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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Lehigh Valley Hospital

Current Primary Outcome: Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Monthly for duration of treatment (up to 4 months) ]

Original Primary Outcome: Change from baseline in sleep satisfaction as measured by the Pittsburgh Sleep Quality Index [ Time Frame: Monthly for 4 months ]

Current Secondary Outcome:

  • Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS) [ 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) [ Time Frame: Monthly for duration of treatment (up to 4 months) ]


Original Secondary Outcome:

  • Change from baseline in depressive symptoms as measured by the ZUNG Depression Scale [ Time Frame: Monthly for 4 months ]
  • Change from baseline in depressive symptoms as measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGN-SAD) [ Time Frame: Monthly for 4 months ]


Information By: Lehigh Valley Hospital

Dates:
Date Received: July 13, 2007
Date Started: September 2006
Date Completion:
Last Updated: October 2, 2009
Last Verified: October 2009