Trial Outcomes & Findings for Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder (NCT NCT00502320)

Results Overview

Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Score ranges from 0-21, higher scores represent more significant sleep disturbance.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

Monthly for duration of treatment (up to 4 months)

Results posted on

2009-10-06

Participant Flow

Recruitment began in August 2006 and was completed by October 2007. 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 no compensation for participating in the study.

50 individuals signed the informed consent document, one was a screen failure, so 49 participants started study medication. During the study, both treatment groups were maintained on their usual medications for depression and allowed treatment as usual, including medication adjustments.

Participant milestones

Participant milestones
Measure	Ramelteon 8 mg pill taken by mouth nightly	Placebo inactive sugar pill taken by mouth nightly
Overall Study STARTED	25	25
Overall Study Screening Visit	25	24
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Ramelteon 8 mg pill taken by mouth nightly	Placebo inactive sugar pill taken by mouth nightly
Overall Study Lost to Follow-up	1	1
Overall Study Withdrew Consent	1	0
Overall Study No longer met criteria	1	0
Overall Study Screen Failure	0	1
Overall Study Adverse Event	3	5

Baseline Characteristics

Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ramelteon n=25 Participants 8 mg pill taken by mouth nightly	Placebo n=25 Participants inactive sugar pill taken by mouth nightly	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	45.49 years STANDARD_DEVIATION 11.81 • n=5 Participants	47.76 years STANDARD_DEVIATION 10.23 • n=7 Participants	46.08 years STANDARD_DEVIATION 11.04 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Monthly for duration of treatment (up to 4 months)

Population: Intention to Treat analysis; excludes one screen failure.

Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Score ranges from 0-21, higher scores represent more significant sleep disturbance.

Outcome measures

Outcome measures
Measure	Ramelteon n=25 Participants 8 mg pill taken by mouth nightly	Placebo n=24 Participants inactive sugar pill taken by mouth nightly
Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI) Baseline	11.56 scores on a scale Standard Error 0.75	11.45 scores on a scale Standard Error 0.77
Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI) Month 1	9.52 scores on a scale Standard Error 0.84	8.67 scores on a scale Standard Error 0.90
Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI) Month 2	7.57 scores on a scale Standard Error 0.84	8.62 scores on a scale Standard Error 0.89
Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI) Month 3	8.07 scores on a scale Standard Error 0.83	9.88 scores on a scale Standard Error 0.85
Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI) Month 4	7.05 scores on a scale Standard Error 0.85	9.61 scores on a scale Standard Error 0.87

SECONDARY outcome

Timeframe: Monthly for duration of treatment (up to 4 months)

Population: Intention to Treat analysis; excludes one screen failure.

Self-rated scale to measure severity of depressive symptoms. Score ranges from 25-100, higher scores reflect more depression.

Outcome measures

Outcome measures
Measure	Ramelteon n=25 Participants 8 mg pill taken by mouth nightly	Placebo n=24 Participants inactive sugar pill taken by mouth nightly
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS) Baseline	63.06 scores on a scale Standard Error 1.92	58.63 scores on a scale Standard Error 1.96
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS) Month 1	54.35 scores on a scale Standard Error 2.70	56.40 scores on a scale Standard Error 2.86
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS) Month 2	53.51 scores on a scale Standard Error 2.71	58.59 scores on a scale Standard Error 2.80
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS) Month 3	49.26 scores on a scale Standard Error 2.81	58.62 scores on a scale Standard Error 2.89
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS) Month 4	46.14 scores on a scale Standard Error 2.65	61.65 scores on a scale Standard Error 2.74

SECONDARY outcome

Timeframe: Monthly for duration of treatment (up to 4 months)

Population: Intention to Treat analysis; excludes one screen failure.

Clinician-rated measure of mood; evaluates classical 21 Hamilton Depression items, and 8-item subscale measuring atypical depression symptoms which commonly occur during SAD episodes. Score ranges from 0-89, higher scores indicate higher levels of depression.

Outcome measures

Outcome measures
Measure	Ramelteon n=25 Participants 8 mg pill taken by mouth nightly	Placebo n=24 Participants inactive sugar pill taken by mouth nightly
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD) Baseline	22.68 scores on a scale Standard Error 1.60	19.99 scores on a scale Standard Error 1.63
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD) Month 1	16.16 scores on a scale Standard Error 1.88	15.97 scores on a scale Standard Error 2.04
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD) Month 2	14.81 scores on a scale Standard Error 1.90	19.47 scores on a scale Standard Error 1.96
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD) Month 3	11.69 scores on a scale Standard Error 1.66	20.65 scores on a scale Standard Error 1.67
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD) Month 4	9.15 scores on a scale Standard Error 1.67	23.68 scores on a scale Standard Error 1.71

Adverse Events

Ramelteon

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ramelteon 8 mg pill taken by mouth nightly	Placebo inactive sugar pill taken by mouth nightly
Psychiatric disorders Worsening depression leading to hospitalization	4.0% 1/25 • Number of events 1	0.00% 0/24

Other adverse events

Other adverse events
Measure	Ramelteon 8 mg pill taken by mouth nightly	Placebo inactive sugar pill taken by mouth nightly
Psychiatric disorders Anxiety	4.0% 1/25 • Number of events 1	0.00% 0/24
Psychiatric disorders Depression	4.0% 1/25 • Number of events 1	4.2% 1/24 • Number of events 1
General disorders Fatigue	4.0% 1/25 • Number of events 1	4.2% 1/24 • Number of events 1
General disorders Insomnia Exacerbation	4.0% 1/25 • Number of events 1	12.5% 3/24 • Number of events 3
General disorders Nightmares	4.0% 1/25 • Number of events 1	0.00% 0/24

Additional Information

Edward R. Norris, MD

Lehigh Valley Hospital

Phone: 610-402-5766

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place