NCT00593736

Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome

A Randomized, Double-Blind, Placebo-Controlled, Parallel, Proof of Concept Study to Evaluate the Effectiveness of Ramelteon to Advance the Timing of Sleep in Individuals With Delayed Sleep Phase Syndrome (DSPS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.

Detailed description

Delayed sleep phase syndrome is the most common circadian disorder in adolescents and most adults with the condition report onset of symptoms during childhood or adolescence. Delayed Sleep Phase Syndrome involves a chronic mismatch between the usual daily schedule required by the individual's environment and his or her circadian sleep wake pattern. Individuals suffering from delayed Sleep Phase Syndrome experience great difficulty when attempting to fall asleep before 1-2 am, if not later, as well as rising at acceptable hours of the morning despite having completely normal sleep architecture and sleep duration. Delayed Sleep Phase Syndrome is a sleep disorder that results from a dysregulation of the circadian sleep-wake rhythm. Delayed Sleep Phase Syndrome is often the cause of severe insomnia and is associated with excessive daytime sleepiness, major depressive disorder and severe disruption of education, work and social functioning. Its major symptom is extreme difficulty initiating sleep at a conventional hour and waking on time in the morning for school or work. Ramelteon is a selective melatonin type 1 (MT1) and type 2 (MT2) receptor agonist. The purpose of this study is to evaluate the ability of ramelteon to advance the timing of sleep in individuals with delayed sleep phase syndrome. The effect of ramelteon will be analyzed based on collection of information from a post-sleep questionnaire completed by participants, and data collected by polysomnography in a sleep clinic setting. Total participation time involved in this study will be approximately 7 weeks.

Conditions

• Sleep Disorders, Circadian Rhythm

Interventions

Type	Name	Description
DRUG	Ramelteon	Ramelteon 1 mg, tablets, orally, once daily for up to two weeks.
DRUG	Ramelteon	Ramelteon 4 mg, tablets, orally, once daily for up to two weeks.
DRUG	Ramelteon	Ramelteon 8 mg, tablets, orally, once daily for up to two weeks.
DRUG	Placebo	Ramelteon placebo-matching tablets, orally, once daily for up to two weeks.

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-01-15
• Last updated: 2012-02-28
• Results posted: 2010-03-09

Locations

42 sites across 1 country: United States