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

NCT ID: NCT00502320

Last Updated: 2009-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-07-31

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.

Conditions

Seasonal Affective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ramelteon

8 mg

Group Type: EXPERIMENTAL

Ramelteon

Intervention Type: DRUG

one 8 mg tablet at bed for up to 4 months

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

one tablet at bedtime for up to 4 months

Interventions

Ramelteon

one 8 mg tablet at bed for up to 4 months

Intervention Type: DRUG

Placebo

one tablet at bedtime for up to 4 months

Intervention Type: DRUG

Other Intervention Names

Rozerem

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda Pharmaceuticals North America, Inc.

INDUSTRY

Sponsor Role: collaborator

Lehigh Valley Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lehigh Valley Hospital

Principal Investigators

Edward R. Norris, MD

Role: PRINCIPAL_INVESTIGATOR

Lehigh Valley Hospital

Locations

Lehigh Valley Hospital, Department of Psychiatry

Allentown, Pennsylvania, United States

Countries

United States

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Other Identifiers

06-006R

Identifier Type: -

Identifier Source: org_study_id