CAFE Comparison of Atypicals in First Episode of Psychosis

This study has been completed.
Sponsor:
Collaborator:
University of North Carolina
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00034892
First received: May 2, 2002
Last updated: January 3, 2013
Last verified: January 2013
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
ClinicalTrials.gov Identifier: NCT00034892     History of Changes
Other Study ID Numbers: 5077IL/0114
Study First Received: May 2, 2002
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Schizophrenia
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Olanzapine
Risperidone
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014