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

ClinicalTrials.gov processed this record on June 17, 2013