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

Last updated: October 2, 2009
Sponsor: Lehigh Valley Hospital
Overall Status: Completed

Phase

4

Condition

Mood Disorders

Affective Disorders

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT00502320
06-006R
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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

Total Participants: 50
Study Start date:
September 01, 2006
Estimated Completion Date:
July 31, 2008

Study 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.

Connect with a study center

  • Lehigh Valley Hospital, Department of Psychiatry

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

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