Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers

Exclusion Criteria

• •1. Has received vortioxetine and/or paroxetine in a previous clinical study or as a therapeutic agent.
• •2. Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) at the Screening Visit or has any known sexually transmitted diseases.
• •3. Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit.
• •4. Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit.
• •5. Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
• •6. Has a history of depression or any other psychiatric illness.
• •7. Has a significant risk of suicide according to the investigator's clinical judgment, or has made a suicide attempt in the previous 6 months.
• •8. Has current sexual dysfunction, or a history of a diagnosis or treatment of sexual dysfunction.
• •9. Has had a surgical or medical procedure on reproductive/genitourinary organs (excluding uncomplicated vasectomy and tubal ligation).
• •10. If female, has polycystic ovarian syndrome.
• •11. Has hypogonadism or has a free testosterone value outside the normal range at the Screening Visit that is indicative of hypogonadism.
• •12. Has a thyroid-stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.