Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

Completed · Phase 1/Phase 2

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT00042224

Run by

Northwell Health

People needed

39

Starts

2000-12-01

Expected to finish

2008-07-01

Last updated by the study team

2017-05-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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