NCT01180855

Effects of Ramelteon (8mg) Alone and in Combination With Multi-Component Behavioral Therapy on Sleep and Circadian Phase in Patients With Chronic Insomnia

Effects of Ramelteon (8mg) Alone and in Combination With Multi-Component Behavioral Therapy on Sleep and Circadian Phase in Patients With Chronic Insomnia: A Randomized, Double-Blind, Placebo Controlled Study (Investigator Initiated Study)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The specific aims of the proposed study are to compare the sleep, daytime functioning, and circadian phase effects of ROZEREMTM (ramelteon/TAK-375) a selective MT1/MT2 melatonin receptor agonist in humans alone and in combination with multi-component behavior therapy (MCBT) in patients with chronic insomnia.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Placebo	Placebo pill nightly for 42 nights.
DRUG	Rozerem 8mg	Rozerem 8mg pill, nightly for 42 nights
OTHER	Rozerem 8mg in combination with Multi Component Behavior Therapy	Rozerem 8mg pill nightly for 42 nights with 4 sessions and 2 telephone calls of Multi Component Behavior Therapy.

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-08-12
• Last updated: 2010-08-12

Locations

1 site across 1 country: United States