Efficacy of melatonin, low-dose quetiapine, or placebo in patients with psychiatric disorders and comorbid insomnia: a randomized clinical trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Hovedstadens Psykiatriske, Psykiatrisk Center Kobenhavn

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

15 Sep 2023 → ongoing

Decision date (initial)

2023-07-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Independent Research Fund Denmark (DFF, grant ID: 10.46540/2096-00086B)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The objective of the trial is to examine the efficacy of melatonin versus low-dose quetiapine versus placebo as augmentation to treatment as usual in patients with psychiatric disorders and comorbid chronic insomnia.

Secondary objectives 4

1. To examine how melatonin or low-dose quetiapine affects global symptom severity
2. To examine how melatonin or low-dose quetiapine affects sleep quality
3. To examine how melatonin or low-dose quetiapine affects psychosocial functioning
4. To examine how melatonin or low-dose quetiapine affects subjective well-being

Conditions and MedDRA coding

Psychiatric disorder (ICD-10 F20-F69, F84, F90-F95) and insomnia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 18 to 64 years of age
2. ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-F95)
3. For the diagnoses F84 and F90 a previous period of treatment with melatonin is required
4. Self-reported sleep difficulties at least three times per week in the preceding 3 months
5. Insomnia Severity Index score ≥11
6. Women of childbearing potential: negative pregnancy test at baseline and use of highly effective contraception measures
7. Informed consent

Exclusion criteria 8

1. Current treatment with melatonin or quetiapine
2. Severe somatic comorbidity
3. BMI ≥ 35 kg/m2
4. Breastfeeding
5. Alcohol and/or substance dependency (F1X.2) within the last 3 months
6. Inadequate Danish language skills
7. Not able to make an informed consent
8. Increased cardiac risk as assessed by presence of cardiac risk factors, cardiac symptoms, or prolonged QT-interval at baseline ECG

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Insomnia severity using the Insomnia Severity Index (ISI)

Secondary endpoints 4

1. Clinical global impression (CGI)
2. Subjective sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
3. Psychosocial functioning using the Personal and Social Performance Scale (PSP)
4. Patient-reported subjective well-being using the WHO-5 well-being index

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstadens Psykiatriske

Sponsor organisation

Region Hovedstadens Psykiatriske

Address

Nordre Ringvej 69

City

Glostrup

Postcode

2600

Country

Denmark

Scientific contact point

Organisation

Region Hovedstadens Psykiatriske

Contact name

Lone Baandrup

Public contact point

Organisation

Region Hovedstadens Psykiatriske

Contact name

Lone Baandrup

Third parties 1

Psykiatrisk Center Kobenhavn

Sponsor organisation

Psykiatrisk Center Kobenhavn

Address

Edel Sauntes Alle 10

City

Copenhagen Oe

Postcode

2100

Country

Denmark

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

4 submissions — initial application plus substantial / non-substantial modifications