Overview

This trial is active, not recruiting.

Condition schizophrenia
Treatments electroconvulsive therapy (ect), clozapine
Phase phase 1/phase 2
Sponsor National Institute of Mental Health (NIMH)
Start date December 2000
Trial size 64 participants
Trial identifier NCT00042224, DSIR AT-SO, R01 MH60390

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
electroconvulsive therapy (ect)
ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
clozapine Clozaril
Patients with psychotic symptoms will receive clozapine
(Active Comparator)
clozapine Clozaril
Patients with psychotic symptoms will receive clozapine

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion criteria: - 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)

Additional Information

Official title ECT in Clozapine Refractory Schizophrenia
Principal investigator Georgios Petrides, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by National Institute of Mental Health (NIMH).