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Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Electroconvulsive Therapy (ECT)
Clozapine
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Electroconvulsive Therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Diagnosis of schizophrenia according to DSM-IV criteria Duration of illness 2 years or greater Resistance to at least 2 antipsychotics Clozapine resistance Capacity to give informed consent For women of childbearing capacity, a negative pregnancy test and patient agreement to use a medically accepted form of contraception Brief Psychiatric Rating Scale score of at least a 4 on one of the four psychotic items on the psychotic sub-scale or a score of 12 on these 4 items combined. Clinical Global Impressions (CGI) - severity rating of at least moderate (score of 4) 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) Exclusion criteria schizoaffective disorder; bipolar disorder; current affective episode; Electroconvulsive Therapy (ECT) within the past 6 months history of epilepsy; severe neurological or systemic disorder that could significantly affect cognition, behavior, or mental status (other than tardive dyskinesia or neuroleptic-induced parkinsonism); psychoactive substance dependence (other than nicotine or caffeine) within 1 month prior to entering the study a score of less than 18 on the 24-item Hamilton Depression Rating Scale (HAM-D) clinical determination that mood stabilizers were necessary and therefore could not be discontinued. pregnancy. affective disorders and prominent depressive symptoms because ECT is well known to be effective in those situations, and we wanted to avoid contamination of our results by improvement solely driven by the treatment of the affective symptoms.

Sites / Locations

  • Zucker Hillside Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 ECT plus clozapine

2 Clozapine

Arm Description

Electroconvulsive therapy ECT plus clozapine for 8 weeks

Clozapine for 8 weeks

Outcomes

Primary Outcome Measures

Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.
Response is defined as 40% reduction of symptoms in the psychotic symptom sub-scale (hallucinatory behavior, suspiciousness, conceptual disorganization, and unusual thought of content) of the Brief Psychiatric Rating Scale (BPRS) at the end of the 8-week study. BPRS assesses psychotic symptoms on a 18-item scale. The severity of each item is rated on a continuous scale from 1-7, with 1 being the least severe and 7 being most severe. Participants included in the study, at baseline had at least a moderate score of 4 on one of the four psychotic symptom sub-scale or a score of 12 on all four of these items combined (ranges 4 -28, with higher scores indicative of greater severity). A reduction of symptoms would be a sub-scale score which is 40% less than participants baseline score. If a participant enters the study with a sub-scale score of 15, to be considered a responder (at least a 40% reduction in symptoms score) his/her score must decrease by at least 6 points and be 9 or less.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2002
Last Updated
April 10, 2017
Sponsor
Northwell Health
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00042224
Brief Title
Electroconvulsive Therapy in Clozapine Refractory Schizophrenia
Official Title
ECT in Clozapine Refractory Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Electroconvulsive Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 ECT plus clozapine
Arm Type
Experimental
Arm Description
Electroconvulsive therapy ECT plus clozapine for 8 weeks
Arm Title
2 Clozapine
Arm Type
Active Comparator
Arm Description
Clozapine for 8 weeks
Intervention Type
Procedure
Intervention Name(s)
Electroconvulsive Therapy (ECT)
Intervention Description
ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
Intervention Type
Drug
Intervention Name(s)
Clozapine
Other Intervention Name(s)
Clozaril
Intervention Description
Patients with psychotic symptoms will receive clozapine
Primary Outcome Measure Information:
Title
Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.
Description
Response is defined as 40% reduction of symptoms in the psychotic symptom sub-scale (hallucinatory behavior, suspiciousness, conceptual disorganization, and unusual thought of content) of the Brief Psychiatric Rating Scale (BPRS) at the end of the 8-week study. BPRS assesses psychotic symptoms on a 18-item scale. The severity of each item is rated on a continuous scale from 1-7, with 1 being the least severe and 7 being most severe. Participants included in the study, at baseline had at least a moderate score of 4 on one of the four psychotic symptom sub-scale or a score of 12 on all four of these items combined (ranges 4 -28, with higher scores indicative of greater severity). A reduction of symptoms would be a sub-scale score which is 40% less than participants baseline score. If a participant enters the study with a sub-scale score of 15, to be considered a responder (at least a 40% reduction in symptoms score) his/her score must decrease by at least 6 points and be 9 or less.
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Diagnosis of schizophrenia according to DSM-IV criteria Duration of illness 2 years or greater Resistance to at least 2 antipsychotics Clozapine resistance Capacity to give informed consent For women of childbearing capacity, a negative pregnancy test and patient agreement to use a medically accepted form of contraception Brief Psychiatric Rating Scale score of at least a 4 on one of the four psychotic items on the psychotic sub-scale or a score of 12 on these 4 items combined. Clinical Global Impressions (CGI) - severity rating of at least moderate (score of 4) 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) Exclusion criteria schizoaffective disorder; bipolar disorder; current affective episode; Electroconvulsive Therapy (ECT) within the past 6 months history of epilepsy; severe neurological or systemic disorder that could significantly affect cognition, behavior, or mental status (other than tardive dyskinesia or neuroleptic-induced parkinsonism); psychoactive substance dependence (other than nicotine or caffeine) within 1 month prior to entering the study a score of less than 18 on the 24-item Hamilton Depression Rating Scale (HAM-D) clinical determination that mood stabilizers were necessary and therefore could not be discontinued. pregnancy. affective disorders and prominent depressive symptoms because ECT is well known to be effective in those situations, and we wanted to avoid contamination of our results by improvement solely driven by the treatment of the affective symptoms.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgios Petrides, MD
Organizational Affiliation
New Jersey Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States

12. IPD Sharing Statement

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Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

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