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

Condition Intervention Phase
Schizophrenia
Procedure: Electroconvulsive Therapy (ECT)
Drug: Clozapine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ECT in Clozapine Refractory Schizophrenia

Resource links provided by NLM:


Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • 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.


Enrollment: 39
Study Start Date: December 2000
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042224

Locations
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)
Investigators
Principal Investigator: Georgios Petrides, MD New Jersey Medical School
  More Information

Responsible Party: George Petrides, Associate Professor of Psychiatry, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00042224     History of Changes
Other Study ID Numbers: R01MH060390  DSIR AT-SO 
Study First Received: July 24, 2002
Results First Received: April 9, 2015
Last Updated: September 15, 2015
Health Authority: United States: Federal Government

Keywords provided by Northwell Health:
Electroconvulsive Therapy

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 28, 2016