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

Purpose

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

Condition	Intervention	Phase
Schizophrenia	Procedure: Electroconvulsive Therapy (ECT) Drug: Clozapine	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	ECT in Clozapine Refractory Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Clozapine

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):


Estimated Enrollment:	64
Study Start Date:	December 2000

Arms	Assigned Interventions
Experimental: 1 Electroconvulsive therapy with medication	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
Active Comparator: 2 Medication monotherapy	Drug: Clozapine Patients with psychotic symptoms will receive clozapine Other Name: Clozaril

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.

Eligibility


Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042224

Locations


United States, New York
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Georgios Petrides, MD	New Jersey Medical School

More Information

No publications provided


Responsible Party:	Georgios Petrides, MD, New Jersey Medical School
ClinicalTrials.gov Identifier:	NCT00042224 History of Changes
Other Study ID Numbers:	R01 MH60390, DSIR AT-SO
Study First Received:	July 24, 2002
Last Updated:	October 5, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):


Electroconvulsive Therapy

Additional relevant MeSH terms:


Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features Clozapine Antipsychotic Agents Central Nervous System Agents Central Nervous System Depressants GABA Agents GABA Antagonists	Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Serotonin Agents Serotonin Antagonists Therapeutic Uses Tranquilizing Agents

ClinicalTrials.gov processed this record on March 03, 2015

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