NCT00374192

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

August 10, 2009

Status Verified

August 1, 2009

Enrollment Period

1.4 years

First QC Date

September 8, 2006

Last Update Submit

August 7, 2009

Conditions

MenopauseInsomnia

Keywords

MenopauseInsomniaDepressionAnxietySleepLunestaQuality of Life

Outcome Measures

Primary Outcomes (1)

  • To examine the effect of treatment with eszopiclone on sleep-onset and sleep-maintenance insomnia in peri- and postmenopausal women.

    4 weeks

Secondary Outcomes (1)

  • 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.

    4 weeks

Study Arms (2)

1

EXPERIMENTAL

Eszopiclone

Drug: Eszopiclone

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

EszopicloneDRUG

3 mg per day

Also known as: Lunesta
1
PlaceboDRUG

Placebo

2

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women 40+ years old.
  • Subject must have any of the following perimenopausal or postmenopausal signs and symptoms as defined by the Stages of Reproductive Aging Workshop (STRAW):
  • Early Menopausal Transition (Stage -2): Variable cycle length \>7 days different from normal.
  • Late Menopausal Transition (Stage -1) : \> 2 skipped cycles and an interval of amenorrhea \> 60 days.
  • Post Menopause (Stage +1): Amenorrhea for at least 12 months.
  • Surgical Post Menopause
  • Hysterectomized women with one or both ovaries preserved will be eligible if FSH levels \> 20 IU/L.
  • If on hormonal therapy, history of menstrual-cycle abnormalities consistent with any of 2a-2e above indicating peri-/postmenopausal status prior to initiation of hormonal therapy.
  • One or both the following insomnia symptoms for ³ 3 nights per week for at least one month prior to study enrollment:
  • Difficulty initiating sleep (³ 30 minutes)
  • Difficulty maintaining sleep (wake time after sleep onset ³ 30 minutes)
  • Daytime function or well-being is impaired as a result of insomnia.
  • Mild depression and/or anxiety at screening visit defined as:
  • Mild Depressive symptoms defined by Montgomery-Åsberg Depression Rating Scale-MADRS (MADRS) ³ 10 administered at screening visit, or
  • Mild Anxiety symptoms defined by Beck Anxiety Inventory (BAI) ³ 10 administered at screening visit.
  • +5 more criteria

You may not qualify if:

  • According to M.I.N.I (Mini International Neuropsychiatric Interview), subject meets current or past criteria for past 3 months:
  • Major Depression
  • Dysthymia
  • Panic disorder
  • PTSD (Post-Traumatic Stress Disorder)
  • According to M.I.N.I, subject has no evidence of current suicidal ideation, homicidal ideation, or psychotic symptoms at screening visit.
  • Suicide attempt in the past 5 years.
  • According to M.I.N.I, subject meets criteria for substance use disorder diagnosis within the past 5 years.
  • Subject has current or recent use (in the past month and used \> 25% of time) of hypnotic agents.
  • Subject is on an antidepressant or hormone therapy in past 2 months. (Unless they are taking currently and have had a stable dose for ≥ 2 months).
  • Subject has:
  • Unstable medical abnormality
  • Unstable chronic disease.
  • History of significant cardiac, renal, or hepatic disease, or seizure disorder.
  • Regular use of any disallowed medication (Including; Clarithromycin, Itraconazole, Ketoconazole, Nefazodone, Nelfinavir, Olanzapine, Rifampin, Ritonavir, Troleandomycin) currently or in the past month.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDepressionAnxiety Disorders

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesPyridines

Study Officials

  • Lee S. Cohen, MD

    MGH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 11, 2006

Study Start

February 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

August 10, 2009

Record last verified: 2009-08

Locations

US(1)