ECT in Clozapine Refractory Schizophrenia
Overview
- Phase
- Phase 1
- Intervention
- Electroconvulsive Therapy (ECT)
- Conditions
- Schizophrenia
- Sponsor
- Northwell Health
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded adequately to clozapine.
Detailed Description
ECT augmentation of clozapine will be compared to clozapine monotherapy in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
Investigators
George Petrides
Associate Professor of Psychiatry
Northwell Health
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1 ECT plus clozapine
Electroconvulsive therapy ECT plus clozapine for 8 weeks
Intervention: Electroconvulsive Therapy (ECT)
1 ECT plus clozapine
Electroconvulsive therapy ECT plus clozapine for 8 weeks
Intervention: Clozapine
2 Clozapine
Clozapine for 8 weeks
Intervention: Clozapine
Outcomes
Primary Outcomes
Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.
Time Frame: 8 Weeks
Response is defined as 40% reduction of symptoms in the psychotic symptom sub-scale (hallucinatory behavior, suspiciousness, conceptual disorganization, and unusual thought of content) of the Brief Psychiatric Rating Scale (BPRS) at the end of the 8-week study. BPRS assesses psychotic symptoms on a 18-item scale. The severity of each item is rated on a continuous scale from 1-7, with 1 being the least severe and 7 being most severe. Participants included in the study, at baseline had at least a moderate score of 4 on one of the four psychotic symptom sub-scale or a score of 12 on all four of these items combined (ranges 4 -28, with higher scores indicative of greater severity). A reduction of symptoms would be a sub-scale score which is 40% less than participants baseline score. If a participant enters the study with a sub-scale score of 15, to be considered a responder (at least a 40% reduction in symptoms score) his/her score must decrease by at least 6 points and be 9 or less.