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According to the National Institute of Mental Health, depressive disorders afflict over six million U.S. men annually. Most cases of moderate or severe depression are treated with antidepressants, including monoamine oxidase inhibitors, tricyclic antidepressants, and, more recently, selective serotonin reuptake inhibitors (SSRIs) and antidepressants with modest serotonin and norepinephrine reuptake inhibition but unknown mechanism-of-action. Over the past two years, prescribing data show a steady increase in antidepressant dispensing rates (especially including serotonin reuptake inhibitors) for adults. SSRIs are known to have an effect on ejaculatory function and are therapeutically used for treatment of premature (rapid) ejaculation. However, few studies have evaluated the potential impact of antidepressant medications on male fertility, and no studies have been published with respect to the impact of newer antidepressants, such as SSRIs, on male fertility. In the high-volume male infertility practice at New York Hospital-Cornell Medical Center, several patients have presented who have had a clear temporal association between SSRI use and impairment in sperm motility and/or sperm transport (emission). These men have shown improvement in sperm counts and motility after discontinuation of antidepressant medications.
We propose a crossover pilot study of normal healthy males to ascertain possible effects of SSRIs on semen parameters. After initial screening semen analyses, subjects will take the SSRI paroxetine for five weeks. Serial semen analyses will be obtained while on medication and one month after discontinuation of medication. Comparisons between semen parameters on and off medication will be used to evaluate the frequency and significance of semen analysis changes during SSRI treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paroxetine | Drug | paroxetine 10-40mg daily x 5 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Semen Volume | measured in mL | 2 months post initial visit |
| Sperm Concentration | number of sperm per cubic centimeter of semen | 2 months post initial visit |
| Sperm Motility | percent of sperm with movement | 2 months post initial visit |
| Sperm Morphology | percent of sperm with normal shape | 2 months post initial visit |
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Inclusion Criteria:
Exclusion Criteria:
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community sample
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| Name | Affiliation | Role |
|---|---|---|
| Peter N. Schlegel, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Weill Medical College of Cornell University | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paroxetine | Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paroxetine | Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Semen Volume | measured in mL | Posted | Mean | Standard Deviation | mL | 2 months post initial visit |
|
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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 | Paroxetine | Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Side effect to medication | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter N Schlegel, MD | Weill Cornell Medical College | 2127465491 | pnschleg@med.cornell.edu |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| D017367 | Selective Serotonin Reuptake Inhibitors |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014179 | Neurotransmitter Uptake Inhibitors |
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Serum samples Semen samples
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Primary | Sperm Concentration | number of sperm per cubic centimeter of semen | Posted | Mean | Standard Deviation | number of sperm per cubic centimeter | 2 months post initial visit |
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| Primary | Sperm Motility | percent of sperm with movement | Posted | Mean | Standard Deviation | Percent of sperm with movement | 2 months post initial visit |
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| Primary | Sperm Morphology | percent of sperm with normal shape | Posted | Mean | Standard Deviation | percent of sperm with normal shape | 2 months post initial visit |
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| 0 |
| 33 |
| 1 |
| 33 |
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| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |
| D045505 | Physiological Effects of Drugs |