A randomized double-blind placebo-controlled trial of treatment as usual plus exogenous slow-release melatonin (6 mg) or placebo for sleep disturbance and depressed mood.
Study Goal
The researchers aimed to determine whether exogenous melatonin acts as a sleep promoter and antidepressant in individuals with major depressive disorder (MDD) and early-morning waking.
Results Summary
The study found general improvements in depression and sleep over time, but these were not specific to melatonin. However, there was a trend toward mood improvement with melatonin, and no adverse side effects were observed.
Population
33 participants with MDD and early-morning waking (31 completed the trial).
Effective Dosage
6 mg slow-release melatonin at bedtime.
Duration
4 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
melatonin | neutral | - | - | - | is a hypnotic | #1 |
melatonin | neutral | circadian rhythms | - | - | synchronizes | #2 |
melatonin | neutral | an antidepressant | - | - | may also be | #3 |
melatonin agonists, ramelteon and agomelatine | neutral | hypnotic and antidepressant properties | - | - | have | #4 |
slow-release melatonin (6 mg) | increase | depression and sleep | participants with a Diagnostic and Statistical Manual of Mental Disorders (fourth edition) diagnosis of MDD and early-morning waking | - | showed significant improvements | #5 |
slow-release melatonin (6 mg) | no change | improvements in depression and sleep | participants with a Diagnostic and Statistical Manual of Mental Disorders (fourth edition) diagnosis of MDD and early-morning waking | - | was not specific to | #6 |
melatonin | increase | mood | participants with a Diagnostic and Statistical Manual of Mental Disorders (fourth edition) diagnosis of MDD and early-morning waking | - | there was a trend towards an improvement | #7 |
melatonin | no change | adverse side effects | participants with a Diagnostic and Statistical Manual of Mental Disorders (fourth edition) diagnosis of MDD and early-morning waking | - | no adverse side effects were observed | #8 |
melatonin | neutral | MDD | - | - | may be beneficial for treating | #9 |
melatonin | neutral | safety and tolerability | - | - | seems to be safe and well tolerated | #10 |
Sleep disturbance is common in major depressive disorder (MDD), and is often characterized by early-morning waking. Melatonin is a hypnotic and synchronizes circadian rhythms. It may also be an antidepressant. The melatonin agonists, ramelteon and agomelatine, have hypnotic and antidepressant properties, but there is a dearth of trials investigating the use of melatonin in MDD. This randomized, controlled trial aimed to determine whether exogenous melatonin is a sleep promoter and antidepressant. Thirty-three participants with a Diagnostic and Statistical Manual of Mental Disorders (fourth edition) diagnosis of MDD and early-morning waking were selected for a 4-week, randomized, double-blind trial of slow-release melatonin (6 mg; vs. placebo) given at bedtime over 4 weeks. Sleep was measured subjectively using sleep diaries and the Leeds Sleep Evaluation Questionnaire and objectively using wrist actigraphy. Of the 33 participants, 31 completed the trial. General Linear Modelling showed significant improvements in depression and sleep over time, but this was not specific to melatonin. However, there was a trend towards an improvement in mood with melatonin, and no adverse side effects were observed. In conclusion, melatonin may be beneficial for treating MDD, it seems to be safe and well tolerated, but its potential for treating depression in people who do not wish to take antidepressants requires further evaluation.