Primary InsomniaNCT00328822
Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial
A study testing Quetiapine in people with Primary Insomnia, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Primary insomnia patients will sleep with Quetiapine not better than without Quetiapine Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Quetiapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2006to Aug 2007
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary insomnia Patients by DSM-IV-TR criteria
- cases enrolled: age 18-65 educated
Who cannot join
- Currently receiving Quetiapine or other hypnotic drugs
- Liver disease
- Patients with heart Dz, Hypertension, thyroid disease
- History of epilepsy or febrile convulsion
- pregnant
- cognitive impairments
- History of Orthostatic Hypotension
- Patient with other Psychiatric conditions or Drug dependence
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Srinagarind Hospital, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002
About this study
Primary insomnia patients will sleep with Quetiapine not better than without Quetiapine
Read the detailed description
- Primary insomnia will be diagnosed according to DSM-IV-TR
- After consenting, cases will be divided (double blind randomization)in to two arms 2.1 sleep hygiene with placebo group 2.2 sleep hygiene with Quetiapine group
- outcome measurement: sleep diary, sleep satisfaction visual analog scale and sleep satisfaction likert scale
- statistical method: dependent T test
- Conditions
- Primary Insomnia
- Being tested
- Quetiapine, placebo
- Keywords
- Primary insomnia, Quetiapine, Randomized controlled trial, Double blind
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Quetiapine Receives: Drug: Quetiapine |
| B | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
Measured: 3 weeks
Secondary outcomes (1)
Sleep Latency Period, Sleep satisfaction
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startDec 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary InsomniaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Investigators
- Kanida Tassniyom, MD, Principal investigator, Department of Psychiatry, Faculty of Medicine, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328822
- Sponsor's protocol ID
- HE490424
- Status last verified
- Oct 2006
- First submitted
- 19 May 2006
- Last updated
- 18 Mar 2008
- Results posted
- No
Publications
Tassniyom K, Paholpak S, Tassniyom S, Kiewyoo J. Quetiapine for primary insomnia: a double blind, randomized controlled trial. J Med Assoc Thai. 2010 Jun;93(6):729-34.
PubMed 20572379
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00328822
- Acronym / sponsor ID
- HE490424
- Conditions
- Primary Insomnia
- Keywords
- Primary insomnia, Quetiapine, Randomized controlled trial, Double blind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Dec 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 22 May 2006 (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.
Primary insomnia patients will sleep with Quetiapine not better than without Quetiapine
Detailed description
- Primary insomnia will be diagnosed according to DSM-IV-TR
- After consenting, cases will be divided (double blind randomization)in to two arms 2.1 sleep hygiene with placebo group 2.2 sleep hygiene with Quetiapine group
- outcome measurement: sleep diary, sleep satisfaction visual analog scale and sleep satisfaction likert scale
- statistical method: dependent T test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: QuetiapineQuetiapine |
| B | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary insomnia Patients by DSM-IV-TR criteria
- cases enrolled: age 18-65 educated
Key exclusion criteria (8 listed)
- Currently receiving Quetiapine or other hypnotic drugs
- Liver disease
- Patients with heart Dz, Hypertension, thyroid disease
- History of epilepsy or febrile convulsion
- pregnant
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 |
|---|---|---|
| Quetiapine | Drug | A |
| placebo | Drug | B |
Primary outcome
Total Sleep Time
Time frame: 3 weeks
1 secondary outcome
Sleep Latency Period, Sleep satisfaction
Time frame: 3 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 18 Mar 2008.
- Derived from this study: PubMed 20572379Tassniyom K, Paholpak S, Tassniyom S, Kiewyoo J. Quetiapine for primary insomnia: a double blind, randomized controlled trial. J Med Assoc Thai. 2010 Jun;93(6):729-34.
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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.
Kanida Tassniyom, 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 Quetiapine in people with Primary Insomnia, 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 2 inclusion and 8 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 18 Mar 2008. 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. Some participants in this study may receive a placebo. 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?
Total Sleep Time (time frame: 3 weeks). 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 NCT00328822, which also lists 1 linked publication.
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 18 Mar 2008.