Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning - Full Text View

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
Depression	Drug: Fluoxetine Drug: Bupropion	Phase IV

MedlinePlus related topics:

Depression

ChemIDplus related topics:

Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Fluoxetine Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Progesterone Bupropion hydrochloride Bupropion Fluoxetine hydrochloride Serotonin Pregnenolone Prolactin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment

Official Title:	Effect of Serotonin Reuptake Inhibitors on Gonadal Steroid Hormones

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

17-OH-pregnenolone [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

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
A: Experimental 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.
B: Experimental 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.

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

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611975

Contacts


Contact: Diane Engel, LMSW	212-746-3759	die2001@med.cornell.edu

Locations


United States, New York
	New York Presbyterian Hospital Weill Cornell Medical College	Recruiting
	New York, New York, United States, 10065
	Sub-Investigator: Theresa Nguyen, NP

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Margaret Altemus, MD	Weill Cornell Medical College

More Information

Responsible Party:	Weill Medical College, Cornell University ( Margaret Altemus, MD )
Study ID Numbers:	R21 MH071543, DNBBS 73-MCR
First Received:	February 6, 2008
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00611975
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Gonadal Steroid Hormones

Healthy Volunteers

Antidepressant Side Effects

Fluoxetine

Bupropion

Prolactin

Testosterone

Estradiol

Progesterone

Sexual Function

Serotonin Reuptake Inhibitors

17-OH Pregnenolone

Study placed in the following topic categories:

Depression

Progesterone

Estradiol valerate

Healthy

Methyltestosterone

Estradiol 17 beta-cypionate

Depressive Disorder

Serotonin

Estradiol

Testosterone 17 beta-cypionate

Fluoxetine

Testosterone

Dopamine

Estradiol 3-benzoate

Bupropion

Polyestradiol phosphate

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Serotonin Uptake Inhibitors

Pharmacologic Actions

Behavioral Symptoms

Serotonin Agents

Therapeutic Uses

Dopamine Agents

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on May 15, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00611975