CAFE Comparison of Atypicals in First Episode of Psychosis - Full Text View

Purpose

The purpose of this study is to compare the effectiveness, tolerability, and efficacy of the currently available atypical antipsychotic drugs olanzapine (2.5-20 mg/day), quetiapine (100-800 mg/day) and risperidone (0.5-4 mg/day) in patients with schizophrenia, schizophreniform disorder, or schizoaffective disorder who are experiencing their first psychotic episode.

Condition	Intervention	Phase
Schizophrenia Psychotic Disorders Mental Health Mental Disorders	Drug: Olanzapine, risperidone	Phase IV

MedlinePlus related topics:

Child Mental Health Mental Health Psychotic Disorders Schizophrenia

Drug Information available for:

Risperidone Quetiapine Quetiapine fumarate Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Efficacy and Tolerability of Olanzapine, Quetiapine and Risperidone in the Treatment of First Episode Psychosis: A Randomized Double Blind 52-Week Comparison

Eligibility

Ages Eligible for Study:	16 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must meet criteria for schizophreniform disorder, schizophrenia, or schizoaffective disorder with psychotic symptoms lasting 1-60 months
Psychotic symptoms must have persisted at least one month, and not more thn 5 years (60 months)
Patients must have no previous history of drug treatment (greater than a total of 16 weeks) with antipsychotics

Exclusion Criteria:

Patients with history of psychotic disorder with recovery period of at least 3 months
Female patients who are pregnant or nursing
Patients with a known history of mental retardation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034892

Show 26 Study Locations

Sponsors and Collaborators

AstraZeneca

University of North Carolina

More Information

Publications indexed to this study:

Perkins DO, Gu H, Weiden PJ, McEvoy JP, Hamer RM, Lieberman JA; Comparison of Atypicals in First Episode study group. Predictors of treatment discontinuation and medication nonadherence in patients recovering from a first episode of schizophrenia, schizophreniform disorder, or schizoaffective disorder: a randomized, double-blind, flexible-dose, multicenter study. J Clin Psychiatry. 2008 Jan;69(1):106-13.

Keefe RS, Sweeney JA, Gu H, Hamer RM, Perkins DO, McEvoy JP, Lieberman JA. Effects of olanzapine, quetiapine, and risperidone on neurocognitive function in early psychosis: a randomized, double-blind 52-week comparison. Am J Psychiatry. 2007 Jul;164(7):1061-71.

McEvoy JP, Lieberman JA, Perkins DO, Hamer RM, Gu H, Lazarus A, Sweitzer D, Olexy C, Weiden P, Strakowski SD. Efficacy and tolerability of olanzapine, quetiapine, and risperidone in the treatment of early psychosis: a randomized, double-blind 52-week comparison. Am J Psychiatry. 2007 Jul;164(7):1050-60.

Study ID Numbers:	5077IL/0114
First Received:	May 2, 2002
Last Updated:	October 12, 2006
ClinicalTrials.gov Identifier:	NCT00034892
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia

Quetiapine

Dopamine

Mental Disorders

Risperidone

Olanzapine

Psychotic Disorders

Serotonin

Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Disease

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Gastrointestinal Agents

Psychotropic Drugs

Antiemetics

Central Nervous System Depressants

Dopamine Antagonists

Antipsychotic Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

Serotonin Antagonists

Pathologic Processes

Serotonin Agents

Autonomic Agents

Therapeutic Uses

Dopamine Agents

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2008

Sponsors and Collaborators:	AstraZeneca University of North Carolina
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00034892