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Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00042224
Recruitment Status : Completed
First Posted : July 26, 2002
Results First Posted : October 15, 2015
Last Update Posted : May 15, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
George Petrides, Northwell Health

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

Condition or disease Intervention/treatment Phase
Schizophrenia Procedure: Electroconvulsive Therapy (ECT) Drug: Clozapine Phase 1 Phase 2

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Clozapine

Arm Intervention/treatment
Experimental: 1 ECT plus clozapine
Electroconvulsive therapy ECT plus clozapine for 8 weeks
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
Drug: Clozapine
Patients with psychotic symptoms will receive clozapine
Other Name: Clozaril

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00042224

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United States, New York
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Northwell Health
National Institute of Mental Health (NIMH)
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Principal Investigator: Georgios Petrides, MD New Jersey Medical School
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Responsible Party: George Petrides, Associate Professor of Psychiatry, Northwell Health 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
Keywords provided by George Petrides, Northwell Health:
Electroconvulsive Therapy
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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