Impact of Escitalopram on Sperm DNA Fragmentation

Phase 2

Terminated

Brief Summary: 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).

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matched placebo control by mouth for 6 weeks.
Escitalopram	Escitalopram	10mg by mouth daily for 6 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Who Have Abnormal (>7%) TUNEL DNA Fragmentation Levels After 6 Weeks of Treatment	6 weeks	TUNEL assay for sperm DNA fragmentation,Percentage of patients who have abnormal (\>7%) TUNEL DNA fragmentation levels after 6 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Who Have Abnormal DNA Fragmentation Levels at 10 Weeks (4 Weeks Following Cessation of Treatment)	10 weeks	Tunnel assay of the DNA fragmentation, Percentage of patients who have abnormal DNA fragmentation levels at 10 weeks (4 weeks following cessation of treatment)
Absolute Change in DNA Fragmentation Percentage	0 (baseline), 6, 10 weeks	Absolute change in DNA fragmentation percentage across treatment groups from baseline