Electroconvulsive Therapy in Clozapine Refractory Schizophrenia - Full Text View

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 Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Treatment
Official Title:	ECT in Clozapine Refractory Schizophrenia

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Clozapine

U.S. FDA Resources

Further study details as provided by George Petrides, Northwell Health:

Primary Outcome Measures:

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.


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)
Sexes Eligible for Study:	All
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, Northwell Health
ClinicalTrials.gov Identifier:	NCT00042224 History of Changes
Other Study ID Numbers:	R01MH060390 ( US NIH Grant/Contract Award Number ) DSIR AT-SO ( Other Identifier: NorthShore LIJ Health System )
Study First Received:	July 24, 2002
Results First Received:	April 9, 2015
Last Updated:	April 10, 2017

Keywords provided by George Petrides, 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 June 27, 2017