Treat Clozapine ( CLZ )-Resistant Schizophrenia Comparing CLZ + Haloperidol vs. CLZ + Electroconvulsive Therapy (ECT) (TCRS)
This study has been completed.
Sponsor:
Khon Kaen University
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- 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
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 May 22, 2013