DeliriumPhase 3QHdeliriumNCT00954603
A Double-blind, Randomized, Controlled Trial of Quetiapine Versus Haloperidol for the Treatment of Delirium
A Phase 3 study testing quetiapine and haloperidol in people with Delirium, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether quetiapine, and haloperidol are effective and safe in the treatment psychiatric symptoms in patients with delirium. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Delirium
- What is being tested?
- quetiapine and haloperidol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2009to Jul 2012
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 18 -75 years
- Was admitted in Maharaj Nakhon Chiang Mai hospital
- Was diagnosed by the diagnostic criteria for DSM-IV-TR delirium due to a general medical condition or delirium due to multiple etiologies
- Delirious state (delirium) of the patients was confirmed by using name-assess confusion assessment method (CAM) and assessment of severity with delirium rating scale-revised-98 (DRS-R-98)
- Have a written consent from the legal representatives
Who cannot join
- Was diagnosed substance withdrawal delirium
- Having a history drug allergy either from quetiapine or haloperidol
- Female patients who are pregnant or breastfeeding
- No written consent from the legal representatives
- Received other anti-psychotic drug before attend the study
- Being ill with renal or hepatic failure
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of psychiatry, faculty of medicine, Chiang Mai university
Chiang Mai, 50200
About this study
Official title: Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium
The purpose of this study is to determine whether quetiapine, and haloperidol are effective and safe in the treatment psychiatric symptoms in patients with delirium.
Read the detailed description
A delirious state often founds in general hospitals and remains a significant cause of death. Existing methods of treatment includes identification and elimination of factors contributing to the delirium in addition to pharmacological and nonpharmacological treatment interventions (Trzepacz et al., 1999). Antipsychotics can play an important role in the management of the symptoms of delirium.
- Conditions
- Delirium
- Being tested
- quetiapine, haloperidol
- Keywords
- delirium rating scale, clinical global improvement, extrapyramidal side effect
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapineDrug
Also called seroquel
25-100 mg
haloperidolDrug
Also called haldol
0.5-2 mg
| Study group | Role | What they receive |
|---|---|---|
| quetiapine | Experimental | atypical antipsychotic drug Receives: Drug: quetiapine |
| haloperidol | Active comparator | typical antipsychotic drug Receives: Drug: haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in delirium rating scale and clinical global improvement
Measured: 7 days
Secondary outcomes (1)
compare extrapyramidal and other report side effects of quetiapine and haloperidol from modified Simpson Angus scale and other report side effects.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2011
- Study completionJul 2012 (estimated)
Why it stopped: few delirious patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Investigators
- Benchalak Maneeton, Assoc Prof, Principal investigator, Department of Psychiatry,Faculty of Medicine, Chiang Mai university, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954603
- Sponsor's protocol ID
- MedCMU Que vs Halo - 2008
- Other IDs
- Que vs Halo - 2008
- Acronym
- QHdelirium
- Status last verified
- Aug 2009
- First submitted
- 6 Aug 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maneeton B, Maneeton N, Srisurapanont M. An open-label study of quetiapine for delirium. J Med Assoc Thai. 2007 Oct;90(10):2158-63.
PubMed 18041437Maneeton B, Maneeton N, Srisurapanont M, Chittawatanarat K. Quetiapine versus haloperidol in the treatment of delirium: a double-blind, randomized, controlled trial. Drug Des Devel Ther. 2013 Jul 24;7:657-67. doi: 10.2147/DDDT.S45575. Print 2013.
PubMed 23926422
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium
- ClinicalTrials.gov ID
- NCT00954603
- Acronym / sponsor ID
- QHdelirium / MedCMU Que vs Halo - 2008
- Conditions
- Delirium
- Keywords
- delirium rating scale, clinical global improvement, extrapyramidal side effect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: few delirious patients were enrolled.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jul 2012 (estimated)
- First posted
- 7 Aug 2009 (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.
The purpose of this study is to determine whether quetiapine, and haloperidol are effective and safe in the treatment psychiatric symptoms in patients with delirium.
Detailed description
A delirious state often founds in general hospitals and remains a significant cause of death. Existing methods of treatment includes identification and elimination of factors contributing to the delirium in addition to pharmacological and nonpharmacological treatment interventions (Trzepacz et al., 1999). Antipsychotics can play an important role in the management of the symptoms of delirium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| quetiapine | Experimental | Drug: quetiapineatypical antipsychotic drug |
| haloperidol | Active comparator | Drug: haloperidoltypical antipsychotic drug |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female age 18 -75 years
- Was admitted in Maharaj Nakhon Chiang Mai hospital
- Was diagnosed by the diagnostic criteria for DSM-IV-TR delirium due to a general medical condition or delirium due to multiple etiologies
- Delirious state (delirium) of the patients was confirmed by using name-assess confusion assessment method (CAM) and assessment of severity with delirium rating scale-revised-98 (DRS-R-98)
- Have a written consent from the legal representatives
Key exclusion criteria (6 listed)
- Was diagnosed substance withdrawal delirium
- Having a history drug allergy either from quetiapine or haloperidol
- Female patients who are pregnant or breastfeeding
- No written consent from the legal representatives
- Received other anti-psychotic drug before attend the study
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 |
|---|---|---|
| quetiapineAlso: seroquel25-100 mg | Drug | quetiapine |
| haloperidolAlso: haldol0.5-2 mg | Drug | haloperidol |
Primary outcome
decrease in delirium rating scale and clinical global improvement
Time frame: 7 days
1 secondary outcome
compare extrapyramidal and other report side effects of quetiapine and haloperidol from modified Simpson Angus scale and other report side effects.
Time frame: 7 days
Results and safety
The study was stopped early (reason given: few delirious patients were enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- Results publication: PubMed 18041437Maneeton B, Maneeton N, Srisurapanont M. An open-label study of quetiapine for delirium. J Med Assoc Thai. 2007 Oct;90(10):2158-63.
- Derived from this study: PubMed 23926422Maneeton B, Maneeton N, Srisurapanont M, Chittawatanarat K. Quetiapine versus haloperidol in the treatment of delirium: a double-blind, randomized, controlled trial. Drug Des Devel Ther. 2013 Jul 24;7:657-67. doi: 10.2147/DDDT.S45575. Print 2013.
- treatment deliriumLink provided by the sponsor.
- treatment deliriumLink provided by the sponsor.
- treatment deliriumLink provided by the sponsor.
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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.
Benchalak Maneeton, Assoc Prof principal investigator
Department of Psychiatry,Faculty of Medicine, Chiang Mai university, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing quetiapine and haloperidol in people with Delirium, run by Chiang Mai 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 23 Jun 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: few delirious patients were enrolled.). Results are not available in the source record.
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?
decrease in delirium rating scale and clinical global improvement (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00954603, which also lists 2 linked publications.
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 23 Jun 2011.