Dysphoric Disorder: The Role of Serotonin and GABA in Premenstrual Dysphoric Disorder

Contact name: Kathryn

Phone: (203)-764-9934

Fax: (0)-0-0

Email: kathryn.czarkowski@yale.edu

Disorder: Premenstrual Dysphoric Disorder (PMDD)

Geographic location: Connecticut - New Haven, Fairfield, & Middlesex Counties

Other keywords: PMS, PMDD, premenstrual dysphoric disorder, hormones, GABA, brain imaging

Participant compensation: Qualifying participants can earn up to $3140.00

Time commitment required: 1-Year

Drug trial: No

Recruitment end date (approximate): 12/21/06

Study criteria (i.e., age or gender requirements):
1. Aged 18-45 and able to give voluntary written informed consent
2. Willing to complete a daily log of mood symptoms for at least 7 consecutive menstrual cycles, and up to12 consecutive menstrual cycles if meet criteria for both studies
3. Meet criteria for PMDD, confirmed by daily log of mood symptoms, during 2 month screening process
4. Have regular menstrual cycles 24-36 days in length
5. Completion of 1st study and taking fluoxetine, sertraline, or paroxetine for PMDD in order to be eligible for participation in 2nd study at month 8
6. Negative blood pregnancy test at admission, and negative urine pregnancy tests duing each test session occuring during months 8-12
7. Must be willing to abstain from alcohol consumption for one week prior to each of the 4 test sessions occuring between months 8-12

Exclusion criteria:
1. Meet criteria for another psychiatric illness in addition to PMDD
2. Meet criteria for substance abuse/dependence within the preceeding 4 months (this includes nicotine) prior to participation in study #1
3. A 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
4. Use of psychiatric medication within the previous 4 months prior to enrollment in the 1st study
5. Use of steroid contraceptives within the previous 4 months prior to enrollment in the 1st study, including birth control pills, birth contral patch, birth control ring, and Depo-ProveraŽ
6. Alcohol consumption greater than 7 drinks per week
7. Current pregnancy
8. Metallic Implants
9. For study #2, current treatment with psychoactive medication other than fluoxetine, sertraline, or paroxetine
10. Diabetes controlled by means other than diet
11. For study #2, lactose intolerance as defined by severe stomach cramping and diarrhea caused by eating more than a usual serving of dairy products
12. History of claustrophic symptoms

Brief description of study:
Potential participants who suffer from moderate to severe symptoms of premenstrual syndrome (i.e., mood swings, irritability, anxiety, tearfulness/crying, sleep disturbance, decreased interest/pleasure in normal activities) 4-10 days prior to menses each month are invited to contact Women's Reproductive Behavioral Health (WRBH) at Yale University. Eligible participants will participate in a 7-month study involving brain imaging & treatment with fluoxetine. Spinal taps are optional. This study is examining the relationship between hormones, mood, and fluctuations in GABA (study #1). Participants participate in 6 test sessions. Upon completion of this study, participants who remain in treatment with WRBH will be eligibile to participate in a 2nd study examining the role of serotonin and GABA in the treatment of PMDD. Study #2 is 5-months long and involves four testing days spread out over 4 months. Two of the 4 testing days involves an all day test at Yale-New Haven Hospital. This study also involves brain imaging.

Additional information:
The Yale Program for Women's Reproductive Behavioral Health is a women's clinical research program examining the role of hormones, mood, and cognition in various mood disorders occurring throughout the reproductive life-cycle. For additional information, please go to our website: www.research4women.org