Impact of Oral Contraceptives on GABA and Neurosteroids
Information source: Yale University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: oral contraceptive pill (Other)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s):
C. Neill Epperson, M.D., Principal Investigator, Affiliation: Yale University School of Medicine Department of Psychiatry
Summary
The purpose of this study is to investigate the effect of oral contraceptive pills (OCPs) on
cortical GABA concentrations as measured by proton magnetic resonance spectroscopy (1H-MRS)
in non-depressed, healthy menstruating women. A secondary aim is to determine the impact of
OCP use on plasma and cerebral spinal fluid (CSF) levels of estradiol (E2) and progesterone,
as well as neurosteroids such as pregnenolone, allopregnanolone, pregnanolone and 5
alpha-dihydroprogesterone (5α-DHP). We will assess the impact of OCPs on mood, controlling
for previous history of affective disorders (excepting bipolar affective disorder or major
depressive disorder with psychotic features). Mood symptoms will be measured throughout the
study using the Daily Record of Severity of Problems (DRSP; Endicott & Harrison, 1990;
Endicott et al., 2006), a self-rated symptom checklist.
Clinical Details
Official title: Impact of Oral Contraceptives on GABA and Neurosteroids
Study design: Cohort, Prospective
Primary outcome: The purpose of this study is to investigate the effect of oral contraceptive pills (OCPs) on cortical GABA concentrations as measured by proton magnetic resonance spectroscopy (1H-MRS) in non-depressed, healthy menstruating women.
Secondary outcome: To determine the impact of OCP use on plasma and cerebral spinal fluid (CSF) levels of estradiol (E2) and progesterone, as well as neurosteroids such as pregnenolone, allopregnanolone, pregnanolone and 5 alpha-dihydroprogesterone (5α-DHP).
Eligibility
Minimum age: 18 Years.
Maximum age: 42 Years.
Gender(s): Female.
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 5 consecutive menstrual cycles.
- Be either taking a combined OCP for at least 3 months (Group 1), or 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 (Group 2).
- If Group 1, willing to stop OCP and use alternative non-steroidal birth control for up
to 6 months.
- If Group 2, provide documentation of a normal PAP smear, pelvic and breast examination
within the previous 12 months.
- If Group 2, 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 >3
ng/ml during the luteal phase.
- Negative pregnancy blood test at admission; negative urine pregnancy test on each 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)
Locations and Contacts
Yale University School of Medicine; Yale Program for Women's Reproductive Behavioral Health, New Haven, Connecticut 06511, United States
Additional Information
Starting date: January 2007
Ending date: December 2011
Last updated: April 10, 2008
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