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Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
George Petrides, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00042224
First received: July 24, 2002
Last updated: September 15, 2015
Last verified: September 2015

July 24, 2002
September 15, 2015
December 2000
July 2008   (final data collection date for primary outcome measure)
Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
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. 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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Complete list of historical versions of study NCT00042224 on ClinicalTrials.gov Archive Site
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Electroconvulsive Therapy in Clozapine Refractory Schizophrenia
ECT in Clozapine Refractory Schizophrenia
This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded adequately to clozapine.
ECT augmentation of clozapine will be compared to clozapine monotherapy in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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
  • Experimental: 1 ECT plus clozapine
    Electroconvulsive therapy ECT plus clozapine for 8 weeks
    Interventions:
    • Procedure: Electroconvulsive Therapy (ECT)
    • Drug: Clozapine
  • Active Comparator: 2 Clozapine
    Clozapine for 8 weeks
    Intervention: Drug: Clozapine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00042224
R01MH060390, R01MH060390, DSIR AT-SO
Yes
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George Petrides, North Shore Long Island Jewish Health System
Northwell Health
National Institute of Mental Health (NIMH)
Principal Investigator: Georgios Petrides, MD New Jersey Medical School
Northwell Health
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP