Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder (SAM-SAD)

Lehigh Valley Hospital

Status and phase: Completed; Phase 4

Conditions: Seasonal Affective Disorder

Treatments: Drug: Placebo; Drug: Ramelteon

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00502320

06-006R

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Ramelteon

Experimental group

Description:

8 mg

Treatment:

Drug: Ramelteon

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo