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CATIE- Schizophrenia Trial

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00014001
First received: April 6, 2001
Last updated: April 16, 2014
Last verified: October 2006
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: perphenazine
Drug: olanzapine
Drug: quetiapine
Drug: risperidone
Drug: ziprasidone
Drug: clozapine
Drug: fluphenazine decanoate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial)

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 1600
Study Start Date: December 2000
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • 18-65 years old
  • DSM-IV diagnosis of schizophrenia
  • adequate capacity to consent

Exclusion

  • Intolerance or failure to respond to one of the treatments
  • Diagnoses of schizoaffective disorder, mental retardation, pervasive developmental disorder, delirium, dementia, amnesia
  • First episode of schizophrenia
  • Women currently pregnant or breast-feeding
  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: NCT00014001

  Show 54 Study Locations
Sponsors and Collaborators
Investigators
Study Director: Jeffrey A Lieberman, MD University of North Carolina
  More Information

Publications:

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

ClinicalTrials.gov Identifier: NCT00014001     History of Changes
Other Study ID Numbers: N01 MH090001-06, N01MH90001-SZ, DSIR AT
Study First Received: April 6, 2001
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Antipsychotic Treatment
Effectiveness

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Fluphenazine
Fluphenazine depot
Fluphenazine enanthate
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014