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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00753051
First Posted: September 16, 2008
Last Update Posted: May 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Suchat Paholpak, Khon Kaen University
  Purpose
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.

Condition Intervention
Schizophrenia Drug: clozapine+haloperidol Drug: clozapine,electroconvulsive therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Clozapine-resistant Schizophrenia : Comparison Between Augmentation With Haloperidol and Electroconvulsive Therapy

Resource links provided by NLM:


Further study details as provided by Suchat Paholpak, Khon Kaen University:

Primary Outcome Measures:
  • PANSS , HAM-D , CGI , AIMS Scores [ Time Frame: every 4 weeks for 24 weeks ]

Enrollment: 18
Study Start Date: June 2008
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: clopaze , Thymatron ECT machine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753051


Locations
Thailand
Department of Psychiatry.Faculty of Medicine.KhonKaen University.
Muang, KhonKaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Suchat Paholpak, MD Department of Psychiatry.Faculty of Medicine.Khon Kaen University
  More Information

Responsible Party: Suchat Paholpak, Professor Doctor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT00753051     History of Changes
Other Study ID Numbers: HE501122
First Submitted: September 15, 2008
First Posted: September 16, 2008
Last Update Posted: May 7, 2012
Last Verified: May 2012

Keywords provided by Suchat Paholpak, Khon Kaen University:
clozapine-resistant schizophrenics
haloperidol augmenting clozapine
electroconvulsive therapy augmenting clozapine

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Haloperidol
Haloperidol decanoate
Clozapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Serotonin Antagonists
Serotonin Agents
GABA Antagonists
GABA Agents