Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began in October 2007 and was completed by August 2009. Participants, who at the time were receiving outpatient psychiatric services through Lehigh Valley Hospital, were recruited via referral through the department of psychiatry, and also through print advertisement. Participants received a $20 travel stipend for each appointment.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
90 participants signed the informed consent document, 7 were screen failures, and 83 were randomized to receive either Ramelteon or placebo. During the study, both groups were maintained on their usual medications for bipolar disorder and were not allowed to have any meds changed, as this would signify a manic or depressed event.

Reporting Groups

	Description
Ramelteon	one 8 mg tablet at bedtime for up to 6 months
Placebo	one tablet at bedtime for up to 6 months

Participant Flow:   Overall Study

	Ramelteon	Placebo
STARTED	42	41
COMPLETED	16	8
NOT COMPLETED	26	33
Adverse Event	3	5
Relapsed- Depressed Event	10	16
Relapse- Manic Event	3	3
Relapsed- Mixed Event	3	5
Protocol Violation	0	1
Lost to Follow-up	1	1
Non-compliance	1	1
Medical Condition	1	1
Withdrawal by Subject	3	0
Medication Change	1	0

Reporting Groups

	Description
Ramelteon	one 8 mg tablet at bedtime for up to 6 months
Placebo	one tablet at bedtime for up to 6 months

Baseline Measures

	Ramelteon	Placebo	Total
Number of Participants   [units: participants]	42	41	83
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	42	41	83
>=65 years	0	0	0
Age   [units: years] Mean ± Standard Deviation	46.6  ± 11.0	45.2  ± 10.8	45.9  ± 10.9
Gender   [units: participants]
Female	26	26	52
Male	16	15	31
Region of Enrollment   [units: participants]
United States	42	41	83

1.  Primary:

Pittsburgh Sleep Quality Index (PSQI) Global Score   [ Time Frame: Monthly for 6 months ]

2.  Secondary:

Montgomery-Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Monthly for 6 months ]

3.  Secondary:

Young Mania Rating Scale (YMRS) Total Score   [ Time Frame: Monthly for 6 months ]

4.  Secondary:

Clinical Global Impressions Bipolar Version(CGI-BP) Severity of Illness Overall Score   [ Time Frame: Monthly for 6 months ]

5.  Secondary:

Cumulative Proportion of Participants in Each Arm Surviving Without Relapse   [ Time Frame: Monthly for 6 months ]