A study to evaluate the effect and safety of a product named vortioxetine (used in depression) when combining vortioxetine tablets with an injection of vortioxetine. Investigator and subjects will be blinded.

Phase 1

Conditions: Major Depressive Disorder
MedDRA version: 19.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2015-005081-30-LT

Lead Sponsor: H. Lundbeck A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 54

Inclusion Criteria

• The patient has recurrent Major Depressive Disorder (MDD), diagnosed according to Diagnostic and Statistical Manual for Mental Disorders, 5th Edition (DSM-5™), classification code (296.3x). The recurrent Major Depressive Episode (MDE) should be confirmed using the Mini-International Neuropsychiatric Interview (MINI).

• The patient has a Montgomery Åsberg Depression Rating Scale (MADRS) total score =30 at both Screening and Baseline Visits.

• The patient has had the current MDE for =3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• The patient has any current psychiatric disorder or Axis I disorder (DSM-5™criteria), other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI).

• The patient has a current diagnosis of history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (DSM-5™ criteria).

• The patient suffers from personality disorders, intellectual disability, pervasive development disorder, attention deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-5™criteria).

• The patient has a history of lack of response to previous treatment with vortioxetine (including current episode).

Other Protocol defined inclusion and exclusion criteria may apply