NCT00502320

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Lehigh Valley Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Seasonal Affective Disorder

Interventions

Type	Name	Description
DRUG	Ramelteon	one 8 mg tablet at bed for up to 4 months
DRUG	Placebo	one tablet at bedtime for up to 4 months

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-04-01
• Completion: 2008-07-01
• First posted: 2007-07-17
• Last updated: 2009-10-06
• Results posted: 2009-10-05

Locations

1 site across 1 country: United States