The investigators are conducting a placebo-controlled, randomized control trial with duloxetine in healthy, fertile men not previously on any antidepressants. Participants will be randomized to either the duloxetine or placebo groups for 6 weeks. The investigators will assess changes in sperm DNA fragmentation at 0, 2, 6, 8, and 10 weeks. Other outcomes measured will include semen parameters (sperm concentration, motility, morphology), hormone levels (testosterone, estrogen, prolactin, LH, FSH), and sexual function (IIEF and MSHQ) surveys.
Antidepressant medications are commonly prescribed in the USA not only for depression, but also for anxiety disorders such as generalized anxiety disorder and obsessive-compulsive disorder, premature ejaculation, post-traumatic stress disorder, and neuropathic pain. Despite being widely prescribed in the United States in men of reproductive age, the impact of antidepressants on fertility has not been extensively studied. After noticing worsened semen parameters in men on anti-depressants, the investigators performed the first prospective study to demonstrate a deleterious impact of selective serotonin reuptake inhibitors (SSRI) on sperm DNA integrity, which has been linked to reproductive outcomes. Further small studies have corroborated the negative impact of SSRIs on male fertility, as assessed by semen parameters and/or sperm DNA integrity. No studies have examined the impact of a newer, but similar, class of antidepressant - the serotonin-norepinephrine reuptake inhibitor (SNRI). Like SSRIs, SNRIs inhibit the reuptake of serotonin, but also act on norepinephrine. The use of SNRIs has increased recently due to their slightly improved efficacy profile when compared to SSRIs. Duloxetine is an SNRI and is one of the most commonly prescribed anti-depressants in the United States. The investigators are conducting this trial to determine whether or not the administration of duloxetine will result in a deterioration in sperm DNA fragmentation in healthy, fertile men.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week
Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Weill Cornell Medicine
New York, New York, United States
Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks
Number of participants with TUNEL values \> 25% at 6 weeks in each treatment group
Time frame: 6 Weeks (primary time point of interest)
Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks
Number of participants with Tunel Values \> 25% at 0 Weeks (baseline) in each treatment group
Time frame: 0 weeks
Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks
Number of participants with Tunel values \> 25% at 2 weeks in each treatment group
Time frame: 2 weeks
Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks
Number of participants with Tunel values \> 25% at 8 weeks in each treatment group
Time frame: 8 weeks
Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks
Number of participants with Tunel values \> 25% at 10 weeks in each treatment group
Time frame: 10 Weeks
Sperm Concentration at 0 Weeks
Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks
Time frame: 0 weeks
Sperm Concentration at 2 Weeks
Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks
Time frame: 2 weeks
Sperm Concentration at 6 Weeks
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Enrollment
69
Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks
Time frame: 6 weeks
Sperm Concentration at 8 Weeks
Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks
Time frame: 8 weeks
Sperm Concentration at 10 Weeks
Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks
Time frame: 10 Weeks
Sperm Motility at 0 Weeks
Sperm motility (mean percent) at 0 weeks
Time frame: 0 weeks
Sperm Motility at 2 Weeks
Sperm motility (mean percent) at 2 weeks
Time frame: 2 weeks
Sperm Motility at 6 Weeks
Sperm motility (mean percent) at 6 weeks
Time frame: 6 weeks
Sperm Motility at 8 Weeks
Sperm motility (mean percent) at 8 weeks
Time frame: 8 weeks
Sperm Motility at 10 Weeks
Sperm motility (mean percent) at 10 weeks
Time frame: 10 Weeks
Sperm Head Defects at 0 Weeks
Sperm head defects (mean number) at 0 weeks
Time frame: 0 weeks
Sperm Head Defects at 2 Weeks
Sperm head defects (mean number) at 2 weeks
Time frame: 2 weeks
Sperm Head Defects at 6 Weeks
Sperm head defects (mean number) at 6 weeks
Time frame: 6 weeks
Sperm Head Defects at 8 Weeks
Sperm head defects (mean number) at 8 weeks
Time frame: 8 weeks
Sperm Head Defects at 10 Weeks
Sperm head defects (mean number) at 10 weeks
Time frame: 10 Weeks
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Time frame: 0 weeks
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Time frame: 2 weeks
Sperm Neck Defects at 6 Weeks
Sperm neck defects (mean number) at 6 weeks
Time frame: 6 weeks
Sperm Neck Defects at 8 Weeks
Sperm neck defects (mean number) at 8 weeks
Time frame: 8 weeks
Sperm Neck Defects at 10 Weeks
Sperm neck defects (mean number) at 10 weeks
Time frame: 10 Weeks
Sperm Tail Defects at 0 Weeks
Sperm tail defects (mean number) at 0 weeks
Time frame: 0 weeks
Sperm Tail Defects at 2 Weeks
Sperm tail defects (mean number) at 2 weeks
Time frame: 2 weeks
Sperm Tail Defects at 6 Weeks
Sperm tail defects (mean number) at 6 weeks
Time frame: 6 weeks
Sperm Tail Defects at 8 Weeks
Sperm tail defects (mean number) at 8 weeks
Time frame: 8 weeks
Sperm Tail Defects at 10 Weeks
Sperm tail defects (mean number) at 10 weeks
Time frame: 10 Weeks
Testosterone Level at 0 Weeks
Testosterone level (ng/dL) at 0 weeks
Time frame: 0 weeks
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Testosterone level (ng/dL) at 2 weeks
Time frame: 2 weeks
Testosterone Level at 6 Weeks
Testosterone level (ng/dL) at 6 weeks
Time frame: 6 weeks
Testosterone Level at 8 Weeks
Testosterone level (ng/dL) at 8 weeks
Time frame: 8 weeks
Testosterone Level at 10 Weeks
Testosterone level (ng/dL) at 10 weeks
Time frame: 10 Weeks
Estrogen Level at 0 Weeks
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Time frame: 0 weeks
Estrogen Level at 2 Weeks
Estrogen level (pg/mL) at 2 weeks
Time frame: 2 weeks
Estrogen Level at 6 Weeks
Estrogen level (pg/mL) at 6 weeks
Time frame: 6 weeks
Estrogen Level at 8 Weeks
Estrogen level (pg/mL) at 8 weeks
Time frame: 8 weeks
Estrogen Level at 10 Weeks
Estrogen level (pg/mL) at 10 weeks
Time frame: 10 Weeks
Prolactin Level at 0 Weeks
Prolactin level (ng/mL) at 0 weeks
Time frame: 0 weeks
Prolactin Level at 2 Weeks
Prolactin level (ng/mL) at 2 weeks
Time frame: 2 weeks
Prolactin Level at 6 Weeks
Prolactin level (ng/mL) at 6 weeks
Time frame: 6 weeks
Prolactin Level at 8 Weeks
Prolactin level (ng/mL) at 8 weeks
Time frame: 8 weeks
Prolactin Level at 10 Weeks
Prolactin level (ng/mL) at 10 weeks
Time frame: 10 Weeks
Luteinizing Hormone Level at 0 Weeks
Luteinizing hormone level (mIU/mL) at 0 weeks
Time frame: 0 weeks
Luteinizing Hormone Level at 2 Weeks
Luteinizing hormone level (mIU/mL) at 2 weeks
Time frame: 2 weeks
Luteinizing Hormone Level at 6 Weeks
Luteinizing hormone level (mIU/mL) at 6 weeks
Time frame: 6 weeks
Luteinizing Hormone Level at 8 Weeks
Luteinizing hormone level (mIU/mL) at 8 weeks
Time frame: 8 weeks
Luteinizing Hormone Level at 10 Weeks
Luteinizing hormone level (mIU/mL) at 10 weeks
Time frame: 10 Weeks
Follicle Stimulating Hormone Level at 0 Weeks
Follicle stimulating hormone level (mIU/mL) at 0 weeks
Time frame: 0 weeks
Follicle Stimulating Hormone Level at 2 Weeks
Follicle stimulating hormone level (mIU/mL) at 2 weeks
Time frame: 2 weeks
Follicle Stimulating Hormone Level at 6 Weeks
Follicle stimulating hormone level (mIU/mL) at 6 weeks
Time frame: 6 weeks
Follicle Stimulating Hormone Level at 8 Weeks
Follicle stimulating hormone level (mIU/mL) at 8 weeks
Time frame: 8 weeks
Follicle Stimulating Hormone Level at 10 Weeks
Follicle stimulating hormone level (mIU/mL) at 10 weeks
Time frame: 10 Weeks