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
  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:


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
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 October 21, 2014