Insomnia
Conditions
Keywords
Melatonin, Cognitive Behavior Therapy
Brief 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.
Interventions
DRUGPlacebo
Placebo pill nightly for 42 nights.
DRUGRozerem 8mg
Rozerem 8mg pill, nightly for 42 nights
OTHERRozerem 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.
Sponsors
University of Colorado, Denver
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Medical and sleep/wake history. During the screening process, participants will receive a physical exam, urine and blood labs, and be interviewed about their medical and sleep/wake history and be asked questions about their present and past habitual sleep/wake schedule and nap times. (b) Medication/drug/alcohol use. Participants must have no history of drug or alcohol abuse or dependency, consume no more than 2 alcoholic beverages a day or more than 14 per week, Participants must agree not to consume more than 2 beverages containing caffeine (caffeinated coffee, tea, colas) a day before 2 pm and none after 2 pm. (c) Evaluation of Psychiatric/Psychological Suitability. Participants must demonstrate a full understanding of the requirements and demands of the study. For inclusion/exclusion screening, participants will receive a sleep, medical, physical and psychiatric history examination, one-night of dim light melatonin onset evaluation in the sleep laboratory, one-night of polysomnography, and two weeks of baseline sleep assessment. If during the polysomnography assessment the participant had a respiratory disturbance index (RDI) of 15 or more, the participant would be considered to have met the exclusionary criterion for obstructive sleep apnea. A letter providing feedback of the all night polysomnography assessment will be sent to all participants. Individuals with a history of psychiatric illnesses or psychiatric disorders will be excluded, such as but not limited to, alcoholism, drug dependency, mood disorders; schizophrenic disorders, anxiety disorders; personality disorders. Finally, individuals who are unaware of specific psychiatric diagnoses who have a history of having been treated with antidepressants, neuroleptic medications or major tranquilizers will be excluded from study. However, a personal history of limited prior counseling or psychotherapy (e.g., for adjustment reactions) will not be exclusionary. Individuals who have been treated for insomnia within the past six months will be excluded.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Onset Latency | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dim Light Melatonin Onset | 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. |
Countries
United States
Outcome results
None listed