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Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
George Petrides, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00042224
First received: July 24, 2002
Last updated: September 15, 2015
Last verified: September 2015
Results First Received: April 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Procedure: Electroconvulsive Therapy (ECT)
Drug: Clozapine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
participants were recruited from the inpatient units of the Zucker Hillside Hospital at Glen Oaks, N.Y., and the Pilgrim State Psychiatric Center in Long Island, N.Y.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In an 8-week random-assignment study incorporating nonblinded treatment and blinded assessments, patients with antipsychotic and clozapine-resistant schizophrenia were assigned to two treatment groups.

Reporting Groups
  Description
1 Electroconvulsive Therapy With Medication

Electroconvulsive Therapy (ECT): ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.

Clozapine: Patients with psychotic symptoms will receive clozapine

2 Medication Monotherapy Clozapine: Patients with psychotic symptoms will receive clozapine

Participant Flow:   Overall Study
    1 Electroconvulsive Therapy With Medication   2 Medication Monotherapy
STARTED   20   19 
COMPLETED   17   16 
NOT COMPLETED   3   3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Electroconvulsive Therapy With Medication

Procedure/Surgery: 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 Names:

• Clozaril

Medication Monotherapy

Drug: Clozapine Patients with psychotic symptoms will receive clozapine

Other Names:

• Clozaril

Total Total of all reporting groups

Baseline Measures
   Electroconvulsive Therapy With Medication   Medication Monotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   19   39 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   20   19   39 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.70  (2.27)   42.78  (1.82)   39.24  (2.05) 
Gender 
[Units: Participants]
     
Female   5   13   18 
Male   15   6   21 
Region of Enrollment 
[Units: Participants]
     
United States   20   19   39 


  Outcome Measures

1.  Primary:   Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.   [ Time Frame: 8 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Georgios Petrides, M.D.
Organization: Northshore LIJ Health System
phone: 718-470-8569
e-mail: GPetride@NSHS.EDU



Responsible Party: George Petrides, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00042224     History of Changes
Other Study ID Numbers: R01MH060390 ( US NIH Grant/Contract Award Number )
DSIR AT-SO ( Other Identifier: NorthShore LIJ Health System )
Study First Received: July 24, 2002
Results First Received: April 9, 2015
Last Updated: September 15, 2015
Health Authority: United States: Federal Government