Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Fluoxetine (Drug); Bupropion (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
Margaret Altemus, MD, Principal Investigator, Affiliation: Weill Cornell Medical College
Overall contact:
Diane Engel, LMSW, Phone: 212-746-3759, Email: die2001@med.cornell.edu
Summary
This study will evaluate the effect of antidepressants on sex hormone levels in women and if
the potential changes in sex hormone levels are related to sexual side effects.
Clinical Details
Official title: Effect of Serotonin Reuptake Inhibitors on Gonadal Steroid Hormones
Study design: Health Services Research, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Primary outcome: 17-OH-pregnenolone
Secondary outcome: Arizona Sexual Experiences Scale (ASEX)Free testosterone Estradiol Prolactin Progesterone Dehydroepiandrosterone Sulfate (DHEA-S) Androstenedione C-reactive protein Inflammatory cytokines Lymphocyte activation markers
Detailed description:
Depression is a leading cause of disability in women, with women being two times more likely
than men to develop depression. Depression affects a person's body, thoughts, mood, and
behavior, often making normal day-to-day functioning difficult. Fortunately, depression is a
condition that is highly treatable with one or more of the antidepressant medications and
forms of psychotherapy available. Serotonin reuptake inhibitors (SRIs) are a recent class of
antidepressants that have been successful in alleviating symptoms of depression. Although the
side effects of SRIs are less than those of other types of antidepressants, a number of
people taking SRIs experience sexual dysfunction, including reduced desire and difficulty
with orgasm. It is believed that SRI treatment may interfere with gonadal production of
steroid hormones, thus leading to changes in sexual function. This study will compare the
effects of the SRI fluoxetine with the effects of the non-SRI bupropion on circulating levels
of sex hormones in healthy women and on any related sexual side effects.
Participation in this study will last 3 months. Potential participants will undergo initial
screening, which will involve a blood draw, drug and pregnancy tests, physical exam,
electrocardiogram, and psychiatric diagnostic interview. Participants will also complete an
interview and questionnaire about sexual functioning. All eligible participants will then be
asked to return for a total of 9 study visits over 3 months.
Participants will undergo 1 month of baseline hormonal sampling and 2 months of daily
treatment with either fluoxetine or bupropion. The study visits will be scheduled around
three points in the menstrual cycle (early follicular, ovulatory, and luteal), with each
visit including a blood draw and repeat questionnaire on sexual functioning. Participants
will be asked to perform daily urine tests, beginning 10 days after the start of menstruation
and continuing for up to 8 days until detection of the luteinizing hormone surge, which
signals ovulation. Participants will be asked to keep a diary of luteinizing hormone surges,
dates of menstruation, and sexual activities. At the Month 3 visit, participants will
discontinue their assigned medication and will complete their final blood draw and
questionnaire.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Regular menstrual cycles that are 25 to 35 days in length during the 1 year prior to
study entry
- Willing to engage in sexual activity, alone or with a partner, at least weekly for the
duration of the study
- Willing to use effective birth control (e. g., condom, diaphragm with spermicide, tubal
ligation, nonhormonal IUD, partner with vasectomy) for the duration of the study
Exclusion Criteria:
- Medical illness that may contribute to sexual dysfunction or affect steroid hormone
levels
- Body mass index (BMI) greater than 30
- Elevated testosterone at screening
- History of seizure disorder
- Consumes more than 10 alcoholic beverages per week
Locations and Contacts
Diane Engel, LMSW, Phone: 212-746-3759, Email: die2001@med.cornell.edu
New York Presbyterian Hospital Weill Cornell Medical College, New York, New York 10065, United States; Recruiting
Theresa Nguyen, NP, Sub-Investigator
Additional Information
Starting date: October 2005
Ending date: September 2008
Last updated: February 14, 2008
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