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

Study Overview
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Brief Summary
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The purpose of this study is to determine whether treating sleep difficulties in patients with seasonal affective disorder also improves their depressive symptoms.

Detailed Description
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Seasonal affective disorder(SAD) is a type of depression in which a patient's depressive symptoms worsen in the winter. These patients' depressive symptoms often lessen in the spring and summer months. Much of the focus of the treatment of SAD (light therapy and melatonin) has involved the brain's suprachiasmatic nucleus(SCN), as it is hypothesized that one potential reason for SAD is a desynchronized SCN. Ramelteon offers a new and more pharmacologically exact mechanism to re-synchronize the SCN. The administration of ramelteon for this patient population may improve sleep, and in addition, do so in a manner that may also reduce their seasonal affective depressive symptoms. Patients eligible for enrollment will be administered either ramelteon or placebo and return to the study office for 4 monthly visits over the winter months, to evaluate the effects of ramelteon versus placebo on sleep and mood.

Official Title
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Randomized Placebo-Controlled Trial of Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder

Conditions
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Seasonal Affective Disorder

Intervention / Treatment
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* Drug: Ramelteon
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age 18-65 yrs. A diagnosis of seasonal affective disorder A Pittsburgh Sleep Quality Index >5 English speaking Be able to sign informed consent Exclusion Criteria: Active substance abuse Current psychotic symptoms Severe personality disorders Primary sleep disorders Severe chronic obstructive pulmonary disease (COPD) Prescription fluvoxamine(Luvox) use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ramelteon<br>8 mg | Drug: Ramelteon<br>* one 8 mg tablet at bed for up to 4 months<br>* Other names: Rozerem;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* one tablet at bedtime for up to 4 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI) | 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. | Monthly for duration of treatment (up to 4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS) | Self-rated scale to measure severity of depressive symptoms. Score ranges from 25-100, higher scores reflect more depression. | Monthly for duration of treatment (up to 4 months) | 
| Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD) | 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. | Monthly for duration of treatment (up to 4 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seasonal Affective Disorder, Ramelteon, Psychiatry, Randomized Controlled Trial, Hamilton Depression Rating Scale- SAD Version, Circadian Rhythm