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| Descriptive Information Fields | |||||
| Brief Title † | Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning | ||||
| Official Title † | Effect of Serotonin Reuptake Inhibitors on Gonadal Steroid Hormones | ||||
| Brief 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. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Health Services Research, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment | ||||
| Primary Outcome Measure † | 17-OH-pregnenolone [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Arizona Sexual Experiences Scale (ASEX) [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ] Free testosterone [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ] Estradiol [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ] Prolactin [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ] Progesterone [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ] Dehydroepiandrosterone Sulfate (DHEA-S) [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ] Androstenedione [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ] C-reactive protein [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ] Inflammatory cytokines [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ] Lymphocyte activation markers [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ] |
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| Condition † | Depression | ||||
| Intervention † | Drug: Fluoxetine Drug: Bupropion |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 80 | ||||
| Start Date † | October 2005 | ||||
| Completion Date | September 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00611975 | ||||
| Organization ID | R21 MH071543 | ||||
| Secondary IDs †† | DNBBS 73-MCR | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 2008 | ||||
| First Received Date † | February 6, 2008 | ||||
| Last Updated Date | February 14, 2008 | ||||
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