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

Phase 4

Completed

• Conditions: Seasonal Affective Disorder
• Interventions: Drug: Placebo; Drug: Ramelteon

• Registration Number: NCT00502320
• Lead Sponsor: Lehigh Valley Hospital

Brief Summary

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

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-17
• Primary Completion: 2008-04
• Study Completion: 2008-07
• Results First Submitted: 2009-07-21
• Results First Submitted QC: 2009-08-28
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-02
• Results First Posted: 2009-10-05
• Last Update Posted: 2009-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Ramelteon	Ramelteon	8 mg

Primary Outcome Measures

Name	Time	Method
Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)	Monthly for duration of treatment (up to 4 months)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lehigh Valley Hospital, Department of Psychiatry; 🇺🇸 Allentown, Pennsylvania, United States