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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00611975 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Fluoxetine Drug: Bupropion |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Health Services Research |
| Official Title: | Effect of Serotonin Reuptake Inhibitors on Gonadal Steroid Hormones |
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | September 2008 |
| Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Participants will receive treatment with fluoxetine for 2 months
|
Drug: Fluoxetine
Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine.
Other Name: Prozac, Serafem
|
|
Experimental: B
Participants will receive treatment with bupropion for 2 months
|
Drug: Bupropion
Participants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion.
Other Name: Wellbutrin, Zyban
|
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| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| New York Presbyterian Hospital Weill Cornell Medical College | |
| New York, New York, United States, 10065 | |
| Principal Investigator: | Margaret Altemus, MD | Weill Medical College of Cornell University |
More Information
| Responsible Party: | Margaret Altemus, MD, Weill Medical College, Cornell University |
| ClinicalTrials.gov Identifier: | NCT00611975 History of Changes |
| Other Study ID Numbers: | R21 MH071543, DNBBS 73-MCR |
| Study First Received: | February 6, 2008 |
| Last Updated: | August 11, 2011 |
| Health Authority: | United States: Federal Government |
|
Gonadal Steroid Hormones Healthy Volunteers Antidepressant Side Effects Fluoxetine Bupropion Prolactin |
Testosterone Estradiol Progesterone Sexual Function Serotonin Reuptake Inhibitors 17-OH Pregnenolone |
|
Antidepressive Agents Fluoxetine Bupropion Serotonin Uptake Inhibitors Hormones Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Hormones, Hormone Substitutes, and Hormone Antagonists Dopamine Uptake Inhibitors Dopamine Agents |
