SchizophreniaTCRSNCT00753051
Treat Clozapine ( CLZ )-Resistant Schizophrenia Comparing CLZ + Haloperidol vs. CLZ + Electroconvulsive Therapy (ECT)
A study testing clozapine+haloperidol and clozapine,electroconvulsive therapy in people with Schizophrenia, run by Khon Kaen University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- clozapine+haloperidol and clozapine,electroconvulsive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2008to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Psychiatry.Faculty of Medicine.KhonKaen University.
Muang, KhonKaen, 40002
About this study
Official title: Treatment of Clozapine-resistant Schizophrenia : Comparison Between Augmentation With Haloperidol and Electroconvulsive Therapy
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
- Being tested
- clozapine+haloperidol, clozapine,electroconvulsive therapy
- Keywords
- clozapine-resistant schizophrenics, haloperidol augmenting clozapine, electroconvulsive therapy augmenting clozapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clozapine+haloperidolDrug
Also called clopaze, haloperidol
clozapine 300-900 mg/d haloperidol 4-60 mg/d
clozapine,electroconvulsive therapyDrug
Also called clopaze , Thymatron ECT machine
clozapine 300-900 mg/d electroconvulsive therapy 4-12 times
| Study group | Role | What they receive |
|---|---|---|
| 1. | Active comparator | clozapine as the main agent and it will be adjuncted by haloperidol Receives: Drug: clozapine+haloperidol |
| 2. | Active comparator | clozapine as the main agent and it will be adjuncted by electroconvulsive therapy Receives: Drug: clozapine,electroconvulsive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS , HAM-D , CGI , AIMS Scores
Measured: every 4 weeks for 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suchat Paholpak, Khon Kaen University
- Investigators
- Suchat Paholpak, MD, Principal investigator, Department of Psychiatry.Faculty of Medicine.Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753051
- Sponsor's protocol ID
- HE501122
- Acronym
- TCRS
- Status last verified
- May 2012
- First submitted
- 15 Sep 2008
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Clozapine-resistant Schizophrenia : Comparison Between Augmentation With Haloperidol and Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT00753051
- Acronym / sponsor ID
- TCRS / HE501122
- Conditions
- Schizophrenia
- Keywords
- clozapine-resistant schizophrenics, haloperidol augmenting clozapine, electroconvulsive therapy augmenting clozapine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 16 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. | Active comparator | Drug: clozapine+haloperidolclozapine as the main agent and it will be adjuncted by haloperidol |
| 2. | Active comparator | Drug: clozapine,electroconvulsive therapyclozapine as the main agent and it will be adjuncted by electroconvulsive therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clozapine+haloperidolAlso: clopaze, haloperidolclozapine 300-900 mg/d haloperidol 4-60 mg/d | Drug | 1. |
| clozapine,electroconvulsive therapyAlso: clopaze , Thymatron ECT machineclozapine 300-900 mg/d electroconvulsive therapy 4-12 times | Drug | 2. |
Primary outcome
PANSS , HAM-D , CGI , AIMS Scores
Time frame: every 4 weeks for 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suchat Paholpak, MD principal investigator
Department of Psychiatry.Faculty of Medicine.Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clozapine+haloperidol and clozapine,electroconvulsive therapy in people with Schizophrenia, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS , HAM-D , CGI , AIMS Scores (time frame: every 4 weeks for 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012; AzTrials last refreshed its copy on 8 Nov 2026.