Bipolar disorder Mental and Behavioural Disorders Bipolar affective disorder
Conditions
Interventions
Melatonin (circadin) 2 mg tablet orally at night 1 hour 30 min before sleep, or placebo for 21 days.
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age limit from 18 to 65, both genders 2. Young Mania Rating Scale >=20 3. In or out-patients meeting the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM4) criteria for bipolar disorder 4. Currently experiencing manic symptoms 5. Capacity to give informed consent
Exclusion criteria
Exclusion criteria: 1. Clinically significant substance abuse 2. Comorbid Axis 1 disorders (DSM4)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Young Mania Rating Scale at baseline, days 4, 7, 14 and 21. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Activity on the Actiwatch to continue for 21 days 2. Quick Inventory of depressive symptoms C16 (Clinician) at baseline, days 4, 7, 14 and 21 3. Quick Inventory of depressive symptoms SR16 (self report) at baseline, days 4, 7, 14 and 21 4. Altman mania rating scale at baseline, days 4, 7, 14 and 21 5. Adverse events. Duration of follow-up: 21 days 6. Leeds Sleep Evaluation Questionnaire (LSEQ), carried out at baseline, day 4, day 7, day 14 and day 21 | — |
Countries
United Kingdom
Outcome results
None listed