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

Lehigh Valley Hospital50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Seasonal Affective Disorder

Interventions

RamelteonDRUG

one 8 mg tablet at bed for up to 4 months

PlaceboDRUG

one tablet at bedtime for up to 4 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Lehigh Valley Hospital, Department of Psychiatry

Allentown, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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