Melatonin in Acute Mania Investigation (MIAMI-UK) - Melatonin in Acute Mania Investigation Version 3.0

Phase 1

• Conditions: Bipolar Disorder (mania and hypomania); MedDRA version: 12 Level: LLT Classification code 10000852 Term: Acute Mania; MedDRA version: 12 Level: LLT Classification code 10021030 Term: Hypomania

• Registration Number: EUCTR2008-000281-23-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-18
• Study Completion: 2012-06-29
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

Inclusion Criteria: • In or outpatients meeting DSM-IV criteria for bipolar disorder type 1 or 2 • Currently experiencing manic or hypomanic symptoms. • Minimum score on Young Mania Rating Scale (YMRS) (>/=20) • Informed consent possible or previously obtained. • Willing to allow his or her General Practitioner and consultant to be notified of participation in the study. • Aged 18-65
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria: The participant may not enter the study if ANY of the following apply: • Clinically significant illicit substance or alcohol misuse where dependence criteria are satisfied – craving on abstinence, withdrawal symptoms develop and are relieved by the substance, an effect on the behavioural activity of the individual to procure the substance on a predictable basis and an effect on the socio-occupational or relational functioning of the individual. • Comorbid Axis 1 disorders (according to DSM-4 Diagnostic Classification system). • Significant abnormalities on physical examination at the commencement of the trial, necessitating further investigation by a General Practitioner. • Patients currently taking Beta-blocker type medication . Patients suffering from auto-immune disease. • Patients taking the SSRI anti-depressant fluvoxamine, 5- and 8- methoxypsoralens, hormonal medications, quinolones or cimetidine, as these could interact with the drug to increase melatonin levels. • Patients taking carbamazepine or rifampicin, as these could interact with the drug to reduce melatonin levels.. . Females who are pregnant or breast-feeding. . Patients who have to undertake tasks where drowsiness could increase risk.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified