Effects of Ramelteon (8mg) Alone and in Combination With Multi-Component Behavioral Therapy on Sleep and Circadian Phase in Patients With Chronic Insomnia (CBT)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|