Investigating the Effect of Vortioxetine in Adult ADHD Patients

The study employed the Sequential Parallel Comparison Design (SPCD), a clinical study design
which intend to increase signal detection by using two stages of treatment:

- Stage 1 - first 6 weeks of the 12-weeks treatment period (Visit 2/Baseline 1 to Visit
5/Week 6)

- Stage 2 - last 6 weeks of the 12-weeks treatment period (Visit 5/Baseline 2 to Visit
8/Week 12)

In Stage 1, patients were randomized to placebo or vortioxetine 10 or 20mg. Patients on
vortioxetine 10 or 20mg/day during Stage 1 remained on the same treatment in Stage 2.
Responders to placebo in Stage 1 remained on Placebo in Stage 2. Patients who were placebo
non-responders during Stage 1, defined as patients with a <30% reduction in AISRS total score
from Baseline 1, were re-randomized to placebo or vortioxetine 10 or 20mg/day in Stage 2.

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