Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

Study Overview
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Brief Summary
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This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded adequately to clozapine.

Detailed Description
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ECT augmentation of clozapine will be compared to clozapine monotherapy in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.

Official Title
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ECT in Clozapine Refractory Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Procedure: Electroconvulsive Therapy (ECT)
* Drug: Clozapine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosis of schizophrenia according to DSM-IV criteria Duration of illness 2 years or greater Resistance to at least 2 antipsychotics Clozapine resistance Capacity to give informed consent For women of childbearing capacity, a negative pregnancy test and patient agreement to use a medically accepted form of contraception Brief Psychiatric Rating Scale score of at least a 4 on one of the four psychotic items on the psychotic sub-scale or a score of 12 on these 4 items combined. Clinical Global Impressions (CGI) - severity rating of at least moderate (score of 4) Receiving at least two 400 mg doses of chlorpromazine equivalents for at least 4 weeks (may include newer antipsychotics) Having substantial psychotic symptoms despite at least 12 weeks of treatment (at least 8 weeks at a consistent dose) Exclusion criteria schizoaffective disorder; bipolar disorder; current affective episode; Electroconvulsive Therapy (ECT) within the past 6 months history of epilepsy; severe neurological or systemic disorder that could significantly affect cognition, behavior, or mental status (other than tardive dyskinesia or neuroleptic-induced parkinsonism); psychoactive substance dependence (other than nicotine or caffeine) within 1 month prior to entering the study a score of less than 18 on the 24-item Hamilton Depression Rating Scale (HAM-D) clinical determination that mood stabilizers were necessary and therefore could not be discontinued. pregnancy. affective disorders and prominent depressive symptoms because ECT is well known to be effective in those situations, and we wanted to avoid contamination of our results by improvement solely driven by the treatment of the affective symptoms.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 ECT plus clozapine<br>Electroconvulsive therapy ECT plus clozapine for 8 weeks | Procedure: Electroconvulsive Therapy (ECT)<br>* ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.<br>Drug: Clozapine<br>* Patients with psychotic symptoms will receive clozapine<br>* Other names: Clozaril;|
| Active Comparator: 2 Clozapine<br>Clozapine for 8 weeks | Drug: Clozapine<br>* Patients with psychotic symptoms will receive clozapine<br>* Other names: Clozaril;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group. | 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. | 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroconvulsive Therapy