Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive Disorder

The drug being tested in this study is called Vortioxetine. Vortioxetine is being tested to
treat depression in people who have major depressive disorder. This study will look at
effectiveness of treatment with vortioxetine in participant's goal achievement for the
treatment of major depressive disorder.

The study will enroll approximately 120 patients. Participants will receive:

• Vortioxetine 10 to 20 mg

All participants will be asked to take one tablet at the same time each day throughout the
study. The participants will receive a starting dose of 10 mg. The dose may be up-titrated to
20 mg. The dose may then be decreased by 5 mg based on participant's response and
tolerability to higher dose as judged by the Investigator.

This multi-center trial will be conducted in Unites States. The overall time to participate
in this study is 19 weeks. Participants will make multiple visits to the clinic, and will be
contacted by telephone for 4 weeks after last dose of study drug for a follow-up assessment.

Inclusion Criteria:

1. Is suffering from Major Depressive Disorder (MDD) as the primary psychiatric
diagnosis.

2. Has been or is currently being treated with an approved antidepressant (monotherapy)
for 6 weeks or longer at an adequate therapeutic dose. Participants currently on an
antidepressant at Screening will be discontinued in a manner that is consistent with
labeling recommendations and conventional medical practice.

3. The antidepressant treatment must be on-going at time of Screening, or have been
discontinued within the 6 weeks prior to Screening.

4. Is considered appropriate for a change in antidepressant medication based on
Investigator judgment in collaboration with the participant.

5. Has scores on Patient Health Questionnaire (PHQ-9) ≥5 and Clinical Global Impression
Scale Severity (CGI-S ≥4).

Exclusion Criteria:

1. Has discontinued prior antidepressant treatment greater than 6 weeks from Screening.

2. Is considered to be at imminent risk for hospitalization due to severe depression in
the opinion of the investigator. Recent hospitalization due to MDD within 3 months
prior to Screening is exclusionary also.

3. Has a significant risk of suicide according to the Investigator's clinical judgment or
has made an actual suicide attempt in the previous 6 months prior to Screening or
scores "yes" on items 4 or 5 in the past 6 months on the Suicidal Ideation section of
the Columbia Suicide Severity Rating Scale (C-SSRS).

4. Is considered to be treatment resistant, defined as participants with MDD who have not
responded to 2 or more separate different antidepressant monotherapy trials of
adequate dose and duration (6 weeks or longer) in their current episode. History of
only responding to combination or augmentation therapy in previous major depressive
episode (MDEs) is also considered evidence of treatment resistant depression.

5. Has 1 or more of the following:

1. Current or history of: manic or hypomanic episode, schizophrenia or any other
psychotic disorder, including schizoaffective disorder, major depression with
psychotic features, bipolar depression with psychotic features, obsessive
compulsive disorder, mental retardation, organic mental disorders, or mental
disorders due to a general medical condition as defined in Diagnostic and
Statistical Manual of Mental Disorders (DSM-5) as determined by the investigator.

2. Current diagnosis or history of alcohol or other substance abuse or dependence
(excluding nicotine or caffeine). The participants must have a negative urine
drug screen (UDS) at Screening and Baseline, this includes benzodiazepines and
opiates (including oxycodone) for which there is no prescription.

3. Presence or history of a clinically significant neurological disorder (including
epilepsy) as determined by the investigator.

4. Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple
sclerosis, Huntington disease, etc).

6. Has a known history of acute narrow-angle glaucoma or is at risk of acute narrow-angle
glaucoma.

7. Has a known unstable thyroid disorder or a thyroid-stimulating hormone value outside
the normal range based on medical history that is deemed clinically significant by the
investigator.

8. Has active hepatitis B or a known history of hepatitis C virus.

9. Has a known history of human immunodeficiency virus infection.

10. Has a history of gastric bypass.

11. Has previously or is currently participating in this study or another vortioxetine or
LuAA21004 study.

12. Is receiving or who have started receiving formal cognitive or behavioral therapy,
systematic psychotherapy within 30 days from screening or plan to initiate such
therapy during the study.