Treat Clozapine ( CLZ )-Resistant Schizophrenia Comparing CLZ + Haloperidol vs. CLZ + Electroconvulsive Therapy (ECT) (TCRS)

May 4, 2012 updated by: Suchat Paholpak, Khon Kaen University

Treatment of Clozapine-resistant Schizophrenia : Comparison Between Augmentation With Haloperidol and Electroconvulsive Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • KhonKaen
      • Muang, KhonKaen, Thailand, 40002
        • Department of Psychiatry.Faculty of Medicine.KhonKaen University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1.
clozapine as the main agent and it will be adjuncted by haloperidol
Drug: clozapine+haloperidol
clozapine 300-900 mg/d haloperidol 4-60 mg/d
Other Names:
  • clopaze, haloperidol
Active Comparator: 2.
clozapine as the main agent and it will be adjuncted by electroconvulsive therapy
Drug: clozapine,electroconvulsive therapy
clozapine 300-900 mg/d electroconvulsive therapy 4-12 times
Other Names:
  • clopaze , Thymatron ECT machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PANSS , HAM-D , CGI , AIMS Scores
Time Frame: every 4 weeks for 24 weeks
every 4 weeks for 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Suchat Paholpak, MD, Department of Psychiatry.Faculty of Medicine.Khon Kaen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

September 15, 2008

First Submitted That Met QC Criteria

September 15, 2008

First Posted (Estimate)

September 16, 2008

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE501122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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