Psychiatric DisordersPhase 2/3MEL-QUENCT06062953
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
A Phase 2/3 study testing Melatonin and Quetiapine in people with Psychiatric Disorders and Insomnia, run by Lone Baandrup at 1 site in Denmark.
Trial summary
The goal of this investigator-initiated, randomized, blinded, 3-armed placebo-controlled, pragmatic, clinical superiority trial is to examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia in patients with psychiatric disorders. Read more about this study
- Who is it for?
- Ages 16 to 64 years
- Conditions the study is for
- Psychiatric Disorders, Insomnia
- What is being tested?
- Melatonin and Quetiapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Sep 2023to 28 Feb 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 16 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 16 to 64 years of age
- ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-95)
- For the diagnoses F84 and F90 a previous period of treatment with melatonin is required
- For the 16-17 years old: Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect
- Self-reported sleep difficulties at least three times per week in the preceding 3 months
- Insomnia Severity Index score ≥11
- Women of childbearing potential: negative pregnancy test at baseline and use of highly effective contraception measures
- Informed consent
Who cannot join
- Current treatment with melatonin or quetiapine
- Severe somatic comorbidity
- BMI ≥ 35 kg/m2
- Breastfeeding
- Alcohol and/or substance dependency within the last 3 months
- Inadequate Danish language skills
- Not able to make an informed consent
- Increased cardiac risk as assessed by presence of cardiac risk factors, cardiac symptoms, or prolonged QT-interval at baseline ECG
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Mental Health Center Copenhagen
Copenhagen NV, 2400
Ursula Brinck-Claussen, MD, +4520483136, ursula.oedum.brinck-claussen@regionh.dk
About this study
Official title: Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial
The goal of this investigator-initiated, randomized, blinded, 3-armed placebo-controlled, pragmatic, clinical superiority trial is to examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia in patients with psychiatric disorders. The aims of the study are:
- To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia
- To examine how melatonin or low-dose quetiapine affects global symptom severity, sleep quality, psychosocial functioning and subjective well-being.
Participants will receive six weeks of treatment with either melatonin, quetiapine or placebo followed by a brief taper off.
- Conditions
- Psychiatric Disorders, Insomnia
- Being tested
- Melatonin, Quetiapine, Placebo
- Medical subject headings
- Mental Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
3-9 mg flexible dosing before bed time
QuetiapineDrug
50-150 mg flexible dosing before bed time
PlaceboDrug
1-3 capsules flexible dosing before bed time
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Not described Receives: Drug: Melatonin |
| Quetiapine | Experimental | Not described Receives: Drug: Quetiapine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity
Insomnia Severity Index, range 0-28, higher is worse
Measured: 6 weeks
Secondary outcomes (4)
Clinical global impression (CGI)
Clinical global impression: Severity, range 0-7, higher is worse
Measured: 6 weeks
Subjective sleep quality
Pittsburgh Sleep Quality Index, range 0-21, higher is worse
Measured: 6 weeks
Psychosocial functioning
Personal and Social Performance Scale, range 1-100, higher is better
Measured: 6 weeks
Patient-reported subjective well-being
WHO-5 well-being index, range 0-100, higher is better
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start18 Sep 2023
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisordersStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lone Baandrup
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Center for Sleep Medicine, Region Capital Denmark, Copenhagen Trial Unit, Center for Clinical Intervention Research, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Responsible party
- Sponsor-investigator, Lone Baandrup, University of Copenhagen
- Investigators
- Lone Baandrup, MD, Principal investigator, Mental Health Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062953
- Sponsor's protocol ID
- 2023-504728-24-00
- Other IDs
- 2023
- Acronym
- MEL-QUE
- Status last verified
- Apr 2025
- First submitted
- 13 Sep 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available for meta-analysis. Proposals should be directed to: lone.baandrup@regionh.dk. To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06062953
- Acronym / sponsor ID
- MEL-QUE / 2023-504728-24-00
- Conditions
- Psychiatric Disorders, Insomnia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Lone BaandrupUniversity, hospital or other
- Collaborators
- Danish Center for Sleep Medicine, Region Capital Denmark, Copenhagen Trial Unit, Center for Clinical Intervention Research, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 2 Oct 2023 (actual)
- 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 goal of this investigator-initiated, randomized, blinded, 3-armed placebo-controlled, pragmatic, clinical superiority trial is to examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia in patients with psychiatric disorders. The aims of the study are:
- To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia
- To examine how melatonin or low-dose quetiapine affects global symptom severity, sleep quality, psychosocial functioning and subjective well-being.
Participants will receive six weeks of treatment with either melatonin, quetiapine or placebo followed by a brief taper off.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: Melatonin |
| Quetiapine | Experimental | Drug: Quetiapine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 16 to 64 years of age
- ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-95)
- For the diagnoses F84 and F90 a previous period of treatment with melatonin is required
- For the 16-17 years old: Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect
- Self-reported sleep difficulties at least three times per week in the preceding 3 months
Key exclusion criteria (8 listed)
- Current treatment with melatonin or quetiapine
- Severe somatic comorbidity
- BMI ≥ 35 kg/m2
- Breastfeeding
- Alcohol and/or substance dependency within the last 3 months
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 |
|---|---|---|
| Melatonin3-9 mg flexible dosing before bed time | Drug | Melatonin |
| Quetiapine50-150 mg flexible dosing before bed time | Drug | Quetiapine |
| Placebo1-3 capsules flexible dosing before bed time | Drug | Placebo |
Primary outcome
Insomnia severity
Time frame: 6 weeks
Insomnia Severity Index, range 0-28, higher is worse
4 secondary outcomes
Clinical global impression (CGI)
Time frame: 6 weeks
Subjective sleep quality
Time frame: 6 weeks
Psychosocial functioning
Time frame: 6 weeks
Patient-reported subjective well-being
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: Yes. Individual participant data will be available for meta-analysis. Proposals should be directed to: lone.baandrup@regionh.dk. To gain access, data requestors will need to sign a data access agreement.
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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.
Lone Baandrup, MD principal investigator
Mental Health Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Melatonin and Quetiapine in people with Psychiatric Disorders and Insomnia, run by Lone Baandrup at 1 site in Denmark.
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 8 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: looking for participants now, as of the sponsor's last update on 24 Apr 2025. 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 Denmark. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lone Baandrup, MD (+4591165903, lone.baandrup@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity (time frame: 6 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 24 Apr 2025.