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

NCT00753051 | Completed

• 1 other identifier: HE501122
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Keywords

clozapine-resistant schizophrenics; haloperidol augmenting clozapine; electroconvulsive therapy augmenting clozapine

Outcome Measures

Primary Outcomes (1)

• PANSS , HAM-D , CGI , AIMS Scores

  every 4 weeks for 24 weeks

Study Arms (2)

1.

ACTIVE COMPARATOR

clozapine as the main agent and it will be adjuncted by haloperidol

Drug: clozapine+haloperidol

2.

ACTIVE COMPARATOR

clozapine as the main agent and it will be adjuncted by electroconvulsive therapy

Drug: clozapine,electroconvulsive therapy

Interventions

clozapine+haloperidol DRUG

clozapine 300-900 mg/d haloperidol 4-60 mg/d

Also known as: clopaze, haloperidol

1.

clozapine,electroconvulsive therapy DRUG

clozapine 300-900 mg/d electroconvulsive therapy 4-12 times

Also known as: clopaze , Thymatron ECT machine

2.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Department of Psychiatry.Faculty of Medicine.KhonKaen University.

Muang, KhonKaen, 40002, Thailand

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Haloperidol; Clozapine; Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Suchat Paholpak, MD

  Department of Psychiatry.Faculty of Medicine.Khon Kaen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 16, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

TH (1)