serotonin Antagonists Serotonin Agents Pathologic Processes Mental Disorders Therapeutic Uses Dopamine Agents Psychotic Disorders Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |