Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

Northwell Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Clozapine; Procedure: Electroconvulsive Therapy (ECT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00042224

DSIR AT-SO

R01MH060390 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups

1 ECT plus clozapine

Experimental group

Description:

Electroconvulsive therapy ECT plus clozapine for 8 weeks

Treatment:

Procedure: Electroconvulsive Therapy (ECT)

Drug: Clozapine

2 Clozapine

Active Comparator group

Description:

Clozapine for 8 weeks

Treatment:

Drug: Clozapine