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

July 24, 2002
October 5, 2010
December 2000
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Complete list of historical versions of study NCT00042224 on ClinicalTrials.gov Archive Site
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Electroconvulsive Therapy in Clozapine Refractory Schizophrenia
ECT in Clozapine Refractory Schizophrenia

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

ECT augmentation of clozapine will be compared to clozapine monotherapy in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
  • 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
  • Experimental: 1 Electroconvulsive therapy with medication
    Interventions:
    • Procedure: Electroconvulsive Therapy (ECT)
    • Drug: Clozapine
  • Active Comparator: 2 Medication monotherapy
    Intervention: Drug: Clozapine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
64
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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)
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00042224
R01 MH60390, DSIR AT-SO
Not Provided
Georgios Petrides, MD, New Jersey Medical School
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Georgios Petrides, MD New Jersey Medical School
National Institute of Mental Health (NIMH)
December 2005

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