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CAFE Comparison of Atypicals in First Episode of Psychosis

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Psychotic Disorders
Mental Disorders
Schizophrenia
Mental Health

Treatments

Drug: Olanzapine, risperidone

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00034892
5077IL/0114

Details and patient eligibility

About

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.

Sex

All

Ages

16 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

26

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Data sourced from clinicaltrials.gov

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