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

Condition(s) targeted: Seasonal Affective Disorder

Intervention: Ramelteon (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Lehigh Valley Hospital

Official(s) and/or principal investigator(s):
Edward R Norris, MD, Principal Investigator, Affiliation: Lehigh Valley Hospital

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

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

Study design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Change from baseline in sleep satisfaction as measured by the Pittsburgh Sleep Quality Index

Secondary outcome:

Change from baseline in depressive symptoms as measured by the ZUNG Depression Scale

Change from baseline in depressive symptoms as measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGN-SAD)

Detailed description: Seasonal affective disorder(SAD) is a type of depression in which a patient's depressive symptoms worsen in the winter. These patient's 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 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, in addition, do so in an manner that may also reduce their seasonal affective depressive symptoms. Patients eligible for enrollment will 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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 COPD

- Prescription fluvoxamine(Luvox) use

Lehigh Valley Hospital, Department of Psychiatry, Allentown, Pennsylvania 18103, United States

Starting date: September 2006
Ending date: April 2008
Last updated: February 13, 2008