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NCT06062953: MEL-QUE
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
Phase 2, PHASE3 trial testing Melatonin in Psychiatric Disorders in 255 participants. Currently enrolling.
28 February 2029
Quick facts
| Lead sponsor | Lone Baandrup |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 255 |
| Start date | 18 September 2023 |
| Primary completion | 28 February 2029 |
| Estimated completion | 28 February 2029 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Melatonin (MELATONIN) — full drug profile →
- Quetiapine (quetiapine) — full drug profile →
- Placebo
Conditions studied
- Psychiatric Disorders — all drugs for Psychiatric Disorders →
- Insomnia — all drugs for Insomnia →
Sponsor
Lone Baandrup
Who can join
Adults 16 to 64, any sex, with Psychiatric Disorders or Insomnia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06062953
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Melatonin
Trials testing the same drug.
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- NCT07503600 — The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections · Phase 3 · not yet recruiting
- NCT07375342 — Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric · NA · enrolling by invitation
- NCT07305350 — EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES · Phase 2 · active not recruiting
- NCT07096635 — Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction · NA · not yet recruiting
Other recruiting trials for Psychiatric Disorders
Currently open trials in the same condition.
- NCT07373223 — Virtual Reality Schema Therapy Exercises With Parent and Child Modes · NA · recruiting
- NCT07417813 — A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders · recruiting
- NCT06564948 — Treatment for Individuals Interacting with the Criminal Justice System · NA · recruiting
- NCT06754163 — Evaluating the Effect of the STEP@STAH Semaglutide Protocol on the Physical Health Measures of Atypical Antipsychotic-Tr · Phase 4 · active not recruiting
- NCT07023419 — Psychiatric Disorders in Addiction - Interest of Screening and Influence on Relapse · recruiting
Other Lone Baandrup trials
Trials by the same sponsor.
- NCT04105231 — Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06062953 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lone Baandrup
- Last refreshed: 24 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06062953.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing