Effects of Ramelteon (8mg) Alone and in Combination With Multi-Component Behavioral Therapy on Sleep and Circadian Phase in Patients With Chronic Insomnia (CBT)
|ClinicalTrials.gov Identifier: NCT01180855|
Recruitment Status : Unknown
Verified August 2010 by University of Arizona.
Recruitment status was: Active, not recruiting
First Posted : August 12, 2010
Last Update Posted : August 12, 2010
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Drug: Placebo Drug: Rozerem 8mg Other: Rozerem 8mg in combination with Multi Component Behavior Therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||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)|
|Study Start Date :||August 2007|
|Estimated Primary Completion Date :||September 2010|
|Estimated Study Completion Date :||September 2010|
Placebo Comparator: Placebo
Placebo pills prepared by Takeda Pharmaceutical.
Placebo pill nightly for 42 nights.
Active Comparator: Rozerem
Drug: Rozerem 8mg
Rozerem 8mg pill, nightly for 42 nights
Active Comparator: Rozerem + Multi Component Behavior Therapy
Rozerem 8mg in combination with 4 small group sessions and 2 phone calls of Multi Component Behavior Therapy.
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.
- Sleep Onset Latency [ Time Frame: Baseline, Post treatment, 3 month follow up ]Daily assessment of sleep and daytime functioning (daily voice mail sleep diary and actigraphy) for 10 weeks: 2 weeks prior to and after treatment and during the 6 week treatment period. The primary sleep outcomes will be improvement in sleep onset latency (SOL) and total sleep time (TST).
- Dim Light Melatonin Onset [ Time Frame: Baseline, post treatment ]Assessment of circadian melatonin phase 2 weeks prior to and 2 weeks after treatment(dim light melatonin onset—DLMO, 2 weeks prior to treatment and 2 weeks post treatment assessment of quality of life (SF-36) and sleep quality (Pittsburgh Sleep Quality Index—PSQI), 2 weeks prior to treatment and 2 weeks post treatmemnt daily assessment of daytime functioning.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180855
|United States, Arizona|
|University of Arizona Sleep Research Laboratory|
|Tucson, Arizona, United States, 85721|
|Principal Investigator:||Richard R Bootzin, PhD||University of Arizona|