Treat Clozapine-Resistant Schizophrenia Comparing Between Clozapine + Haloperidol Versus Clozapine + Electroconvulsive Therapy (ECT) - Full Text View

Treat Clozapine-Resistant Schizophrenia Comparing Between Clozapine + Haloperidol Versus Clozapine + Electroconvulsive Therapy (ECT) (TCRS)

This study is currently recruiting participants.

Verified by Khon Kaen University, July 2008

First Received: September 15, 2008 No Changes Posted

Sponsored by:	Khon Kaen University
Information provided by:	Khon Kaen University
ClinicalTrials.gov Identifier:	NCT00753051

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Clozapine-Resistant Schizophrenia : Comparison Between Augmentation With Haloperidol and Electroconvulsive Therapy

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Haloperidol Haloperidol decanoate Haloperidol lactate Clozapine

U.S. FDA Resources

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 ]

Estimated Enrollment:	30
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1.: Active Comparator clozapine+haloperidol	Drug: clozapine+haloperidol clozapine 300-900 mg/d haloperidol 4-60 mg/d
2.: Active Comparator clozapine+electroconvulsive therapy	Drug: clozapine,electroconvulsive therapy clozapine 300-900 mg/d electroconvulsive therapy 4-12 times

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753051

Contacts

Contact: Suchat Paholpak, MD

66-81-6610674

suchat_p@kku.ac.th

Locations

Thailand, KhonKaen
Department of Psychiatry.Faculty of Medicine.KhonKaen University.	Recruiting
Muang, KhonKaen, Thailand, 40002
Contact: Suchat Paholpak 66-81-6610674 suchat_p@kku.ac.th
Contact: Suchat Paholpak, MD 66-81-6610674 suchat_p@kku.ac.th
Principal Investigator: Suchat Paholpak, MD

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:	Department of Psychiatry.Faculty of Medicine. Khon Kaen University. ( Prof Dr.Suchat Paholpak )
Study ID Numbers:	HE501122
Study First Received:	September 15, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00753051 History of Changes
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

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Serotonin
Schizophrenia
Haloperidol

Haloperidol decanoate
Dopamine
Mental Disorders
Clozapine
Dopamine Agents
Psychotic Disorders
Peripheral Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Haloperidol
Schizophrenia
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Schizophrenia and Disorders with Psychotic Features
Tranquilizing Agents
Gastrointestinal Agents

Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
GABA Antagonists
Haloperidol decanoate
Serotonin Agents
Autonomic Agents
Clozapine
GABA Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 02, 2009