Electroconvulsive Therapy in Clozapine Refractory Schizophrenia
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ClinicalTrials.gov Identifier: NCT00042224 |
Recruitment Status :
Completed
First Posted : July 26, 2002
Results First Posted : October 15, 2015
Last Update Posted : May 15, 2017
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Condition or disease | Intervention/treatment | Phase |
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Schizophrenia | Procedure: Electroconvulsive Therapy (ECT) Drug: Clozapine | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | ECT in Clozapine Refractory Schizophrenia |
Study Start Date : | December 2000 |
Actual Primary Completion Date : | July 2008 |
Actual Study Completion Date : | July 2008 |

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

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042224
United States, New York | |
Zucker Hillside Hospital | |
Glen Oaks, New York, United States, 11004 |
Principal Investigator: | Georgios Petrides, MD | New Jersey Medical School |
Responsible Party: | George Petrides, Associate Professor of Psychiatry, Northwell Health |
ClinicalTrials.gov Identifier: | NCT00042224 |
Other Study ID Numbers: |
R01MH060390 ( U.S. NIH Grant/Contract ) R01MH060390 ( U.S. NIH Grant/Contract ) DSIR AT-SO ( Other Identifier: NorthShore LIJ Health System ) |
First Posted: | July 26, 2002 Key Record Dates |
Results First Posted: | October 15, 2015 |
Last Update Posted: | May 15, 2017 |
Last Verified: | April 2017 |
Electroconvulsive Therapy |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Clozapine Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs GABA Antagonists GABA Agents |