Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

NCT00042224 | Completed Phase 1 Results DMC

• 2 other identifiers: R01MH060390DSIR AT-SO
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

Electroconvulsive Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1 ECT plus clozapine

EXPERIMENTAL

Electroconvulsive therapy ECT plus clozapine for 8 weeks

Procedure: Electroconvulsive Therapy (ECT); Drug: Clozapine

2 Clozapine

ACTIVE COMPARATOR

Clozapine for 8 weeks

Drug: Clozapine

Interventions

Electroconvulsive Therapy (ECT) PROCEDURE

ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.

1 ECT plus clozapine

Clozapine DRUG

Patients with psychotic symptoms will receive clozapine

Also known as: Clozaril

1 ECT plus clozapine; 2 Clozapine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Electroconvulsive Therapy; Clozapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Georgios Petrides, M.D.
• Organization: Northshore LIJ Health System

GPetride@NSHS.EDU

718-470-8569

Study Officials

• Georgios Petrides, MD

  New Jersey Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: July 24, 2002
• First Posted: July 26, 2002
• Study Start: December 1, 2000
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: May 15, 2017
• Results First Posted: October 15, 2015

Record last verified: 2017-04

Locations

US (1)