Table of contents
- Overview of the Melatonin trials
- Sleep and psychiatry studies
- Studies in children after surgery and newborns
- Pain, neurological, and hormone-related studies
- Cancer and bipolar disorder studies
- Phases, outcomes, and study design
- Who can participate and what is compared
Overview of the Melatonin trials
These clinical trials study Melatonin in many different patient groups and conditions, rather than in one single disease area.[1]
The studies include people with sleep problems, psychiatric disorders, pain, mood disorders, multiple sclerosis, cancer, and other conditions, as well as children and newborns in hospital settings.[1][2]
The trials use different designs, including randomized, double-blind, and placebo-controlled studies, which means participants are assigned by chance and neither the patient nor the study team may know which treatment is given.[1][2]
Sleep and psychiatry studies
Several trials focus on insomnia in people with psychiatric disorders, including adolescents and adults with ICD-10 psychiatric diagnoses and chronic insomnia.[1][6]
In these studies, Melatonin is compared with low-dose quetiapine and with placebo, and the main outcome is insomnia severity measured by the Insomnia Severity Index (ISI).[1][6]
Another study in major depressive episode with insomnia tests a 2×2 factorial design, which means two treatments are studied alone and together in different groups.[5]
That study measures depressive symptoms with the Montgomery-Åsberg Depression Rating Scale (MADRS) after 8 weeks and looks at the effect of prolonged-release Melatonin, active light therapy, or both.[5]
Idiopathic hypersomnia is also being studied, with a 6-week chronobiotherapy plan that combines evening Melatonin and morning bright light therapy.[10]
The main outcome in that study is the change in the Idiopathic Hypersomnia Severity Scale (IHSS), which measures how severe the sleepiness symptoms are.[10]
Studies in children after surgery and newborns
One Phase 3 trial studies Melatonin in children to prevent agitation after surgery and emergence delirium, which means confusion or restlessness as the child wakes up from anesthesia.[2]
This study gives Melatonin intravenously during surgery and measures emergence agitation as the primary outcome.[2]
Another early Phase 1 study looks at newborns with moderate-severe hypoxic-ischaemic encephalopathy, a serious brain injury caused by low oxygen and low blood flow around birth.[3]
That study focuses first on safety, including dose-limiting events, and also checks whether planned blood levels of Melatonin and alcohol are reached during the safety window.[3]
The trial also aims to find the recommended Phase 2 dose, which is the dose chosen for the next stage of research.[3]
Pain, neurological, and hormone-related studies
Two Phase 3 trials study chronic back pain and chronic low back pain, both comparing daily Melatonin with placebo for 6 weeks.[4][8]
These studies measure the change in average pain intensity over the past 7 days using a 0 to 10 Numeric Rating Scale (NRS), where higher numbers mean worse pain.[4][8]
One completed Phase 1/2 trial in primary progressive multiple sclerosis looked at Melatonin together with ocrelizumab and measured disease progression using disability and neurological function scales.[7]
The outcomes included the Kurtzke Expanded Disability Status Scale and the Multiple Sclerosis Functional Composite, which are tools used to measure disability and function in multiple sclerosis.[7]
A Phase 3 study in postmenopausal women tests a combination of DHEA and prolonged-release Melatonin for 12 weeks and measures sleep quality, mood, daytime sleepiness, and menopausal vasomotor symptoms such as hot flashes.[6]
Cancer and bipolar disorder studies
One Phase 3 trial studies Melatonin as adjuvant treatment in uveal melanoma, which means treatment given after the main therapy to help improve outcomes.[9]
The main outcome is whether participants remain free from metastases, meaning cancer spread to other parts of the body, 5 years after randomization.[9]
Another authorised trial studies bipolar disorder in a 6-month randomized trial comparing Melatonin with placebo.[11]
That study looks at mood stabilization using a mood instability score based on daily self-monitored mood data collected through the Monsenso system.[11]
The study also wants to learn whether the main effect is antimanic, antidepressant, or prevention of relapse, but the primary outcome is mood stabilization.[11]
Phases, outcomes, and study design
The trials cover a wide range of phases, from Phase 1 safety work in newborns to Phase 4 studies in psychiatric disorders and adolescent insomnia.[1][3][6][11]
Later-phase studies often compare Melatonin with placebo or another active treatment to see if it improves symptoms more than the comparison group.[1][4][5][9][11]
Primary outcomes vary by condition and include insomnia severity, pain intensity, depressive symptoms, emergence agitation, disease progression, mood stability, and metastasis-free survival.[1][2][4][5][7][9][11]
Some trials are designed as superiority studies, meaning they test whether Melatonin works better than placebo for a specific outcome.[4][8]
Who can participate and what is compared
Participation depends on the trial and the condition being studied, so each study has its own target population.[1][2][3][4][5][6][7][8][9][10][11]
Some studies compare Melatonin with placebo, while others compare it with low-dose quetiapine or use it together with other treatments such as active light therapy, DHEA, or ocrelizumab.[1][5][6][7][10][11]
Across the trial list, Melatonin is being studied as a possible help for sleep, pain, mood, agitation after surgery, neurological disease outcomes, and cancer-related outcomes.[1][2][4][5][7][9][10][11]
