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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborator: |
Sepracor, Inc. |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00374192 |
Purpose
To examine the change in sleep patterns and mood symptoms in response to eszopiclone (Lunesta) using a double-blind placebo-controlled cross-over study design in perimenopausal and postmenopausal women who experience insomnia, mild depression and/or anxiety.
| Condition | Intervention |
|---|---|
|
Menopause Insomnia |
Drug: Eszopiclone Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | The Treatment of Insomnia in Symptomatic Peri- and Postmenopausal Women |
| Enrollment: | 67 |
| Study Start Date: | February 2006 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Eszopiclone
|
Drug: Eszopiclone
3 mg per day
|
|
2: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo
|
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subject must have any of the following perimenopausal or postmenopausal signs and symptoms as defined by the Stages of Reproductive Aging Workshop (STRAW):
One or both the following insomnia symptoms for ³ 3 nights per week for at least one month prior to study enrollment:
Mild depression and/or anxiety at screening visit defined as:
Exclusion Criteria:
According to M.I.N.I (Mini International Neuropsychiatric Interview), subject meets current or past criteria for past 3 months:
Subject has:
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Lee S. Cohen, MD | MGH |
More Information
| Responsible Party: | Massachusetts General Hospital ( Lee S. Cohen ) |
| Study ID Numbers: | 2006-P000194 |
| Study First Received: | September 8, 2006 |
| Last Updated: | August 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00374192 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Menopause Insomnia Depression Anxiety |
Sleep Lunesta Quality of Life |
|
Sleep Initiation and Maintenance Disorders Mental Disorders Nervous System Diseases |
Sleep Disorders Dyssomnias Sleep Disorders, Intrinsic |