CATIE- Schizophrenia Trial
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention
      Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the
      long-term effects and usefulness of antipsychotic medications in persons with schizophrenia.
      It is designed for people with schizophrenia who may benefit from a medication change. The
      study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone,
      clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine
      decanoate). All participants will receive an initial comprehensive medical and psychiatric
      evaluation and will be closely followed throughout the study. For most participants the study
      will last up to 18 months. Everyone in the study will be offered an educational program about
      schizophrenia and family members will be encouraged to participate.
    

Detailed description: 
      This trial will consist of 1600 patients with schizophrenia for whom a medication change may
      be indicated for reasons of limited efficacy or tolerability. All patients will receive some
      psychosocial treatment through study participation. Research participants and their family
      members will be offered psychosocial interventions directed at improving patient and family
      understanding of the illness, decreasing the burden of illness in the family, maximizing
      treatment adherence, minimizing relapse, enhancing access to a range of community-based
      rehabilitative services and improving study retention.

      Phase I: Patients will be randomly assigned to one of five treatment conditions for up to 18
      months:

        1. 320 begin double-blind treatment with perphenazine (PER)

        2. 320 begin double-blind treatment with olanzapine (OLZ)

        3. 320 begin double-blind treatment with quetiapine (QUET)

        4. 320 begin double-blind treatment with risperidone (RIS)

        5. 220 begin double-blind treatment with ziprasidone (ZIP)

      Phase IA: 100 patients screened and found to have tardive dyskinesia who would otherwise be
      eligible for the study will be randomly assigned to one of the four atypical drugs in Phase
      IA.

      Phase IB: Patients who fail treatment with perphenazine in Phase I will be randomly assigned
      to olanzapine, quetiapine, or risperidone in Phase IB.

      Phase II: Patients who discontinue their initial assigned atypical antipsychotic treatment in
      Phase I, IA, or IB for any non-administrative reason will proceed to their second assigned
      treatment (third for Phase IB patients) and will be followed for up to the remainder of their
      18-month participation, as follows:

        1. Patients originally assigned to one of the newer atypical antipsychotics who discontinue
           due to efficacy failure will be randomly assigned to double-blind treatment with one of
           the other two newer atypical antipsychotics (OLZ, RIS, QUET) which they had not
           previously received (50%) or with open label clozapine (50%).

        2. Patients originally assigned to one of the newer atypical antipsychotics who discontinue
           due to tolerability failure will be randomly assigned to double-blind treatment with one
           of the other newer atypical antipsychotics (OLZ, RIS, QUET) which they had not
           previously received (50%), or with ziprasidone (50%). Until ziprasidone is activated,
           all patients will be assigned to one of the other atypical antipsychotics.

      Phase II will last at least 6 months, even if that means participants stay in the study for
      more than 18 months

      Phase III: Patients who discontinue Phase II will be recommended open treatment with the
      preferred regimen based on their treatment history in the study. The treatment options
      include clozapine, newer atypical antipsychotic (olanzapine, risperidone, quetiapine,
      ziprazidone, and aripiprazole), fluphenazine decanoate, perphenazine, and dual antipsychotic
      therapy using two of these drugs.

      Note: All treatments will be double-blinded in treatment Phases I and II except for
      clozapine.
    

Intervention name(s): perphenazine; olanzapine; quetiapine; risperidone; ziprasidone; clozapine; fluphenazine decanoate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Olanzapine; Risperidone; Quetiapine Fumarate; Ziprasidone; Clozapine; Perphenazine; Fluphenazine; Fluphenazine depot; Fluphenazine enanthate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Antipsychotic Treatment; Effectiveness