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

NCT ID: NCT00753051

Last Updated: 2012-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2012-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1.

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

Group Type: ACTIVE_COMPARATOR

clozapine+haloperidol

Intervention Type: DRUG

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

2.

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

Group Type: ACTIVE_COMPARATOR

clozapine,electroconvulsive therapy

Intervention Type: DRUG

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

Interventions

clozapine+haloperidol

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

Intervention Type: DRUG

clozapine,electroconvulsive therapy

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

Intervention Type: DRUG

Other Intervention Names

clopaze, haloperidol; clopaze , Thymatron ECT machine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Suchat Paholpak

Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suchat Paholpak, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry.Faculty of Medicine.Khon Kaen University

Locations

Department of Psychiatry.Faculty of Medicine.KhonKaen University.

Muang, KhonKaen, Thailand

Countries

Thailand

Other Identifiers

HE501122

Identifier Type: -

Identifier Source: org_study_id