Treat Clozapine ( CLZ )-Resistant Schizophrenia Comparing CLZ + Haloperidol vs. CLZ + Electroconvulsive Therapy (ECT) (TCRS)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
clozapine+haloperidol
clozapine,electroconvulsive therapy
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring clozapine-resistant schizophrenics, haloperidol augmenting clozapine, electroconvulsive therapy augmenting clozapine
Eligibility Criteria
Inclusion Criteria:
- schizophrenic patients diagnosed with schedules for clinical assessment in neuropsychiatry ( SCAN )in accordance with DSM-IV-TR or ICD-10
- Resistant to at least 6 weeks of clozapine treatment in therapeutic dosage
- Voluntary to participate the research protocol expressed by signing informed consent form
Exclusion Criteria:
- Patient does not volunteer himself or herself
- Patient is having epilepsy, DM, cardiac disease, autistic disorder and illiterate
- Patient is deaf, blind , dumb to obstruct good communication
Sites / Locations
- Department of Psychiatry.Faculty of Medicine.KhonKaen University.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1.
2.
Arm Description
clozapine as the main agent and it will be adjuncted by haloperidol
clozapine as the main agent and it will be adjuncted by electroconvulsive therapy
Outcomes
Primary Outcome Measures
PANSS , HAM-D , CGI , AIMS Scores
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00753051
Brief Title
Treat Clozapine ( CLZ )-Resistant Schizophrenia Comparing CLZ + Haloperidol vs. CLZ + Electroconvulsive Therapy (ECT)
Acronym
TCRS
Official Title
Treatment of Clozapine-resistant Schizophrenia : Comparison Between Augmentation With Haloperidol and Electroconvulsive Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clozapine treatment resistant schizophrenia is still prevalent.The effectiveness of augmenting clozapine : one augmenting with haloperidol and the other with electroconvulsive therapy should be determined.This study is a randomized control trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
clozapine-resistant schizophrenics, haloperidol augmenting clozapine, electroconvulsive therapy augmenting clozapine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1.
Arm Type
Active Comparator
Arm Description
clozapine as the main agent and it will be adjuncted by haloperidol
Arm Title
2.
Arm Type
Active Comparator
Arm Description
clozapine as the main agent and it will be adjuncted by electroconvulsive therapy
Intervention Type
Drug
Intervention Name(s)
clozapine+haloperidol
Other Intervention Name(s)
clopaze, haloperidol
Intervention Description
clozapine 300-900 mg/d haloperidol 4-60 mg/d
Intervention Type
Drug
Intervention Name(s)
clozapine,electroconvulsive therapy
Other Intervention Name(s)
clopaze , Thymatron ECT machine
Intervention Description
clozapine 300-900 mg/d electroconvulsive therapy 4-12 times
Primary Outcome Measure Information:
Title
PANSS , HAM-D , CGI , AIMS Scores
Time Frame
every 4 weeks for 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
schizophrenic patients diagnosed with schedules for clinical assessment in neuropsychiatry ( SCAN )in accordance with DSM-IV-TR or ICD-10
Resistant to at least 6 weeks of clozapine treatment in therapeutic dosage
Voluntary to participate the research protocol expressed by signing informed consent form
Exclusion Criteria:
Patient does not volunteer himself or herself
Patient is having epilepsy, DM, cardiac disease, autistic disorder and illiterate
Patient is deaf, blind , dumb to obstruct good communication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suchat Paholpak, MD
Organizational Affiliation
Department of Psychiatry.Faculty of Medicine.Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry.Faculty of Medicine.KhonKaen University.
City
Muang
State/Province
KhonKaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
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Treat Clozapine ( CLZ )-Resistant Schizophrenia Comparing CLZ + Haloperidol vs. CLZ + Electroconvulsive Therapy (ECT)
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