Electroconvulsive Therapy in Clozapine Refractory Schizophrenia
NCT ID: NCT00042224
Last Updated: 2017-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
39 participants
INTERVENTIONAL
2000-12-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1 ECT plus clozapine
Electroconvulsive therapy ECT plus clozapine for 8 weeks
Electroconvulsive Therapy (ECT)
ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
Clozapine
Patients with psychotic symptoms will receive clozapine
2 Clozapine
Clozapine for 8 weeks
Clozapine
Patients with psychotic symptoms will receive clozapine
Interventions
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Electroconvulsive Therapy (ECT)
ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
Clozapine
Patients with psychotic symptoms will receive clozapine
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Northwell Health
OTHER
Responsible Party
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George Petrides
Associate Professor of Psychiatry
Principal Investigators
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Georgios Petrides, MD
Role: PRINCIPAL_INVESTIGATOR
New Jersey Medical School
Locations
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Zucker Hillside Hospital
Glen Oaks, New York, United States
Countries
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Other Identifiers
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