Impact of Escitalopram on Sperm DNA Fragmentation (NCT03527043) | Clinical Trial Compass
TerminatedPhase 2
Impact of Escitalopram on Sperm DNA Fragmentation
Stopped: funding stopped
United States75 participantsStarted 2017-10-01
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexMALE
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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
What they're measuring
1
Percentage of Patients Who Have Abnormal (>7%) TUNEL DNA Fragmentation Levels After 6 Weeks of Treatment
Timeframe: 6 weeks
Trial details
NCT IDNCT03527043
SponsorWeill Medical College of Cornell University