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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH071543 | U.S. NIH Grant/Contract | View source | |
| DNBBS 73-MCR |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Participants will receive treatment with fluoxetine for 2 months |
|
| B | Experimental | Participants will receive treatment with bupropion for 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 17-OH Pregnenolone | Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Effects of the two antidepressant treatments and menstrual cycle on hormone level were examined. | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Arizona Sexual Experiences Scale (ASEX) | A five-item scale with each item scored from 1 to 6. Score range is 5 to 30. Higher scores indicate more sexual dysfunction. Scores at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on ASEX scores were examined. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Altemus, MD | Weill Medical College of Cornell University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluoxetine | Participants will receive treatment with fluoxetine for 2 months 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. |
| FG001 | Bupropion | Participants will receive treatment with bupropion for 2 months 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluoxetine | Participants will receive treatment with fluoxetine for 2 months 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in 17-OH Pregnenolone | Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Effects of the two antidepressant treatments and menstrual cycle on hormone level were examined. | All subjects enrolled were included in the mixed model analysis. For mean results at each timepoint in the data table below, some subjects were not included due to missing blood samples or samples collected outside the specified cycle phase window. | Posted | Mean | Standard Error | ng/dl | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
|
Each subject was assessed for 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluoxetine | Participants will receive treatment with fluoxetine for 2 months 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| seizure | Nervous system disorders | SNOWMED CT | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| reduced orgasm | Reproductive system and breast disorders | SNOWMED CT | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Altemus | Yale School of Medicine | 646-209-6277 | margaret.altemus@yale.edu |
| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011427 | Propiophenones |
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|
|
| Bupropion | Drug | 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. |
|
|
| Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
| Change in Free Testosterone | Free testosterone was calculated from total testosterone ng/ml divided by sex hormone binding globulin (SHBG) nmol/l multiplied by 100. Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined. | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
| Change in Estradiol | Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined. | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
| Change in Prolactin | Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined. | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
| Change in Progesterone | Hormone levels at early follicular, ovulation, and luteal phase of the cycle were averaged for the baseline pre-treatment month and compared to average values during the 1st and 2nd months of antidepressant treatment. | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
| Change in Dehydroepiandrosterone Sulfate (DHEA-S) | Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined. | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
| Change in Androstenedione | Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined. | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
| C-reactive Protein | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
| Inflammatory Cytokines | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
| Lymphocyte Activation Markers | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
| BG001 | Bupropion | Participants will receive treatment with bupropion for 2 months 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Bupropion | Participants will receive treatment with bupropion for 2 months 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. |
|
|
|
| Secondary | Change in Arizona Sexual Experiences Scale (ASEX) | A five-item scale with each item scored from 1 to 6. Score range is 5 to 30. Higher scores indicate more sexual dysfunction. Scores at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on ASEX scores were examined. | All subjects enrolled were included in the mixed model analysis. For mean results at each timepoint in the data table below, some subjects were not included due to missing questionnaire samples or samples collected outside the specified cycle phase window. | Posted | Mean | Standard Error | score on a scale | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
|
|
|
|
| Secondary | Change in Free Testosterone | Free testosterone was calculated from total testosterone ng/ml divided by sex hormone binding globulin (SHBG) nmol/l multiplied by 100. Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined. | All subjects enrolled were included in the mixed model analysis. For mean results at each timepoint in the data table below, some subjects were not included due to missing blood samples or samples collected outside the specified cycle phase window. | Posted | Mean | Standard Error | calculated ratio | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
|
|
|
|
| Secondary | Change in Estradiol | Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined. | All subjects enrolled were included in the mixed model analysis. For mean results at each timepoint in the data table below, some subjects were not included due to missing blood samples or samples collected outside the specified cycle phase window. | Posted | Mean | Standard Error | pg/ml | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
|
|
|
|
| Secondary | Change in Prolactin | Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined. | All subjects enrolled were included in the mixed model analysis. For mean results at each timepoint in the data table below, some subjects were not included due to missing blood samples or samples collected outside the specified cycle phase window. | Posted | Mean | Standard Error | ng/ml | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
|
|
|
|
| Secondary | Change in Progesterone | Hormone levels at early follicular, ovulation, and luteal phase of the cycle were averaged for the baseline pre-treatment month and compared to average values during the 1st and 2nd months of antidepressant treatment. | All subjects enrolled were included in the mixed model analysis. For mean results at each timepoint in the data table below, some subjects were not included due to missing blood samples or samples collected outside the specified cycle phase window. | Posted | Mean | Standard Error | ng/ml | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
|
|
|
|
| Secondary | Change in Dehydroepiandrosterone Sulfate (DHEA-S) | Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined. | All subjects enrolled were included in the mixed model analysis. For mean results at each timepoint in the data table below, some subjects were not included due to missing blood samples or samples collected outside the specified cycle phase window. | Posted | Mean | Standard Error | ug/ml | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
|
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|
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| Secondary | Change in Androstenedione | Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined. | All subjects enrolled were included in the mixed model analysis. For mean results at each timepoint in the data table below, some subjects were not included due to missing blood samples or samples collected outside the specified cycle phase window. | Posted | Mean | Standard Error | ng/ml | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
|
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| Secondary | C-reactive Protein | This measure was not performed due to lack of anticipated supplementary funding. | Posted | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
|
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| Secondary | Inflammatory Cytokines | This measure was not performed due to lack of anticipated supplementary funding. | Posted | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
|
|
| Secondary | Lymphocyte Activation Markers | This measure was not performed due to lack of anticipated supplementary funding. | Posted | Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles |
|
|
| 0 |
| 45 |
| 1 |
| 45 |
| 33 |
| 45 |
| EG001 | Bupropion | Participants will receive treatment with bupropion for 2 months 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. | 0 | 38 | 2 | 38 | 21 | 38 |
| pregnancy | Pregnancy, puerperium and perinatal conditions | SNOWMED CT | Non-systematic Assessment |
|
| reduced libido | Reproductive system and breast disorders | SNOWMED CT | Non-systematic Assessment |
|
| reduced appetite | Gastrointestinal disorders | SNOWMED CT | Non-systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | SNOWMED CT | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | SNOWMED CT | Non-systematic Assessment |
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| yawning | Nervous system disorders | SNOWMED CT | Non-systematic Assessment |
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| diarrhea | Gastrointestinal disorders | SNOWMED CT | Non-systematic Assessment |
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| fatigue | General disorders | SNOWMED CT | Non-systematic Assessment |
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| headache | Nervous system disorders | SNOWMED CT | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | SNOWMED CT | Non-systematic Assessment |
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| insomnia | General disorders | SNOWMED CT | Non-systematic Assessment |
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| tinnitus | Nervous system disorders | SNOWMED CT | Non-systematic Assessment |
|
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| D007659 |
| Ketones |
| Baseline month ovulation |
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| Baseline month luteal |
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| Treatment month 1 follicular |
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| Treatment month 1 ovulation |
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| Treatment month 1 luteal |
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| Treatment month 2 follicular |
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| Treatment month 2 ovulation |
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| Treatment month 2 luteal |
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This secondary analysis examined main effect of menstrual cycle phase on ASEX scores |
| Mixed Models Analysis |
| >0.6 |
| Superiority or Other (legacy) |
| Baseline month ovulation |
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| Baseline month luteal |
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| Treatment month 1 follicular |
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| Treatment month 1 ovulation |
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| Treatment month 1 luteal |
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| Treatment month 2 follicular |
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| Treatment month 2 ovulation |
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| Treatment month 2 luteal |
|
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This secondary analysis examined main effect of menstrual cycle phase on hormone levels |
| Mixed Models Analysis |
| <0.01 |
| Superiority or Other (legacy) |
| Baseline month ovulation |
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| Baseline Month Luteal |
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| Treatment month 1 follicular |
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| Treatment month 1 ovulation |
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| Treatment month 1 luteal |
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| Treatment month 2 follicular |
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| Treatment month 2 ovulation |
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| Treatment month 2 luteal |
|
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This secondary analysis examined main effect of menstrual cycle phase on hormone levels |
| Mixed Models Analysis |
| <.0001 |
| Superiority or Other (legacy) |
| Baseline month ovulation |
|
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| Baseline month luteal |
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| Treatment month 1 follicular |
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| Treatment month 1 ovulation |
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| Treatment month 1 luteal |
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| Treatment month 2 follicular |
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| Treatment month 2 ovulation |
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| Treatment month 2 luteal |
|
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This secondary analysis examined main effect of menstrual cycle phase on hormone levels |
| Mixed Models Analysis |
| <.0001 |
| Superiority or Other (legacy) |
| Baseline month ovulation |
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| Baseline month luteal |
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| Treatment month 1 follicular |
|
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| Treatment month 1 ovulation |
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| Treatment month 1 luteal |
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| Treatment month 2 follicular |
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| Treatment month 2 ovulation |
|
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| Treatment month 2 luteal |
|
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This secondary analysis examined main effect of menstrual cycle phase on hormone levels |
| Mixed Models Analysis |
| <.0001 |
| Superiority or Other (legacy) |
| Baseline month ovulation |
|
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| Baseline month luteal |
|
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| Treatment month 1 follicular |
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| Treatment month 1 ovulation |
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| Treatment month 1 luteal |
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| Treatment month 2 follicular |
|
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| Treatment month 2 ovulation |
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| Treatment month 2 luteal |
|
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This secondary analysis examined main effect of menstrual cycle phase on hormone levels |
| Mixed Models Analysis |
| >0.9 |
| Superiority or Other (legacy) |
| Baseline month ovulation |
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| Baseline month luteal |
|
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| Treatment month 1 follicular |
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| Treatment month 1 ovulation |
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| Treatment month 1 luteal |
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| Treatment month 2 follicular |
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| Treatment month 2 ovulation |
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| Treatment month 2 luteal |
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This secondary analysis examined main effect of menstrual cycle phase on hormone levels |
| Mixed Models Analysis |
| >0.7 |
| Superiority or Other (legacy) |