Sleep Initiation and Maintenance DisordersPhase 4NCT00227942
Estrogen for Treating Depression in Menopausal Women With Hot Flashes and Insomnia
A Phase 4 study testing Estrogen Replacement Therapy and Zolpidem in people with Sleep Initiation and Maintenance Disorders and Depression, run by Hadine Joffe, MD at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of estrogen replacement therapy in treating depression in menopausal women with hot flashes and insomnia. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Depression
- What is being tested?
- Estrogen Replacement Therapy and Zolpidem
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Nov 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Center for Perinatal and Women's Mental Health
Boston, Massachusetts, 02116
About this study
Official title: Understanding the Role That Hot Flashes and Sleep Disruption Play in the Effect of Estrogen Replacement Therapy on Mood in Perimenopausal and Postmenopausal Women
This study will evaluate the effectiveness of estrogen replacement therapy in treating depression in menopausal women with hot flashes and insomnia.
Read the detailed description
Estrogen is a hormone that plays an important part in the development of the female reproductive system. During menopause, estrogen levels drop significantly. The drop in estrogen may cause physiologic and psychological changes in women; common symptoms include hot flashes, sweating, insomnia, and irritability. In addition, approximately 10% of menopausal women experience depression. Estrogen replacement therapy (ERT) is often prescribed to alleviate these symptoms. It is not known, however, exactly how ERT treats depression. It may indirectly decrease depression by alleviating insomnia associated with hot flashes, or it may directly improve mood and decrease depression by altering chemicals in the brain. The purpose of this study is to gain insight into how ERT treats depression and to develop strategies to reduce depression in menopausal women. In turn, these findings may help categorize populations of women whose depression should be treated with ERT versus nonhormonal therapies.
In this 9-week study, participants will be randomly assigned to receive ERT, a sleeping pill, or placebo. Study visits will occur at baseline and Weeks 2, 4, 6, and 9; at each study visit, blood pressure will be monitored, and standardized psychological tests and questionnaires will be used to assess the participant's level of depression and reported quality of life outcomes. Blood will be drawn at baseline and Week 9 to measure estrogen and follicle stimulating hormone levels.
- Being tested
- Estrogen Replacement Therapy, Zolpidem, placebo
- Keywords
- Women, Menopause, Depression, Hot flash, Insomnia, Sleep Disruption, Estrogen Replacement Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estrogen Replacement TherapyDrug
Also called Climara
17-b-Estradiol Patch, .05 mg/day; applied for 7 days
ZolpidemDrug
Also called Ambien
10 mg/day, po qhs
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive estrogen replacement therapy Receives: Drug: Estrogen Replacement Therapy |
| 2 | Experimental | Participants will receive treatment with zolpidem Receives: Drug: Zolpidem |
| 3 | Placebo comparator | Participants will receive treatment with placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale
Measured: 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: Measured at at baseline and Weeks 2, 4, 6, and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startAug 2003
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadine Joffe, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Hadine Joffe, MD, Massachusetts General Hospital
- Investigators
- Hadine Joffe, MD, MSC, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227942
- Sponsor's protocol ID
- K23MH066978
- Other IDs
- K23MH066978, DATR AK-TNAI1
- Status last verified
- May 2014
- First submitted
- 26 Sep 2005
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27648659
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Role That Hot Flashes and Sleep Disruption Play in the Effect of Estrogen Replacement Therapy on Mood in Perimenopausal and Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00227942
- Acronym / sponsor ID
- K23MH066978
- Keywords
- Women, Menopause, Depression, Hot flash, Insomnia, Sleep Disruption, Estrogen Replacement Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Hadine Joffe, MDUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2003
- Study completion
- Nov 2007 (actual)
- First posted
- 28 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of estrogen replacement therapy in treating depression in menopausal women with hot flashes and insomnia.
Detailed description
Estrogen is a hormone that plays an important part in the development of the female reproductive system. During menopause, estrogen levels drop significantly. The drop in estrogen may cause physiologic and psychological changes in women; common symptoms include hot flashes, sweating, insomnia, and irritability. In addition, approximately 10% of menopausal women experience depression. Estrogen replacement therapy (ERT) is often prescribed to alleviate these symptoms. It is not known, however, exactly how ERT treats depression. It may indirectly decrease depression by alleviating insomnia associated with hot flashes, or it may directly improve mood and decrease depression by altering chemicals in the brain. The purpose of this study is to gain insight into how ERT treats depression and to develop strategies to reduce depression in menopausal women. In turn, these findings may help categorize populations of women whose depression should be treated with ERT versus nonhormonal therapies.
In this 9-week study, participants will be randomly assigned to receive ERT, a sleeping pill, or placebo. Study visits will occur at baseline and Weeks 2, 4, 6, and 9; at each study visit, blood pressure will be monitored, and standardized psychological tests and questionnaires will be used to assess the participant's level of depression and reported quality of life outcomes. Blood will be drawn at baseline and Week 9 to measure estrogen and follicle stimulating hormone levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Estrogen Replacement TherapyParticipants will receive estrogen replacement therapy |
| 2 | Experimental | Drug: ZolpidemParticipants will receive treatment with zolpidem |
| 3 | Placebo comparator | Drug: placeboParticipants will receive treatment with placebo |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estrogen Replacement TherapyAlso: Climara17-b-Estradiol Patch, .05 mg/day; applied for 7 days | Drug | 1 |
| ZolpidemAlso: Ambien10 mg/day, po qhs | Drug | 2 |
| placeboplacebo | Drug | 3 |
Primary outcome
Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale
Time frame: Measured at at baseline and Weeks 2, 4, 6, and 9
1 secondary outcome
Quality of life indicators; measured by the Quality of Life Inventory
Time frame: Measured at at baseline and Weeks 2, 4, 6, and 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- Derived from this study: PubMed 27648659Galvan 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.
- Click here for the Massachusetts General Hospital Center for Women's Mental Health web site.Link provided by the sponsor.
Related trials for Sleep Initiation and Maintenance Disorders
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadine Joffe, MD, MSC principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Estrogen Replacement Therapy and Zolpidem in people with Sleep Initiation and Maintenance Disorders and Depression, run by Hadine Joffe, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale (time frame: Measured at at baseline and Weeks 2, 4, 6, and 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00227942, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2014; AzTrials last refreshed its copy on 7 Nov 2026.