Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine
Intervention description: Vortioxetine tablet
Intervention MeSH terms: Vortioxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to determine the effectiveness of treatment with vortioxetine on
      participant goal achievement after a change in antidepressant medication for the treatment of
      major depressive disorder (MDD).
    

Eligibility criteria:

        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.