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| ID | Type | Description | Link |
|---|---|---|---|
| Grant ID: 10.46540/00004B | Other Grant/Funding Number | Danmarks Frie Forskningsfond (DFF) |
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The objective with this study is to conduct a 6-month RCT comparing effects of add-on melatonin versus add-on placebo on mood stabilisation and other critical patient outcomes in patients with BD and to test whether principal effects are antimanic, antidepressant and/or prophylactic against relapse
Sleep abnormalities are common in all phases of bipolar disorder (BD) and constitute core symptoms of both depression and mania also during remitted phases and despite treatment.
Melatonin is a key circadian hormone, that expresses a robust circadian rhythm and acts as an important endogenous modulator of the circadian timing system of sleep and may thus improve sleep and stabilize BD per se. Nevertheless, sleep in general and melatonin specifically is critically understudied in BD reflecting a central key knowledge gap within psychiatry. The investigators want in a 6-month randomized placebo-controlled trial (RCT) to compare effects of add on melatonin versus add on placebo on mood stabilisation and other critical patient outcomes in patients with BD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Active Comparator | 100 BD patients will receive 6 mg melatonin every evening. Patients, clinicians and researchers will be blinded. |
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| Placebo | Placebo Comparator | 100 BD patients will receive placebo. Patients, clinicians and researchers will be blinded. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | Oral: Melatonin capsule 6 mg, 1 capsule/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mood stabilization | Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system. Patients score their daily mood on a 9-point scale (-3 to +3); scores between -0.5 to 0.5 reflect normal variations, whereas scores of +1, +2 or +3 correspond to mildly, moderately, and severely increased mood and scores of -1, -2 or -3 correspond to mildly, moderately, and severely decreased mood. According to our established methodology, for each participant, we will estimate a mood instability score. Estimates of instability will be based on reading obtained via the Monsenso system which will prompt patients to complete daily mood ratings. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep | Change in sleep measured by change from baseline on the Pittsburgh Sleep Quality Index (min. value = 0; max. value = 21 with higher scores indicating poorer sleep quality) on 3 months visit and 6 months visit | 6 months |
| Depression |
| Measure | Description | Time Frame |
|---|---|---|
| Mania/hypomania | The clinical rating of (hypo)mania is assessed using the Young Mania Rating Scale (YMRS) (Min. value = 0; max. value = 60 with higher values reflecting more manic symptoms) [Clinically rated observer-based difference in scores over the 6 months trial, measured at baseline, 3 months and 6 months] | Changes between baseline, 3 months and 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Kessing | Contact | +45 38647081 | lars.vedel.kessing@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lars Kessing | University hospital Bispebjerg and Frederiksberg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Center Copenhagen, Copenhagen Affective Research Center (CADIC) | Recruiting | Frederiksberg | 2000 | Denmark |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Double-blinded randomized placebo-controlled trial
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| Placebo |
| Drug |
Oral Placebo capsule, 1 capsule/day |
|
The clinical rating of depression is assessed using the Hamilton Rating Scale for Depression, 6 items (HAM-D6), (min. value=0; max. value = 22 with higher scores reflecting more severe depression )
| Changes between baseline, 3 months and 6 months |
| Functioning | Functioning is assessed using the Functional Assessment Short Test (FAST) (Min. value = 0, max. value = 72 with higher values reflecting poorer function). | Changes between baseline, 3 months and 6 months |
| Perceived stress | Assessed using Cohen's Perceived Stress Scale (PSS), a 10-item questionnaire. (Min. value = 0; max. value = 40, with higher values reflecting increased stress level) | Changes between baseline, 3- and 6 months |
| Cognition | Assessed using the self-administered questionnaire, Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) (Min. value = 0; max. value = 48, the higher the score, the higher the number of subjective complaints) | Changes between baseline and 6 months |
| Non-response to standard mood stabilizing treatment | Non-response to standard mood stabilizing treatment, where standard treatment is defined as lithium or lamotrigine. If one of the following situations occurs after treatment allocation, the date is registrered as "non-response to treatment" defined as:
| 6 months |
| Chronotype | Assessed using the Morningness-Eveningness questionnaire (MEQ). (Min. value 16, max. value 86. A value of 41 or below indicate an "evening type". Value of 59 or above indicate a "morning type". Values between 42-58 indicate an "intermediate type") | 6 months |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |