MenopausePhase 4NCT00626340

Brain Imaging Study in Menopausal Women With and Without Major Depressive Disorder

A Phase 4 study testing MDD diagnosis and Estrogen treatment, MDD diagnosis and Fluoxetine treatment and MDD diagnosis with both Estrogen and Fluoxetine treatment in people with Menopause and Depression, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: Menopause, Depression
What is being tested?: MDD diagnosis and Estrogen treatment, MDD diagnosis and Fluoxetine treatment and MDD diagnosis with both Estrogen and Fluoxetine treatment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Jul 1999to Jul 2008
Phase: Phase 4
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 to 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged 40-70 years and able to give voluntary written informed consent.
Meet DSM-IV criteria for major depression based on a structured clinical interview (SCID).
Have no medical contraindication to estrogen. (This will include written documentation of a recent normal gynecological evaluation and mammogram).
A minimum score of 25 on the 25-item Hamilton Depression Rating Scale on initial baseline rating which does not show improvement during the one-week observation period.
Perimenopausal subjects will be those who have had irregular menses of either <21 days or >35 days for the previous six months to one year. Postmenopausal subjects will be those with no menstrual cycles and no hormone therapy for at least one year and serum FSH >45.
No DSM-IV psychiatric or substance abuse diagnosis by structured diagnostic interview (SCID).

Show all 9Show fewer

No medical contraindication to estrogen (this will include written documentation of a recent normal gynecological exam with mammogram).
Matched to depressed patients by age and menopausal status.
Have no menstrual cycles or hormone therapy for at least one year or irregular menses of either <21 days or 35 days for the previous six months to one year.

Who cannot join

Meeting DSM-IV for any other Axis I disorder.
A history of serious medical or neurological illness, including (but not limited to) major cardiovascular disease, severe hypertension, intracranial mass lesions, seizure disorder, severe hepatic or renal disease, unstable endocrine or metabolic disease, and unstable hematologic disease.
A history of moderate to severe endometriosis; milder cases will require subject's Gynecologists permission to participate.
Use of anticonvulsants or benzodiazepines within the last month.
Use of psychotropic medication in last week (except as stated above).
Use of alcohol within last month.

Show all 16Show fewer

Current pregnancy (for the perimenopausal subjects).
Positive urine drug screen.
Metallic implants.
Medical, neurologic or cerebrovascular disorder (CVA, seizure disorder, etc.).
Evidence of substance use on urine toxicology screen done upon recruitment.
Current treatment with psychoactive medication.
Diabetes controlled by means other than diet.
Use of alcohol within last month.
Implanted metallic devices.
Positive urine drug screen.

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale University
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: Measurement of GABA and Neurosteroid Levels in Women With Menopausal Major Depression Before and After Treatment With Estrogen Alone, Fluoxetine Alone, or Estrogen and Fluoxetine and Normal Controls Before and After Treatment With Estrogen

The purpose this study is to measure cortical gama-aminobutyric acid levels (GABA) levels in menopausal women with major depressive disorder and healthy subjects using nuclear magnetic resonance spectroscopy (MRS). Measurements will be compared in 1) menopausal healthy subjects before and after estrogen replacement, and after fourteen days of medroxyprogesterone administration; and 2) in depressed menopausal subjects before and after treatment of their depression with antidepressant alone, estrogen alone or antidepressant plus estrogen. Cortical GABA levels will be correlated with plasma GABA and neurosteroid levels. Neurosteroids to be measured include progesterone, allopregnanolone, pregnenolone, and pregnenolone sulfate.

Conditions: Menopause, Depression
Being tested: MDD diagnosis and Estrogen treatment, MDD diagnosis and Fluoxetine treatment, MDD diagnosis with both Estrogen and Fluoxetine treatment, No depression and estrogen treatment
Keywords: menopause, women, major depressive disorder, Magnetic Resonance Spectroscopy
Medical subject headings: Depression, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MDD diagnosis and Estrogen treatmentDrug
Treatment for major depressive disorder occurring in the context of the menopause while participating in brain imaging sessions pre and post treatment. Women receiving treatment for depression will be compared to normal controls receiving estrogen only for physical symptoms of menopause.
MDD diagnosis and Fluoxetine treatmentDrug
Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone.
MDD diagnosis with both Estrogen and Fluoxetine treatmentDrug
Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.
No depression and estrogen treatmentDrug
Control participants with no MDD diagnosis received estrogen only for the treatment of physical symptoms of menopause.

Study groups in NCT00626340
Study group	Role	What they receive
MDD diagnosis and Estrogen treatment	Active comparator	Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen alone. Receives: Drug: MDD diagnosis and Estrogen treatment
MDD diagnosis and Fluoxetine treatment	Active comparator	Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone. Receives: Drug: MDD diagnosis and Fluoxetine treatment
MDD diagnosis with both Estrogen and Fluoxetine treatment	Active comparator	Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined. Receives: Drug: MDD diagnosis with both Estrogen and Fluoxetine treatment
No depression and estrogen treatment	Active comparator	Non-depressed menopausal women between the ages of 40-70 receiving treatment with estrogen alone. Receives: Drug: No depression and estrogen treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of Cortical GABA Levels in 4 Groups of Subjects Using Estrogen Alone, Fluoxetine Alone, Estrogen and Fluoxetine Combined in Pre and Post 4.0T Magnetic Resonance Spectroscopy Sessions.
This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
We only know that 18 participants completed, but as far as we know data was never analyzed for these 18 participants.
Measured: Healthy controls will undergo scans pre and post 3 weeks of estrogen treatment. Women with depression will undergo scans pre and post 6 weeks of treatment with estrogen alone, estrogen and fluoxetine, or fluoxetine alone

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 1999Jul 2008

First posted29 Feb 2008 (estimated)
Study startJul 1999
Primary completionJul 2008
Study completionJul 2008

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 (21)Papers the sponsor has linked to this study.
Other trials for MenopauseStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00626340
Sponsor's protocol ID: 9907010780
Status last verified: May 2017
First submitted: 21 Feb 2008
Last updated: 1 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Weissman MM, Klerman GL. Sex differences and the epidemiology of depression. Arch Gen Psychiatry. 1977 Jan;34(1):98-111. doi: 10.1001/archpsyc.1977.01770130100011.
PubMed 319772
Steiner M. Female-specific mood disorders. Clin Obstet Gynecol. 1992 Sep;35(3):599-611. doi: 10.1097/00003081-199209000-00020.
PubMed 1521388
Pariser SF. Women and mood disorders. Menarche to menopause. Ann Clin Psychiatry. 1993 Dec;5(4):249-54. doi: 10.3109/10401239309148824.
PubMed 8312982
Pearlstein TB. Hormones and depression: what are the facts about premenstrual syndrome, menopause, and hormone replacement therapy? Am J Obstet Gynecol. 1995 Aug;173(2):646-53. doi: 10.1016/0002-9378(95)90297-x.
PubMed 7645647
Nicol-Smith L. Causality, menopause, and depression: a critical review of the literature. BMJ. 1996 Nov 16;313(7067):1229-32. doi: 10.1136/bmj.313.7067.1229.
PubMed 8939110
Schmidt PJ, Rubinow DR. Menopause-related affective disorders: a justification for further study. Am J Psychiatry. 1991 Jul;148(7):844-52. doi: 10.1176/ajp.148.7.844.
PubMed 2053622
Arpels JC. The female brain hypoestrogenic continuum from the premenstrual syndrome to menopause. A hypothesis and review of supporting data. J Reprod Med. 1996 Sep;41(9):633-9.
PubMed 8887186
Lopez-Jaramillo P, Teran E, Molina G, Rivera J, Lozano A. Oestrogens and depression. Lancet. 1996 Jul 13;348(9020):135-6. doi: 10.1016/s0140-6736(05)64656-9. No abstract available.
PubMed 8676707
Ditkoff EC, Crary WG, Cristo M, Lobo RA. Estrogen improves psychological function in asymptomatic postmenopausal women. Obstet Gynecol. 1991 Dec;78(6):991-5.
PubMed 1658700
Schneider MA, Brotherton PL, Hailes J. The effect of exogenous oestrogens on depression in menopausal women. Med J Aust. 1977 Jul 30;2(5):162-3. doi: 10.5694/j.1326-5377.1977.tb99116.x.
PubMed 197385
Thomson J, Oswald I. Effect of oestrogen on the sleep, mood, and anxiety of menopausal women. Br Med J. 1977 Nov 19;2(6098):1317-9. doi: 10.1136/bmj.2.6098.1317.
PubMed 338104
Berlanga C. Potentiating effect of estrogen in a patient with treatment-resistant depression. J Clin Psychiatry. 1988 Dec;49(12):504. No abstract available.
PubMed 2848799
Oppenheim G. A case of rapid mood cycling with estrogen: implications for therapy. J Clin Psychiatry. 1984 Jan;45(1):34-5.
PubMed 6141158
Freeman EW, Purdy RH, Coutifaris C, Rickels K, Paul SM. Anxiolytic metabolites of progesterone: correlation with mood and performance measures following oral progesterone administration to healthy female volunteers. Neuroendocrinology. 1993 Oct;58(4):478-84. doi: 10.1159/000126579.
PubMed 7904330
Halbreich U, Petty F, Yonkers K, Kramer GL, Rush AJ, Bibi KW. Low plasma gamma-aminobutyric acid levels during the late luteal phase of women with premenstrual dysphoric disorder. Am J Psychiatry. 1996 May;153(5):718-20. doi: 10.1176/ajp.153.5.718.
PubMed 8615423

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measurement of GABA and Neurosteroid Levels in Women With Menopausal Major Depression Before and After Treatment With Estrogen Alone, Fluoxetine Alone, or Estrogen and Fluoxetine and Normal Controls Before and After Treatment With Estrogen
ClinicalTrials.gov ID: NCT00626340
Acronym / sponsor ID: 9907010780
Conditions: Menopause, Depression
Keywords: menopause, women, major depressive disorder, Magnetic Resonance Spectroscopy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: Jul 1999
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 29 Feb 2008 (estimated)
Results: Posted 1 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
MDD diagnosis and Estrogen treatment	Active comparator	Drug: MDD diagnosis and Estrogen treatmentMenopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen alone.
MDD diagnosis and Fluoxetine treatment	Active comparator	Drug: MDD diagnosis and Fluoxetine treatmentMenopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone.
MDD diagnosis with both Estrogen and Fluoxetine treatment	Active comparator	Drug: MDD diagnosis with both Estrogen and Fluoxetine treatmentMenopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.
No depression and estrogen treatment	Active comparator	Drug: No depression and estrogen treatmentNon-depressed menopausal women between the ages of 40-70 receiving treatment with estrogen alone.

Who may qualify

Ages: 40 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Aged 40-70 years and able to give voluntary written informed consent.
Meet DSM-IV criteria for major depression based on a structured clinical interview (SCID).
Have no medical contraindication to estrogen. (This will include written documentation of a recent normal gynecological evaluation and mammogram).
A minimum score of 25 on the 25-item Hamilton Depression Rating Scale on initial baseline rating which does not show improvement during the one-week observation period.
Perimenopausal subjects will be those who have had irregular menses of either <21 days or >35 days for the previous six months to one year. Postmenopausal subjects will be those with no menstrual cycles and no hormone therapy for at least one year and serum FSH >45.

Key exclusion criteria (16 listed)

Meeting DSM-IV for any other Axis I disorder.
A history of serious medical or neurological illness, including (but not limited to) major cardiovascular disease, severe hypertension, intracranial mass lesions, seizure disorder, severe hepatic or renal disease, unstable endocrine or metabolic disease, and unstable hematologic disease.
A history of moderate to severe endometriosis; milder cases will require subject's Gynecologists permission to participate.
Use of anticonvulsants or benzodiazepines within the last month.
Use of psychotropic medication in last week (except as stated above).

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
MDD diagnosis and Estrogen treatmentTreatment for major depressive disorder occurring in the context of the menopause while participating in brain imaging sessions pre and post treatment. Women receiving treatment for depression will be compared to normal controls receiving estrogen only for physical symptoms of menopause.	Drug	MDD diagnosis and Estrogen treatment
MDD diagnosis and Fluoxetine treatmentMenopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone.	Drug	MDD diagnosis and Fluoxetine treatment
MDD diagnosis with both Estrogen and Fluoxetine treatmentMenopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.	Drug	MDD diagnosis with both Estrogen and Fluoxetine treatment
No depression and estrogen treatmentControl participants with no MDD diagnosis received estrogen only for the treatment of physical symptoms of menopause.	Drug	No depression and estrogen treatment

Primary outcome

Comparison of Cortical GABA Levels in 4 Groups of Subjects Using Estrogen Alone, Fluoxetine Alone, Estrogen and Fluoxetine Combined in Pre and Post 4.0T Magnetic Resonance Spectroscopy Sessions.
Time frame: Healthy controls will undergo scans pre and post 3 weeks of estrogen treatment. Women with depression will undergo scans pre and post 6 weeks of treatment with estrogen alone, estrogen and fluoxetine, or fluoxetine alone
This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information. We only know that 18 participants completed, but as far as we know data was never analyzed for these 18 participants.

Results and safety

Results posted to the registry on 1 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	18	18

Primary outcome: Comparison of Cortical GABA Levels in 4 Groups of Subjects Using Estrogen Alone, Fluoxetine Alone, Estrogen and Fluoxetine Combined in Pre and Post 4.0T Magnetic Resonance Spectroscopy Sessions.

Time frame: Healthy controls will undergo scans pre and post 3 weeks of estrogen treatment. Women with depression will undergo scans pre and post 6 weeks of treatment with estrogen alone, estrogen and fluoxetine, or fluoxetine alone

Measure	All Participants n = 0
Value	0

Population analysed: UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable.

Adverse events

Time frame: Entire study duration. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 319772Weissman MM, Klerman GL. Sex differences and the epidemiology of depression. Arch Gen Psychiatry. 1977 Jan;34(1):98-111. doi: 10.1001/archpsyc.1977.01770130100011.
Background: PubMed 1521388Steiner M. Female-specific mood disorders. Clin Obstet Gynecol. 1992 Sep;35(3):599-611. doi: 10.1097/00003081-199209000-00020.
Background: PubMed 8312982Pariser SF. Women and mood disorders. Menarche to menopause. Ann Clin Psychiatry. 1993 Dec;5(4):249-54. doi: 10.3109/10401239309148824.
Background: PubMed 7645647Pearlstein TB. Hormones and depression: what are the facts about premenstrual syndrome, menopause, and hormone replacement therapy? Am J Obstet Gynecol. 1995 Aug;173(2):646-53. doi: 10.1016/0002-9378(95)90297-x.
Background: PubMed 8939110Nicol-Smith L. Causality, menopause, and depression: a critical review of the literature. BMJ. 1996 Nov 16;313(7067):1229-32. doi: 10.1136/bmj.313.7067.1229.
Background: PubMed 2053622Schmidt PJ, Rubinow DR. Menopause-related affective disorders: a justification for further study. Am J Psychiatry. 1991 Jul;148(7):844-52. doi: 10.1176/ajp.148.7.844.
Background: PubMed 8887186Arpels JC. The female brain hypoestrogenic continuum from the premenstrual syndrome to menopause. A hypothesis and review of supporting data. J Reprod Med. 1996 Sep;41(9):633-9.
Background: PubMed 8676707Lopez-Jaramillo P, Teran E, Molina G, Rivera J, Lozano A. Oestrogens and depression. Lancet. 1996 Jul 13;348(9020):135-6. doi: 10.1016/s0140-6736(05)64656-9. No abstract available.
Background: PubMed 1658700Ditkoff EC, Crary WG, Cristo M, Lobo RA. Estrogen improves psychological function in asymptomatic postmenopausal women. Obstet Gynecol. 1991 Dec;78(6):991-5.
Background: PubMed 197385Schneider MA, Brotherton PL, Hailes J. The effect of exogenous oestrogens on depression in menopausal women. Med J Aust. 1977 Jul 30;2(5):162-3. doi: 10.5694/j.1326-5377.1977.tb99116.x.
Background: PubMed 338104Thomson J, Oswald I. Effect of oestrogen on the sleep, mood, and anxiety of menopausal women. Br Med J. 1977 Nov 19;2(6098):1317-9. doi: 10.1136/bmj.2.6098.1317.
Background: PubMed 2848799Berlanga C. Potentiating effect of estrogen in a patient with treatment-resistant depression. J Clin Psychiatry. 1988 Dec;49(12):504. No abstract available.

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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.

Cynthia N Epperson, MD principal investigator

University of Pennsylvania School of Medicine Department of Psychiatry

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 16 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 1 Jun 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. 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?

Yes. Results are posted in the registry (first posted 1 Jun 2017). 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?

Comparison of Cortical GABA Levels in 4 Groups of Subjects Using Estrogen Alone, Fluoxetine Alone, Estrogen and Fluoxetine Combined in Pre and Post 4.0T Magnetic Resonance Spectroscopy Sessions. (time frame: Healthy controls will undergo scans pre and post 3 weeks of estrogen treatment. Women with depression will undergo scans pre and post 6 weeks of treatment with estrogen alone, estrogen and fluoxetine, or fluoxetine alone). 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 NCT00626340, which also lists 21 linked publications.

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 1 Jun 2017.