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

Schizophrenia Clinical Trial

— TCRS  

Official title:

Treatment of Clozapine-resistant Schizophrenia : Comparison Between Augmentation With Haloperidol and Electroconvulsive Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753051
• Other study ID #: HE501122
• Status: Completed
• Phase: N/A
• First received: September 15, 2008
• Last updated: May 4, 2012
• Start date: June 2008
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• clozapine+haloperidol
clozapine 300-900 mg/d haloperidol 4-60 mg/d
• clozapine,electroconvulsive therapy
clozapine 300-900 mg/d electroconvulsive therapy 4-12 times

Locations

Country	Name	City	State
Thailand	Department of Psychiatry.Faculty of Medicine.KhonKaen University.	Muang	KhonKaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PANSS , HAM-D , CGI , AIMS Scores		every 4 weeks for 24 weeks	No