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

Seasonal Affective Disorder Clinical Trial

— SAM-SAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502320
• Other study ID #: 06-006R
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2007
• Last updated: October 2, 2009
• Start date: September 2006
• Est. completion date: July 2008

Study information

• Verified date: October 2009
• Source: Lehigh Valley Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mood Disorders
• Seasonal Affective Disorder

Intervention

Drug:
• Ramelteon
one 8 mg tablet at bed for up to 4 months
• Placebo
one tablet at bedtime for up to 4 months

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital, Department of Psychiatry	Allentown	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Lehigh Valley Hospital	Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)		Monthly for duration of treatment (up to 4 months)	No
Secondary	Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)		Monthly for duration of treatment (up to 4 months)	No
Secondary	Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)		Monthly for duration of treatment (up to 4 months)	No