Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2005 by National Institute of Mental Health (NIMH).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Institute of Mental Health (NIMH)

ClinicalTrials.gov Identifier:

NCT00042224

First received: July 24, 2002

Last updated: October 5, 2010

Last verified: December 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

July 24, 2002

Last Updated Date

October 5, 2010

Start Date ^ICMJE

December 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00042224 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

Official Title ^ICMJE

ECT in Clozapine Refractory Schizophrenia

Brief Summary

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

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

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 Name: Clozaril

Study Arm (s)

Experimental: 1 Electroconvulsive therapy with medication
Interventions:
- Procedure: Electroconvulsive Therapy (ECT)
- Drug: Clozapine
Active Comparator: 2 Medication monotherapy
Intervention: Drug: Clozapine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00042224

Other Study ID Numbers ^ICMJE

R01 MH60390, DSIR AT-SO

Has Data Monitoring Committee

Not Provided

Responsible Party

Georgios Petrides, MD, New Jersey Medical School

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Georgios Petrides, MD

New Jersey Medical School

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

December 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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