Menopausal DepressionPhase 2NCT01126801
Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women
A Phase 2 study testing Estradiol in people with Menopausal Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This protocol is a controlled study of estradiol therapy in early postmenopausal women with and without frequent hot flashes that will be used to determine whether hot flashes are an important intermediary in the generation of menopause-associated depression. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Depression
- What is being tested?
- Estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Feb 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy women ≥40 years-old
- Early postmenopausal, defined as:
- No menstrual bleeding for 12-60 months secondary to natural menopause, according to STRAW criteria48
- Hysterectomy without bilateral oophorectomy if surgery was completed after 6+ months of amenorrhea (no maximum duration of amenorrhea required)
- Bilateral oophorectomy (no minimum or maximum duration of amenorrhea required)
- Serum follicle-stimulating hormone (FSH) >25 IU/L and estradiol <20 pg/ml
Show all 10Show fewer
- Diagnosis of major depression on the MINI
- Mild-to-moderate depressive symptoms, as indicated by MADRS score 15-31 and BDI score >15
- Normal mammogram within the past 2 years
- Good general health
Who cannot join
- Severe depression, defined as a MADRS score >31, psychotic symptoms, or suicidal or homicidal ideation
- Psychiatric illness, as defined by clinical interview and the Mini-International Neuropsychiatric Interview (MINI), as:
- A lifetime history of bipolar disorder
- A lifetime history of severe depression, as characterized by current or prior psychotic symptoms, inpatient psychiatric hospitalization or a suicide attempt in the previous 5 years, or
- Current panic disorder or obsessive compulsive disorder
- A lifetime history of psychotic symptoms
Show all 26Show fewer
- Current anorexia nervosa
- An alcohol or substance-use disorder active within the past year
- Current suicidal or homicidal ideation
- Previous diagnosis of a sleep disorder (sleep apnea, PLMS, etc) or diagnosed on a screening PSG study
- Pregnant, confirmed with serum ß-HCG at baseline (Visit 1)
- Breastfeeding
- Contraindication, hypersensitivity, or previous adverse reaction to E2 therapy
- Current or recent (1 month) use of centrally active medications (antidepressants, anxiolytics, hypnotics, anticonvulsants, stimulants)
- Current or recent (2 months) use of systemic hormone medications
- History of breast cancer, premalignant breast lesions, or undiagnosed breast mass
- Vaginal spotting or bleeding
- History of thrombo-embolism, cardiovascular disease, congestive heart failure or other contraindication to estradiol therapy.
- Liver dysfunction or disease
- Renal insufficiency
- Contraindications to progestin therapy
- Asthma, diabetes mellitus, epilepsy, and migraine disorders that are not stable and under medical management
- Other medical contraindications to estradiol and progestin therapy including porphyria, systemic lupus erythematosus, hepatic hemangiomas, deep vein thrombosis, hereditary angioedema, hypertriglyceridemia, severe Hypocalcemia.
- Clinically significant abnormalities in screening blood tests including:
- Thyroid-stimulating hormone <0.50 or >5.0 uU/mL)
- Shift workers
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This protocol is a controlled study of estradiol therapy in early postmenopausal women with and without frequent hot flashes that will be used to determine whether hot flashes are an important intermediary in the generation of menopause-associated depression.
Read the detailed description
SPECIFIC AIMS (Research Objectives)
To define the relative effects of hot flashes and changes in estradiol on mood in postmenopausal women:
Hypotheses:
- Estrogen treatment has a similar therapeutic effect on mood in women with and without frequent hot flashes
- Estradiol levels correlate with improvement in mood
- Conditions
- Menopausal Depression
- Being tested
- Estradiol, Placebo control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstradiolDrug
Oral estradiol 1.0 mg/day for four weeks.
Placebo controlOther
Placebo control matched to estradiol tablets. Daily dosing for one month.
| Study group | Role | What they receive |
|---|---|---|
| Estradiol | Experimental | Not described Receives: Drug: Estradiol |
| Placebo control | Placebo comparator | Not described Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Mood, Measured by the Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to Study End.
Measured: one month
Secondary outcomes (1)
Improvement of Mood, Measured by the Self-rated Beck Depression Inventory (BDI) From Baseline to Study End.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Stopped enrolling subjects due to challenge of identifying eligible participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menopausal DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Hadine Joffe, MD, Brigham and Women's Hospital
- Investigators
- Hadine Joffe, MD MSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126801
- Sponsor's protocol ID
- 2009p001776
- Status last verified
- Sep 2017
- First submitted
- 11 May 2010
- Last updated
- 20 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01126801
- Acronym / sponsor ID
- 2009p001776
- Conditions
- Menopausal Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped enrolling subjects due to challenge of identifying eligible participants
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Posted 22 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol is a controlled study of estradiol therapy in early postmenopausal women with and without frequent hot flashes that will be used to determine whether hot flashes are an important intermediary in the generation of menopause-associated depression.
Detailed description
SPECIFIC AIMS (Research Objectives)
To define the relative effects of hot flashes and changes in estradiol on mood in postmenopausal women:
Hypotheses:
- Estrogen treatment has a similar therapeutic effect on mood in women with and without frequent hot flashes
- Estradiol levels correlate with improvement in mood
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estradiol | Experimental | Drug: Estradiol |
| Placebo control | Placebo comparator | Other: Placebo control |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy women ≥40 years-old
- Early postmenopausal, defined as:
- No menstrual bleeding for 12-60 months secondary to natural menopause, according to STRAW criteria48
- Hysterectomy without bilateral oophorectomy if surgery was completed after 6+ months of amenorrhea (no maximum duration of amenorrhea required)
- Bilateral oophorectomy (no minimum or maximum duration of amenorrhea required)
Key exclusion criteria (26 listed)
- Severe depression, defined as a MADRS score >31, psychotic symptoms, or suicidal or homicidal ideation
- Psychiatric illness, as defined by clinical interview and the Mini-International Neuropsychiatric Interview (MINI), as:
- Previous diagnosis of a sleep disorder (sleep apnea, PLMS, etc) or diagnosed on a screening PSG study
- Pregnant, confirmed with serum ß-HCG at baseline (Visit 1)
- Breastfeeding
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 |
|---|---|---|
| EstradiolOral estradiol 1.0 mg/day for four weeks. | Drug | Estradiol |
| Placebo controlPlacebo control matched to estradiol tablets. Daily dosing for one month. | Other | Placebo control |
Primary outcome
Improvement of Mood, Measured by the Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to Study End.
Time frame: one month
1 secondary outcome
Improvement of Mood, Measured by the Self-rated Beck Depression Inventory (BDI) From Baseline to Study End.
Time frame: one month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Related trials for Menopausal Depression
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Enrolling by invitationObservational study
Multidimensional Determinants of Functional Health In Women Aged 45-60
Healthy, Perimenopausal Depression
Recruiting
Study on Allopregnanolone and Depression in Women Across the Menopause Transition
Depression
Recruiting
Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction
Depression, Depression During the Menopausal Transition
RecruitingObservational study
CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life
Premenstrual Syndrome, Premenstrual Dysphoric Disorder
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
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Estradiol in people with Menopausal Depression, run by Massachusetts General Hospital 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 10 inclusion and 26 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: stopped early, as of the sponsor's last update on 20 Oct 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to Study End. (time frame: one month). 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 NCT01126801, 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 20 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.