Conditions: Sleep Disorders, Circadian Rhythm
Keywords: Delayed sleep phase syndrome; drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 132
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Ramelteon intervention 2: Ramelteon intervention 3: Ramelteon intervention 4: Placebo
Intervention descriptions: intervention 1: Ramelteon 1 mg, tablets, orally, once daily for up to two weeks. intervention 2: Ramelteon 4 mg, tablets, orally, once daily for up to two weeks. intervention 3: Ramelteon 8 mg, tablets, orally, once daily for up to two weeks. intervention 4: Ramelteon placebo-matching tablets, orally, once daily for up to two weeks.

Protocol document: