The effect of 12 weeks Melatonin administration on depressive symptoms in youth with major depressive disorders - A Randomised, Placebo-controlled, Double-blinded Trial.

Phase 3

• Conditions: Depression; Sleep Disturbance; Mental Health - Depression; Mental Health - Other mental health disorders

• Registration Number: ACTRN12624000017527
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-01-10
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 579

Inclusion Criteria

•Aged between 18 and 30 inclusive at the time of providing informed consent
•Current MDD according to the Structured Clinical Interview for DSM-5 (SCID-5)
•Quick Inventory of Depressive Symptomatology, Adolescent version, self-rated (QIDS-A-SR) score > 11, indicating moderate-to-severe MDD, within 14 days of the first treatment visit
•Pittsburgh Sleep Quality Index score >5 (general sleep disturbance) and/or Epworth Sleepiness Scale score >10 (suggestive of hypersomnia) and/or self-reported delayed sleep phase (habitual bed-time between 02:00-06:00) or irregular sleep cycles
•Ability to provide written informed consent (including both adequate intellectual capacity and fluency in the English language)

Exclusion Criteria

•History of psychosis or bipolar type I or II (assessed with SCID-5)
•Use of any form of melatonin or melatonin agonist within six weeks of the first treatment visit
•Self-reported significant impaired kidney/ liver function (i.e., liver/kidney disease diagnosed)
•Self-reported autoimmune conditions (e.g. rheumatoid arthritis, post-organ transplant)
•Risk of difficulty with blood collection (e.g., poor vein visibility, previous incidence of fainting/significant discomfort during blood collection)
•Self-reported sleep, respiratory (e.g., sleep apnoea), neurological, or medical conditions that could contribute to sleep-wake dysfunction
•Self-reported allergy to melatonin or Microcrystalline Cellulose
•Self-reported pregnancy or breastfeeding
•Recent initiation (past 3 months) of new medication
•Presence of a substance use disorder of at least moderate severity (according to DSM-5) within the preceding 6 months
•Acute suicidal behaviour (score of 6 on Comprehensive Assessment of At-Risk Mental States item 7.3)
•Participation in another trial of a sleep or circadian therapy within one month of the trial commencing
•Regular shift work within 60-days prior to entry into the study.
•Recent transmeridian travel across two or more time zones in the past one month

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the effect of a 12-week course of 2mg oral melatonin as an adjunct to treatment as usual, relative to placebo and dCBT-I, in effecting depressive symptoms (through the QIDS-A-CR) [ The primary endpoint will be any changes in depressive symptoms (QIDS-A-CR) from baseline to weeks 4, 8 and 12 ];To determine the effect of a 12-week course of 2mg oral melatonin as an adjunct to treatment as usual, relative to placebo and dCBT-I, in effecting the clinical trajectory of major depressive disorder (MDD) (through the SCID-5) in young adults (18 to 30 years of age) with moderate-to-severe MDD.<br><br>[ The primary endpoint will be any changes to MDD severity (SCID-5) at week 12. ]