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

Sponsor:	AstraZeneca
Collaborator:	University of North Carolina
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00034892

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Efficacy and Tolerability of Olanzapine, Quetiapine and Risperidone in the Treatment of First Episode Psychosis: A Randomized Double Blind 52-Week Comparison

Resource links provided by NLM:

MedlinePlus related topics: Child Mental Health Mental Disorders Mental Health Psychotic Disorders Schizophrenia

Drug Information available for: Risperidone Olanzapine

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Study Start Date:	March 2002
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00034892 History of Changes
Other Study ID Numbers:	5077IL/0114
Study First Received:	May 2, 2002
Last Updated:	November 29, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Risperidone
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents

Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012