Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: Vortioxetine; Paroxetine; Placebo
Intervention description: Vortioxetine Overencapsulated Tablet; Paroxetine Overencapsulated Tablets.; Vortioxetine Placebo-matching Capsules.
Intervention MeSH terms: Vortioxetine; Paroxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 361.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the effect of vortioxetine (10 and 20 mg, once
      daily) versus paroxetine (20 mg, once daily) on sexual functioning in healthy participants
      after 5 weeks of double-blind treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is sexually active and has been in a steady relationship and plans to remain in that
             relationship for the duration of the study.

          2. Has a body mass index (BMI) of 18 to 35 kg/m^2, inclusive, at the Screening and
             Baseline Visits.

          3. If female, has a regular menstrual cycle.

          4. Has normal sexual functioning, as defined by a Changes in Sexual Functioning
             Questionnaire (CSFQ-14) total score >47 (men) or >41 (women) at the Screening and
             Baseline Visits.

          5. If females, taking allowed hormonal contraceptives is on a stable dose for ≥3 months
             prior to the Baseline Visit and continues on the stable dose for the duration of the
             study.

        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.