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

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

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

Study Overview

• Status: Completed
• Conditions: Seasonal Affective Disorder
• Intervention / Treatment: Drug: Ramelteon; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; one tablet at bedtime for up to 4 months
Experimental: Ramelteon; 8 mg	Drug: Ramelteon; one 8 mg tablet at bed for up to 4 months; Other Names: Rozerem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)	Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Score ranges from 0-21, higher scores represent more significant sleep disturbance.	Monthly for duration of treatment (up to 4 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)	Self-rated scale to measure severity of depressive symptoms. Score ranges from 25-100, higher scores reflect more depression.	Monthly for duration of treatment (up to 4 months)
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)	Clinician-rated measure of mood; evaluates classical 21 Hamilton Depression items, and 8-item subscale measuring atypical depression symptoms which commonly occur during SAD episodes. Score ranges from 0-89, higher scores indicate higher levels of depression.	Monthly for duration of treatment (up to 4 months)

Collaborators and Investigators

• Sponsor: Lehigh Valley Hospital
• Collaborators: Takeda Pharmaceuticals North America, Inc.

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: July 13, 2007
• First Submitted That Met QC Criteria: July 13, 2007
• First Posted (Estimate): July 17, 2007

Study Record Updates

• Last Update Posted (Estimate): October 6, 2009
• Last Update Submitted That Met QC Criteria: October 2, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Psychiatry; Circadian Rhythm; Seasonal Affective Disorder; Ramelteon; Hamilton Depression Rating Scale- SAD Version
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Depressive Disorder; Disease; Mood Disorders; Seasonal Affective Disorder
• Other Study ID Numbers: 06-006R