Investigating the Effect of Vortioxetine in Adult ADHD Patients
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: vortioxetine 10 mg tablet; vortioxetine 20 mg tablet; Placebo tablet
Intervention description: Oral tablets, once daily; Oral tablets, once daily; Oral tablets, once daily
Intervention MeSH terms: Vortioxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 227.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose is to determine the effect of vortioxetine treatment on ADHD symptoms in adult
      patients with ADHD in a 12 weeks study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is willing and able to attend study appointments within the specified time
             windows.

          -  The patient is an outpatient.

          -  The patient is diagnosed with a primary diagnosis of ADHD according to the DSM-5™
             classification.

          -  The patient has an AISRS total score ≥24.

          -  The patient has a CGI-S rating ≥4 (moderately ill or worse).

        Exclusion Criteria:

          -  The patient has previously been treated with vortioxetine.

          -  The patient has any current psychiatric disorder (DSM-IV-TR™ criteria), other than
             ADHD, as assessed using the Mini International Neuropsychiatric Interview (MINI).

          -  The patient has a known first-degree relative with bipolar disorder.

          -  The patient suffers from intellectual disability as evaluated by the Wechsler
             Abbreviated Scale of Intelligence (WASI) II vocabulary and matrix.

          -  The patient suffers from organic mental disorders, or mental disorders due to a
             general medical condition (DSM-5™ criteria).

          -  The patient has reported current use of, or has tested positive for, drugs of abuse
             (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates,
             benzodiazepines, and cannabinoids). If a patient tests positive for opiates due to
             incidental use of codeine containing medication, as assessed in a clinical interview,
             the drug screen may be repeated up to three weeks later but the retest result must be
             available from the central laboratory latest at Visit 2 and has to be negative for
             this patient to be eligible for enrolment. If a patient tests positive for
             amphetamines due to his/her ADHD current treatment, as confirmed by a clinical
             interview, the patient is eligible for enrolment provided this treatment is
             discontinued two weeks prior to the Baseline Visit.

          -  The patient has a history of two prior failed (<50% improvement in symptoms) adequate
             trials of ADHD treatment.

          -  The patient has any other disorder for which the treatment takes priority over
             treatment of ADHD or is likely to interfere with study treatment or impair treatment
             compliance.

          -  The patient has a history of moderate or severe head trauma or other neurological
             disorders or systemic medical diseases that are, in the investigator's opinion, likely
             to affect central nervous system functioning.

          -  The patient has attempted suicide within the last 6 months or is at significant risk
             of suicide (either in the opinion of the Investigator or defined as a "yes" to
             suicidal ideation questions 4 or 5 or answering "yes" to suicidal behaviour on the
             Columbia-Suicide Rating Scale (C-SSRS) within the last 12 months).

        Other protocol defined inclusion and exclusion criteria do apply