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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
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. schizophrenic patients diagnosed with schedules for clinical assessment in neuropsychiatry ( SCAN )in accordance with DSM-IV-TR or ICD-10
  2. Resistant to at least 6 weeks of clozapine treatment in therapeutic dosage
  3. Voluntary to participate the research protocol expressed by signing informed consent form

Exclusion Criteria:

  1. Patient does not volunteer himself or herself
  2. Patient is having epilepsy, DM, cardiac disease, autistic disorder and illiterate
  3. 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

First Posted
September 15, 2008
Last Updated
May 4, 2012
Sponsor
Khon Kaen University
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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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