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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Suchat Paholpak, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00753051
First received: September 15, 2008
Last updated: May 4, 2012
Last verified: May 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Khon Kaen University:

Primary Outcome Measures:
  • PANSS , HAM-D , CGI , AIMS Scores [ Time Frame: every 4 weeks for 24 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Suchat Paholpak, Professor Doctor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT00753051     History of Changes
Other Study ID Numbers: HE501122
Study First Received: September 15, 2008
Last Updated: May 4, 2012
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

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

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

ClinicalTrials.gov processed this record on August 25, 2014