Brain Imaging Study in Menopausal Women With and Without Major Depressive Disorder
NCT ID: NCT00626340
Last Updated: 2017-06-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
18 participants
INTERVENTIONAL
1999-07-31
2008-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Estrogen and Serotonin on Changing Brain Chemistry
NCT01208324
Estrogen and Perimenopausal Depression
NCT00229450
Perimenopausal Effects of Estradiol on Reward Responsiveness
NCT02255175
The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder
NCT00678574
Perimenopause-Related Mood and Behavioral Disorders
NCT00001231
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MDD diagnosis and Estrogen treatment
Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen alone.
MDD diagnosis and Estrogen treatment
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 treatment
Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone.
MDD diagnosis and Fluoxetine treatment
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 treatment
Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.
MDD diagnosis with both Estrogen and Fluoxetine treatment
Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.
No depression and estrogen treatment
Non-depressed menopausal women between the ages of 40-70 receiving treatment with estrogen alone.
No depression and estrogen treatment
Control participants with no MDD diagnosis received estrogen only for the treatment of physical symptoms of menopause.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MDD diagnosis and Estrogen treatment
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 treatment
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 treatment
Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.
No depression and estrogen treatment
Control participants with no MDD diagnosis received estrogen only for the treatment of physical symptoms of menopause.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
* 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.
Exclusion Criteria
* 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.
* 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.
40 Years
70 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Pennsylvania
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cynthia N Epperson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania School of Medicine Department of Psychiatry
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yale University
New Haven, Connecticut, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Steiner M. Female-specific mood disorders. Clin Obstet Gynecol. 1992 Sep;35(3):599-611. doi: 10.1097/00003081-199209000-00020.
Pariser SF. Women and mood disorders. Menarche to menopause. Ann Clin Psychiatry. 1993 Dec;5(4):249-54. doi: 10.3109/10401239309148824.
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.
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.
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.
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.
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.
Ditkoff EC, Crary WG, Cristo M, Lobo RA. Estrogen improves psychological function in asymptomatic postmenopausal women. Obstet Gynecol. 1991 Dec;78(6):991-5.
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.
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.
Berlanga C. Potentiating effect of estrogen in a patient with treatment-resistant depression. J Clin Psychiatry. 1988 Dec;49(12):504. No abstract available.
Oppenheim G. A case of rapid mood cycling with estrogen: implications for therapy. J Clin Psychiatry. 1984 Jan;45(1):34-5.
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.
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.
Krystal JH, Karper LP, Seibyl JP, Freeman GK, Delaney R, Bremner JD, Heninger GR, Bowers MB Jr, Charney DS. Subanesthetic effects of the noncompetitive NMDA antagonist, ketamine, in humans. Psychotomimetic, perceptual, cognitive, and neuroendocrine responses. Arch Gen Psychiatry. 1994 Mar;51(3):199-214. doi: 10.1001/archpsyc.1994.03950030035004.
Mazure C, Nelson JC, Price LH. Reliability and validity of the symptoms of major depressive illness. Arch Gen Psychiatry. 1986 May;43(5):451-6. doi: 10.1001/archpsyc.1986.01800050053006.
Petty F, Kramer GL, Gullion CM, Rush AJ. Low plasma gamma-aminobutyric acid levels in male patients with depression. Biol Psychiatry. 1992 Aug 15;32(4):354-63. doi: 10.1016/0006-3223(92)90039-3.
Rothman DL, Petroff OA, Behar KL, Mattson RH. Localized 1H NMR measurements of gamma-aminobutyric acid in human brain in vivo. Proc Natl Acad Sci U S A. 1993 Jun 15;90(12):5662-6. doi: 10.1073/pnas.90.12.5662.
Squires RF, Saederup E. Antidepressants and metabolites that block GABAA receptors coupled to 35S-t-butylbicyclophosphorothionate binding sites in rat brain. Brain Res. 1988 Feb 16;441(1-2):15-22. doi: 10.1016/0006-8993(88)91378-9.
Wisner KL, Wheeler SB. Prevention of recurrent postpartum major depression. Hosp Community Psychiatry. 1994 Dec;45(12):1191-6. doi: 10.1176/ps.45.12.1191.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
9907010780
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.