NCT00227942

Brief Summary

This study will evaluate the effectiveness of estrogen replacement therapy in treating depression in menopausal women with hot flashes and insomnia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_4

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

August 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

First QC Date

September 26, 2005

Last Update Submit

May 23, 2014

Conditions

Sleep Initiation and Maintenance DisordersDepression

Keywords

WomenMenopauseDepressionHot flashInsomniaSleep DisruptionEstrogen Replacement Therapy

Outcome Measures

Primary Outcomes (1)

  • Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale

    Measured at at baseline and Weeks 2, 4, 6, and 9

Secondary Outcomes (1)

  • Quality of life indicators; measured by the Quality of Life Inventory

    Measured at at baseline and Weeks 2, 4, 6, and 9

Study Arms (3)

1

EXPERIMENTAL

Participants will receive estrogen replacement therapy

Drug: Estrogen Replacement Therapy

2

EXPERIMENTAL

Participants will receive treatment with zolpidem

Drug: Zolpidem

3

PLACEBO COMPARATOR

Participants will receive treatment with placebo

Drug: placebo

Interventions

Estrogen Replacement TherapyDRUG

17-b-Estradiol Patch, .05 mg/day; applied for 7 days

Also known as: Climara
1
ZolpidemDRUG

10 mg/day, po qhs

Also known as: Ambien
2
placeboDRUG

placebo

3

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Perimenopausal or postmenopausal status
  • Surgical menopause or hysterectomy with one or both ovaries preserved if serum follicle stimulating hormone is greater than 20 IU/L
  • Diagnosed with mild to moderate clinical depression
  • Currently experiencing moderate to severe hot flashes
  • Currently experiencing insomnia caused by nocturnal hot flashes
  • Normal mammogram within the 2 years prior to study entry
  • Willing to use an effective form of contraception throughout the study if perimenopausal and sexually active

You may not qualify if:

  • Current severe depression or history of severe depression within the 5 years prior to study entry
  • Suicidal or homicidal ideation
  • Psychotic symptoms
  • History of any psychiatric disorder (e.g., psychosis, bipolar disorder, panic disorder, obsessive-compulsive disorder, or anorexia nervosa)
  • History of any substance abuse (including alcohol abuse) within the 5 years prior to study entry
  • Regular use of hormonal medications within the month prior to study entry
  • Regular use of hypnotic drugs, antidepressants, or over-the-counter drugs known to influence hot flashes, sleep, or mood within the 2 weeks prior to study entry
  • Intolerance to estrogen therapy or informed that estrogen therapy is medically inadvisable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH Center for Perinatal and Women's Mental Health

Boston, Massachusetts, 02116, United States

Location

Related Publications (1)

  • Galvan T, Camuso J, Sullivan K, Kim S, White D, Redline S, Joffe H. Association of estradiol with sleep apnea in depressed perimenopausal and postmenopausal women: a preliminary study. Menopause. 2017 Jan;24(1):112-117. doi: 10.1097/GME.0000000000000737.

    PMID: 27648659DERIVED

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDepressionHot Flashes

Interventions

Estrogen Replacement TherapyEstradiolZolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormone Replacement TherapyDrug TherapyTherapeuticsEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hadine Joffe, MD, MSC

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Research at the Center for Women's Mental Health

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 28, 2005

Study Start

August 1, 2003

Study Completion

November 1, 2007

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations

US(1)