Gcrc.howard.edu

Reporting period: April 1, 2011-March 31, 2012 Submitted February 29, 2012 by Yvonne Herivaux (212-746-4746).
Review the description of your project. If there have been any changes to the project over the past year, update the description.
    Short project title (< 90 characters):  Androgen Hormones in PMDD
    Full title:  Androgen Hormones in PMDD
    Project summary:  Premenstrual dysphoric disorder is a disabling complex of mood and physical symptoms that
affects 5-8% of premenopausal women. Because symptoms are limited to the luteal phase of themenstrual cycle, fluxes in reproductive hormones during the cycle are thought to precipitatesymptoms. However, the mechanisms through which hormonal fluctuations produce symptoms ofPMDD remain unclear. To date, there has been little study of the role of androgen hormones inPMDD. Although circulating levels of androgen hormones do not rise in the luteal phase, androgenprecursors, including progesterone and pregnenolone, do rise in the luteal phase and can beconverted to androgens in brain and other tissues. Increased sensitivity to locally synthesizedandrogens in women with PMDD could lead to several prominent PMDD symptoms, includingirritability, mood lability, and bloating. In this R34 exploratory treatment development application,we propose to clarify the role of androgen hormones in PMDD by conducting a pilot treatmentefficacy study. The efficacy of a specific androgen receptor antagonist, flutamide, for treatment ofPMDD will be tested in a placebo-controlled study. 64 subjects will be recruited who meetDSM-IV criteria for PMDD, confirmed by two months of prospective daily ratings. Subjects willbe randomized to two months of treatment with either flutamide or placebo. This study will enabledetermination of an effect size for this treatment which is necessary for design of a larger scaleclinical trial, and will also provide data regarding the tolerability of this treatment. If there ispreliminary evidence of efficacy of this anti-androgen treatment, and the treatment is well-tolerated,a full-scale clinical trial will be planned. If the treatment shows evidence of efficacy, but is notwell-tolerated, alternative methods of blocking androgen hormone activity will be investigated.
This study will also provide evidence as to whether androgen hormones, acting through androgenreceptos, play a role in the pathophysiology of PMDD.     Which classification is MOST Clinical or patient-related
applicable to the current project? 
Area of
eRA Commons
Role on Project Department
Institution
Expertise
Username 
Altemus, Margaret 
Engel, Diane 
Kocsis, James H.
Nguyen, Theresa Tran Psychiatry
*If there has been a change in Primary PI on a project, please contact CCTS directly.
Please review the information below, make any necessary corrections, and provide any missing data. When finished editing, click the "Thisinformation is up-to-date" checkbox. Human Subjects 
    Is this a human subjects study?  Yes
    IRB Institution:  Weill Cornell Medical College
    Last IRB Approval:  6/13/2011
    IRB Number (if known):  0404007100
Animal Subjects 
    Is this an animal subjects study?  No
Status of data collection:  Begun
Status of subject accrual:  Begun
PROGRESS REPORT
Briefly describe below any progress on this study since April 1, 2011. Include any interim or final results, subject accrual, and/or other
important developments. Describe any impact the award has made on your research. If there has been no activity on the project, please state this
and describe any barriers encountered (e.g., lack of funding, problems recruiting, etc.). If the study is completed (no further data collection or
analysis) and you believe that there will not be any future publications resulting from this project, state that here with your final progress
report and include the study completion date. Please note that special formatting (tables, figures, etc.) is not supported in this section.
7 subjects were enrolled in the screening phase of the study over the past year, but only one subject met criteria for randomization. Thissubject withdrew during the randomization phase. Recruitment has been difficult due to another ongoing PMDD treatment trial which offerssubject payment and involves no safety laboratory tests and less frequent office visits. After two more subjects complete the randomizationphase, we plan to close enrollment and analyze the results. That should happen by the summer of 2012. The following table lists publications and presentations (if any) on record in the CCTS as resulting from the current project. Date Published or
Cited CCTS
Citation
Presented
Altemus Margaret. Hormone-specific psychiatric disorders: do they exist?. Arch Womens Ment Health 13:25-6, 2010. PMID: 20127449 Altemus M. Comment on “Case 9” re menstrually related mood disorders in The Approach to the Psychiatric Patient, Barnhill, J editor, American Psychiatric Press, The following list includes all grants (both federal and non-federal) in our records for Margaret Altemus.
IMPORTANT NOTE: This page is for GRANTS only; do not include AWARDS here. AWARDS can be entered into the HONORS section ofthe current progress report. Note that an award is given to recognize research and accomplishments that were completed in the past. Awardfunding is less restrictive on its uses. A grant provides funding to complete research in the future. It is more restrictive in how the money canbe spent and requires submission of reports following the research period. (https://www.psichi.org/awards/faqs/awards.aspx). Resulted
Supports
Latest Budget
from this
Application
Granting Organization/Grant
Grant Number
Supported
Dates and
this CCTS
Total Funds
Project 
Received
Program 
National Center for Research
Resources (NCRR)
Science Center (UL1) (supplement) National Institute of Mental
Health (NIMH)
National Institute of Mental
Health (NIMH)
National Institute of Mental
Health (NIMH)
National Institute of Mental
Health (NIMH)
Stress in Adolescent Pregnancy:Perinatal Outcomes National Institute of Mental
Health (NIMH)
National Institute of Mental
Health (NIMH)
The list below includes all honors and awards (other than grants) in our records for Margaret Altemus.
Dollar Amount
Date Received
Description
(if applicable)

Source: http://www.gcrc.howard.edu/webcamp/sourcecode/WebCAMP_ProgressReports/NoLogin/Report79.pdf