Melatonin In Acute Mania Investigation (MIAMI-uk)

Phase 2

Completed

• Conditions: Bipolar disorder; Mental and Behavioural Disorders; Bipolar affective disorder

• Registration Number: ISRCTN28988273
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-16
• Study Completion: 2012-06-29
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 41

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

1. Clinically significant substance abuse
2. Comorbid Axis 1 disorders (DSM4)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Young Mania Rating Scale at baseline, days 4, 7, 14 and 21.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Activity on the Actiwatch to continue for 21 days<br> 2. Quick Inventory of depressive symptoms C16 (Clinician) at baseline, days 4, 7, 14 and 21<br> 3. Quick Inventory of depressive symptoms SR16 (self report) at baseline, days 4, 7, 14 and 21<br> 4. Altman mania rating scale at baseline, days 4, 7, 14 and 21<br> 5. Adverse events. Duration of follow-up: 21 days<br> 6. Leeds Sleep Evaluation Questionnaire (LSEQ), carried out at baseline, day 4, day 7, day 14 and day 21<br>