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 range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-04

Results submitted2025-01-17

View on ClinicalTrials.gov More Sperm DNA Fragmentation trials