Vortioxetine (Lu AA21004) 10 and 20 mg for Treatment of Major Depressive Disorder With Sexual Dysfunction
Condition: Treatment Outcome
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine; Escitalopram; Placebo
Intervention description: Vortioxetine tablets; Escitalopram tablets; Vortioxetine Placebo-matching capsules
Intervention MeSH terms: Vortioxetine; Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 447.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Sexual Dysfunction, Physiological; Depressive Disorder, Major; Depression; Antidepressive Agents; Drug Therapy

Summary:

      The purpose of this study is to evaluate the effects of Vortioxetine (Lu AA21004), once daily
      (QD), compared with escitalopram on sexual functioning.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a man or a woman aged between 18 and 55 years, inclusive, who is currently being
             treated with selective serotonin reuptake inhibitor (SSRI) monotherapy (only
             citalopram, paroxetine, or sertraline allowed) for at least 8 weeks, which was
             prescribed to treat a major depressive episode (MDE), according to the DSM-IV-TR
             criteria.

          2. Is currently stable; and has a Clinical Global Impression Scale-Severity of Illness
             Scale (CGI-S) score of ≤3.

          3. Is currently experiencing treatment-emergent sexual dysfunction (TESD; defined as a
             Changes in Sexual Functioning Questionnaire (CSFQ-14) total score ≤41 for women and
             ≤47 for men), considered to be attributable to the current SSRI monotherapy and is
             suitable for a switch.

        Exclusion Criteria:

          1. Has previously participated in a Lu AA21004 clinical study.

          2. Has 1 or more the following: any current psychiatric disorder other than MDD as
             defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition,
             Text Revision (DSM-IV-TR; as assessed by the Mini International Neuropsychiatric
             Interview Version 6.0.0); current or history of manic or hypomanic episode,
             schizophrenia, or any other psychotic disorder, including major depression with
             psychotic features, mental retardation, organic mental disorders, or mental disorders
             due to a general medical condition as defined in the DSM-IV-TR; current diagnosis of
             alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as
             defined in the DSM-IV-TR that has not been in sustained full remission for at least 2
             years prior to Screening (subject must also have negative urine drug screen prior to
             Baseline); presence or history of a clinically significant neurological disorder
             (including epilepsy); neurodegenerative disorder (Alzheimer disease, Parkinson
             disease, multiple sclerosis, Huntington disease, etc); or any Axis II disorder that
             might compromise the study.

          3. Has sexual dysfunction associated with an etiology other than SSRI treatment or
             current MDE (e.g., due to a medical condition, such as diabetes or hypertension, a
             medication, a genital anatomical deformity, or alcohol abuse).

          4. Is nonsexually active or anticipates decreasing frequency of sexual activity (ie,
             sexual activity anticipated to lead to orgasm or that would normally lead to orgasm,
             which can include sexual intercourse, oral sex, masturbation, sexual fantasies, and/or
             thinking of sexual activity) during the course of the study below the level at study
             initiation.

          5. Is a male with a history of premature ejaculation in the past year.

          6. Has had major relationship changes during the preceding SSRI treatment period or plans
             to have major relationship changes during the course of the study.

          7. Has a sexual partner(s) who plans to initiate treatment for sexual dysfunction during
             the study.