Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014001
Status:
COMPLETED
Last Update Posted:
2015-06-17
First Post:
2001-04-06
Brief Title:
CATIE- Schizophrenia Trial
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia CATIE Schizophrenia Trial
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ziprasidoneand 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR AT | None | None | None |
| N01MH90001-SZ | None | None | None |