Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT00656318
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 - 42 years old and able to give voluntary written informed consent.
* Willing to complete a daily log of mood symptoms for 3 consecutive menstrual cycles.
* Be off of OCPs for at least 3 menstrual periods prior to beginning the study and be willing to go on OCPs for the study.
* Provide documentation of a normal PAP smear, pelvic and breast examination within the previous 12 months prior to enrollment.
* Have regular menstrual cycles 28 to 32 days in length prior to enrollment. The screening cycle must be ovulatory as confirmed by plasma progesterone levels of \>3 ng/ml during the luteal phase.
* Negative pregnancy blood test at admission; negative urine pregnancy test on the MRS testing day.
Exclusion Criteria:
* Presence of any DSM-IV Axis I disorder, excepting possible mild to moderate PMS/PMDD, within the previous 12 months.
* Lifetime history of any psychotic disorder, including bipolar disorder.
* Meeting DSM-IV criteria for psychoactive substance (including nicotine) abuse/dependence within the preceding 6 months.
* A history of serious medical or neurological illness, including (but not limited to) major cardiovascular disease, hypertension (SBP \> 140 mm Hg and DBP \> 90 mm Hg), intracranial mass lesions, seizure disorder, severe hepatic or renal disease, unstable endocrine or metabolic disease, unstable hematologic disease, gynecologic cancer and gallbladder disease, venous thromboembolism, and stroke.
* Diabetes if present with one other cardiovascular risk factor such as hypercholesterolemia or hypertension.
* Hypercholesterolemia if LDL \> 160 mg/dl.
* Use of any psychotropic medication within the previous month.
* Alcohol consumption greater than 7 drinks/week.
* Current pregnancy or planning to become pregnant during the course of the study.
* Metallic implants.
* History of or suspected claustrophobias.
* Migraine headaches if \> 35 yo.
* Weigh \>300 lbs (the 4T magnet has a weight limit \<300 lbs)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
42 Years
Study:
NCT00656318
Study Brief:
Protocol Section:
NCT00656318