Clinical trial NCT00502320: Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder
Official title: Randomized Placebo-Controlled Trial of Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Affective Disorder
Keywords: Seasonal Affective Disorder
Ramelteon
Psychiatry
Randomized Controlled Trial
Hamilton Depression Rating Scale- SAD Version
Circadian Rhythm
Lead sponsor: Lehigh Valley Hospital
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2007-07-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 chronic obstructive pulmonary disease (COPD)
* Prescription fluvoxamine(Luvox) use

Primary outcomes:
measure: Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Monthly for duration of treatment (up to 4 months)
Secondary outcomes:
measure: Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)
timeFrame: Monthly for duration of treatment (up to 4 months)
measure: Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)
timeFrame: Monthly for duration of treatment (up to 4 months)
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Lehigh Valley Hospital, Department of Psychiatry
state: Pennsylvania
Study officials:
affiliation: Lehigh Valley Hospital
name: Edward R. Norris, MD
role: PRINCIPAL_INVESTIGATOR
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