Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in... | NCT06062953

Studies
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia

NCT06062953

Sponsor

Lone Baandrup

Status

Recruiting

Last Update Posted

Apr 24, 2025Actual

Enrollment

255Estimated

Phase

Phase 2Phase 3

Conditions

Psychiatric Disorders
Insomnia

Interventions

Melatonin
Quetiapine
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 18, 2023Actual

Primary Completion Date

Feb 28, 2029Estimated

Completion Date

Feb 28, 2029Estimated

First Submitted Date

Sep 13, 2023

First Submission Date that Met QC Criteria

Sep 25, 2023

First Posted Date

Oct 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2025

Last Update Posted Date

Apr 24, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lone Baandrup, Sponsor-investigator, University of CopenhagenSponsor-Investigator

Lead Sponsor

Lone BaandrupOTHER

Collaborators

Name	Class
Danish Center for Sleep Medicine	OTHER
Region Capital Denmark	OTHER
Copenhagen Trial Unit, Center for Clinical Intervention Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

255Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Melatonin	Experimental	Drug: Melatonin
Quetiapine	Experimental	Drug: Quetiapine
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Melatonin	Drug	3-9 mg flexible dosing before bed time	Melatonin
Quetiapine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insomnia severity	Insomnia Severity Index, range 0-28, higher is worse	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Clinical global impression (CGI)	Clinical global impression: Severity, range 0-7, higher is worse	6 weeks
Subjective sleep quality	Pittsburgh Sleep Quality Index, range 0-21, higher is worse

Other Outcomes

Measure	Description	Time Frame
Objective sleep quality (polysomnography)	Total sleep time in minutes, higher is better	6 weeks
Circadian rhythmicity (actigraphy)	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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

64 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lone Baandrup, MD	Contact	+4591165903		lone.baandrup@regionh.dk

Overall Officials

Name	Affiliation	Role
Lone Baandrup, MD	Mental Health Center Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mental Health Center Copenhagen	Recruiting	Copenhagen NV		2400	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Study Protocol
Statistical Analysis Plan (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

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001523	Mental Disorders
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008550	Melatonin
D000069348	Quetiapine Fumarate

Ancestor Terms

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided