Skip to main content
OpenTrials
Completed

NCT Number: NCT00502320

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Seasonal Affective Disorder Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lehigh Valley Hospital, Department of Psychiatry

Allentown, Pennsylvania, 18103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramelteon

Drug

one 8 mg tablet at bed for up to 4 months

Other names: Rozerem

Placebo

Drug

one tablet at bedtime for up to 4 months

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. 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)

    Self-rated scale to measure severity of depressive symptoms. Score ranges from 25-100, higher scores reflect more depression.

  2. 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)

    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.

Sponsors and collaborators

Lead sponsor

Lehigh Valley Hospital

Other

Collaborators

  • Takeda Pharmaceuticals North America, Inc.

Registry information

Official study title

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

Acronym: SAM-SAD

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 17, 2007
Registry last updated
Oct 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.