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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Procedure: Electroconvulsive Therapy (ECT); Drug: Clozapine

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Glen Oaks, New York, United States, 11004
      • Zucker Hillside Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Clozaril
Active Comparator: 2 Clozapine; Clozapine for 8 weeks	Drug: Clozapine; Patients with psychotic symptoms will receive clozapine; Other Names: Clozaril

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.	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.	8 Weeks

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Georgios Petrides, MD, New Jersey Medical School

Study record dates

Study Major Dates

• Study Start: December 1, 2000
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: July 24, 2002
• First Submitted That Met QC Criteria: July 25, 2002
• First Posted (Estimate): July 26, 2002

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Electroconvulsive Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; GABA Agents; GABA Antagonists; Clozapine
• Other Study ID Numbers: R01MH060390 (U.S. NIH Grant/Contract); DSIR AT-SO (NorthShore LIJ Health System)