NCT06062953

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for phase_2

Timeline
34mo left

Started Sep 2023

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Sep 2023Feb 2029

First Submitted

Initial submission to the registry

September 13, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

5.5 years

First QC Date

September 13, 2023

Last Update Submit

April 21, 2025

Conditions

Psychiatric DisordersInsomnia

Outcome Measures

Primary Outcomes (1)

  • Insomnia severity

    Insomnia Severity Index, range 0-28, higher is worse

    6 weeks

Secondary Outcomes (4)

  • Clinical global impression (CGI)

    6 weeks

  • Subjective sleep quality

    6 weeks

  • Psychosocial functioning

    6 weeks

  • Patient-reported subjective well-being

    6 weeks

Other Outcomes (2)

  • Objective sleep quality (polysomnography)

    6 weeks

  • Circadian rhythmicity (actigraphy)

    6 weeks

Study Arms (3)

Melatonin

EXPERIMENTAL
Drug: Melatonin

Quetiapine

EXPERIMENTAL
Drug: Quetiapine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MelatoninDRUG

3-9 mg flexible dosing before bed time

Melatonin
QuetiapineDRUG

50-150 mg flexible dosing before bed time

Quetiapine
PlaceboDRUG

1-3 capsules flexible dosing before bed time

Placebo

Eligibility Criteria

Age16 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Center Copenhagen

Copenhagen NV, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Mental DisordersSleep Initiation and Maintenance Disorders

Interventions

MelatoninQuetiapine Fumarate

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsDibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-Ring

Study Officials

  • Lone Baandrup, MD

    Mental Health Center Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lone Baandrup, MD

CONTACT

+4591165903lone.baandrup@regionh.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-investigator

Study Record Dates

First Submitted

September 13, 2023

First Posted

October 2, 2023

Study Start

September 18, 2023

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publication of planned primary, secondary and exploratory outcomes. There will be no end date for availability of data.
Access Criteria
Meta-analytical purposes

Locations

DK(1)