Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Procedure: Electroconvulsive Therapy (ECT); Drug: Clozapine

• Registration Number: NCT00042224
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study Start: 2000-12
• Study First Submitted: 2002-07-24
• Study First Submitted QC: 2002-07-25
• Study First Posted: 2002-07-26
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2015-04-09
• Results First Submitted QC: 2015-09-15
• Results First Posted: 2015-10-15
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 ECT plus clozapine	Electroconvulsive Therapy (ECT)	Electroconvulsive therapy ECT plus clozapine for 8 weeks
1 ECT plus clozapine	Clozapine	Electroconvulsive therapy ECT plus clozapine for 8 weeks
2 Clozapine	Clozapine	Clozapine for 8 weeks

Primary Outcome Measures

Name	Time	Method
Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.	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.

Trial Locations

Locations (1)

Zucker Hillside Hospital; 🇺🇸 Glen Oaks, New York, United States