Impact of Escitalopram on Sperm DNA Fragmentation

Weill Cornell Medicine (WCM)

Status and phase: Enrolling; Phase 2

Conditions: Sperm DNA Fragmentation; Infertility, Male

Treatments: Other: Placebo; Drug: Escitalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT03527043

1608017504

Details and patient eligibility

About

Double-blind placebo-controlled randomized trial of daily escitalopram for 6 weeks in healthy men with normal semen analyses and no psychiatric history of depression, bipolar, mania or suicidal ideation. Hormone profiles, semen analysis, sperm DNA fragmentation, and sexual function will be measured at baseline, after 6 weeks of therapy, and 4 weeks after discontinuation of therapy (10 weeks into study).

Full description

SSRI medications, specifically escitalopram is a very commonly prescribed medication among men of reproductive age. Significant evidence exists that they may be harmful for paternal fertility potential in both animal and human studies. However, high quality data is lacking, particularly among commonly used SSRI's such as escitalopram. As such, it is important to properly evaluate the potential effect of escitalopram in a randomized placebo controlled fashion. Results will be important in guiding urologists, psychiatrists and family practitioners regarding discussion surrounding SSRI use in their patients interested in fertility.

Enrollment: 70 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal semen analyses, or semen analyses with at least 5 million sperm
• Normal TUNEL value (<7%)
• Willing to engage in at least weekly sexual activity, with a partner or alone for the duration of the 10-week study

Exclusion criteria

• Azoospermia or severe oligospermia (<5million sperm per semen analysis)
• Presently attempting to conceive pregnancy
• Sexual dysfunction preventing ability to provide semen analysis throughout study or engage in weekly sexual activity
• Current psychiatric disorder including: bipolar, mania, depression, generalized anxiety, social phobia, panic attacks, obsessive compulsive disorder, and schizophrenia.
• Family history of bipolar disorder, or suicide (including 2nd degree relatives)
• Present use of psychotropic agents (prescription or herbal) or anticonvulsants
• Use of sleeping pills
• Alcohol consumption greater that 2oz/day
• Use of illicit drugs
• Inability to read, follow instructions or complete questionnaires in English.
• Use of hormonal medications in past 3 months (androgens, androgen blockade, anabolic steroids, estrogens, herbal)
• Use of medications to enhance sexual function
• History of chemotherapy or pelvic radiation
• Use of Monoamine Oxidase inhibitors (MAOi's) or tricyclic antidepressants (TCAs) within 14 days
• Liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Escitalopram

Experimental group

Description:

10mg by mouth daily for 6 weeks

Treatment:

Drug: Escitalopram

Placebo

Placebo Comparator group

Description:

Matched placebo control by mouth for 6 weeks.

Treatment:

Other: Placebo