Trial · NCT06062953
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
NCT06062953, Phase 2, Phase 3, Recruiting, Lone Baandrup
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia. Trials, record NCT06062953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06062953
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
- NCT number
- NCT06062953
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 255 participants, estimated
- Lead sponsor
- Lone Baandrup
- Conditions
- Psychiatric Disorders, Insomnia
- Interventions
- Melatonin, Quetiapine, Placebo
- First posted
- 2023-10-02
- Last updated
- 2025-04-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Insomnia severity | 6 weeks | Insomnia Severity Index, range 0-28, higher is worse |
| Secondary | Clinical global impression (CGI) | 6 weeks | Clinical global impression: Severity, range 0-7, higher is worse |
| Secondary | Subjective sleep quality | 6 weeks | Pittsburgh Sleep Quality Index, range 0-21, higher is worse |
| Secondary | Psychosocial functioning | 6 weeks | Personal and Social Performance Scale, range 1-100, higher is better |
| Secondary | Patient-reported subjective well-being | 6 weeks | WHO-5 well-being index, range 0-100, higher is better |
| Other | Objective sleep quality (polysomnography) | 6 weeks | Total sleep time in minutes, higher is better |
| Other | Circadian rhythmicity (actigraphy) | 6 weeks | Interdaily stability which quantifies the invariability from day to day, i.e., the predictability of the 24 h rest-activity pattern. This index will be 1 for perfect interdaily stability and thus lower values reflect higher variability between the observed days |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06062953
GET https://conductscience.org/api/trials/v1/NCT06062953/registered