Clinical trial: The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder (NCT00678574)

Eligibility criteria:
Inclusion Criteria:

          -  Aged 18 - 45 years old and able to give voluntary written informed consent.

          -  Willing to complete a daily log of mood symptoms for 7 consecutive menstrual cycles:
             two menstrual cycles during the Screening Phase (Phase 1), one menstrual cycle during
             the Testing Phase (Phase 2), and four menstrual cycles during the Medication Treatment
             Phase and Post-Treatment Phase (Phase 3). All subjects who successfully complete
             Phases 1 and 2, and the Medication Treatment Phase, will be invited to participate in
             Phase 3 approximately three months later. Phase 3 will involve repeating all
             procedures conducted in Phase 2, including the daily log of mood symptoms.

          -  Meet DSM-IV criteria for premenstrual dysphoric disorder, confirmed by the Daily
             Record of Severity of Problems (DRSP; Endicott & Harrison) for 2 consecutive menstrual
             cycles (Phase 1). The DRSP is a self-rated symptom checklist, which requires
             individuals to rate their symptoms of PMDD according to the DSM-IV research criteria
             scale on a scale from 1 (symptom not present) to 6 (symptom extreme). During the last
             7 days of the menstrual cycle compared to days 5-11, patients must have a 30% increase
             in their average (over 2 menstrual cycles) score for 5 of these 10 symptoms. Symptoms
             must be "not present" or "minimal" during the postmenstrual week.

          -  Average 19-item Hamilton Depression Rating Scale (HAM-D) scores < 5 during the
             follicular phase and > 16 during the luteal phase.

          -  Have regular menstrual cycles 28 to 32 days in length. Each of the screening cycles
             must be ovulatory as confirmed by plasma progesterone levels of >5 ng/ml during the
             luteal phase.

        Exclusion Criteria:

          -  Presence of any other comorbid DSM-IV Axis I disorder.

          -  Meeting DSM-IV criteria for psychoactive substance (excluding nicotine) dependence
             within the preceding 4 months.

          -  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.

          -  Use of anticonvulsant or benzodiazepines within the last month.

          -  Use of psychotropic medication in last week (except as stated above).

          -  Use of steroid contraceptives within the previous 4 months, including birth control
             pill, birth control patch, birth control ring, and Depo-Provera®. Subjects will be
             asked to use abstinence or the barrier method (condoms) as forms of contraception in
             this study.

          -  Alcohol consumption greater than 7 drinks/week.

          -  Current pregnancy.

          -  Metallic implants.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? 0