The Treatment of Insomnia in Symptomatic Peri- and Postmenopausal Women
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Treatment of Insomnia in Symptomatic Peri- and Postmenopausal Women|
- To examine the effect of treatment with eszopiclone on sleep-onset and sleep-maintenance insomnia in peri- and postmenopausal women. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- To examine the effect of eszopiclone on mood and quality of life in peri- and postmenopausal women with insomnia who have comorbid depressive and/or anxiety symptoms. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
3 mg per day
Other Name: Lunesta
Placebo Comparator: 2
The study design is a double-blinded placebo-controlled cross-over study that will be completed at the MGH site. It is an 11-week study of insomnia, mild mood, and anxiety symptoms in peri- and postmenopausal women age 40 years or older. Subjects who are enrolled will have 5 office visits during the 11-week long study.
Various studies have identified female gender as a strong risk factor for insomnia, (Ford & Kamerow, 1989; Klink et al, 1992; Li et al, 2002);community-based studies that examined gender differences in insomnia complaints have consistently shown a higher prevalence of insomnia among women than among men. It has been hypothesized that insomnia might be an overlooked complaint among women seeking treatment in the primary care setting.
Insomnia and other sleep disturbances may be reported during specific situations associated with the female reproductive cycle, such as pregnancy (Sahota et al, 2003) and menopause (Joffe et al, 2003). Complaints of sleep-onset and sleep-maintenance insomnia are among the most common symptoms in peri- and postmenopausal women. This sleep disturbance frequently co-occurs with hot flushes and depression symptoms. The menopausal transition is also a period of heightened vulnerability to mood and anxiety disturbances, and significant vasomotor symptoms (i.e. hot flushes and night sweats) which may affect functioning and quality of life.
Consented subjects will track their sleep patterns for one week using a sleep diary to confirm that they have either difficulty initiating sleep (³ 30 minutes) or difficulty maintaining sleep (wake time after sleep onset ³ 30), for ≥ 3 nights during 7-day observation period. Those who are confirmed to meet these insomnia criteria will be randomized in a 1-to-1 fashion to cross-over treatment starting with either eszopiclone or placebo.
In addition to taking the daily medication, and coming to the office visits, subjects will complete a daily diary throughout the study. This diary is completed to assess insomnia symptoms throughout the duration of the study. Treatment assignments will be revealed at final study visit to the participant, research coordinator, and study physician.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374192
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Lee S. Cohen, MD||MGH|