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

ConditionsPsychiatric Disorders Insomnia

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age16-64

SponsorLone Baandrup

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Current treatment with melatonin or quetiapine

Severe somatic comorbidity

BMI ≥ 35 kg/m2

Breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

Melatonin
Drug
3-9 mg flexible dosing before bed time
Quetiapine
Drug
50-150 mg flexible dosing before bed time
Placebo
Drug
1-3 capsules flexible dosing before bed time

Treatment groups

255 Participants

are divided into 3 treatment groups

Group A: MelatoninExperimental treatment 1 intervention

Group B: QuetiapineExperimental treatment 1 intervention

Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Insomnia severity

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

Time frame

6 weeks

Secondary outcomes

Clinical global impression (CGI)

Clinical global impression: Severity, range 0-7, higher is worse

Time frame

6 weeks

Subjective sleep quality

Pittsburgh Sleep Quality Index, range 0-21, higher is worse

Time frame

6 weeks

Psychosocial functioning

Personal and Social Performance Scale, range 1-100, higher is better

Time frame

6 weeks

Patient-reported subjective well-being

WHO-5 well-being index, range 0-100, higher is better

Time frame

6 weeks

Other outcomes

Objective sleep quality (polysomnography)

Total sleep time in minutes, higher is better

Time frame

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

Time frame

6 weeks

Locations

Map coordinates are unavailable for these locations. Locations are shown below instead.

Mental Health Center CopenhagenRecruiting2400, Copenhagen NV Denmark

Denmark

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lone Baandrup

Lead sponsor

University of Copenhagen

Sponsor institution

Danish Center for Sleep Medicine

Collaborator

Region Capital Denmark

Collaborator

Copenhagen Trial Unit, Center for Clinical Intervention Research

Collaborator

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Collaborator

Source ClinicalTrials.gov

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