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

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
Lehigh Valley Hospital
ClinicalTrials.gov Identifier:
NCT00502320
First received: July 13, 2007
Last updated: October 2, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Seasonal Affective Disorder
Drug: Ramelteon
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Placebo-Controlled Trial of Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder

Resource links provided by NLM:


Further study details as provided by Lehigh Valley Hospital:

Primary Outcome Measures:
  • Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Monthly for duration of treatment (up to 4 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS) [ Time Frame: Monthly for duration of treatment (up to 4 months) ] [ Designated as safety issue: No ]
  • Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD) [ Time Frame: Monthly for duration of treatment (up to 4 months) ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2006
Study Completion Date: July 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramelteon
8 mg
Drug: Ramelteon
one 8 mg tablet at bed for up to 4 months
Other Name: Rozerem
Placebo Comparator: Placebo Drug: Placebo
one tablet at bedtime for up to 4 months

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502320

Locations
United States, Pennsylvania
Lehigh Valley Hospital, Department of Psychiatry
Allentown, Pennsylvania, United States, 18103
Sponsors and Collaborators
Lehigh Valley Hospital
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Edward R. Norris, MD Lehigh Valley Hospital
  More Information

Publications:
Thompson, C. (2001). Evidence-based treatment. In Seasonal Affective Disorder: Practice and Research (ed. T. Partonen and A. Magnusson), 151-158. New York: Oxford University Press.
Zung WWK. (1967). Factors influencing the Self-Rated Depression Scale. Arch Gen Psychiatry 16:543-547.

Responsible Party: Edward R. Norris, MD, Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT00502320     History of Changes
Other Study ID Numbers: 06-006R
Study First Received: July 13, 2007
Results First Received: July 21, 2009
Last Updated: October 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Lehigh Valley Hospital:
Seasonal Affective Disorder
Ramelteon
Psychiatry
Randomized Controlled Trial
Hamilton Depression Rating Scale- SAD Version
Circadian Rhythm

Additional relevant MeSH terms:
Disease
Mood Disorders
Seasonal Affective Disorder
Depressive Disorder
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014