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: 19.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2015-005081-30-SK

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the early onset of efficacy of vortioxetine 17 mg IV and vortioxetine 10 mg/day oral dose regimen versus vortioxetine 10 mg/day oral dose regimen on depressive symptoms;Secondary Objective: To evaluate the early onset of efficacy of vortioxetine 17 mg IV and vortioxetine 10 mg/day oral dose regimen versus vortioxetine 10 mg/day oral dose regimen on:<br>- global clinical impression<br>- anxiety symptoms<br><br>To determine population pharmacokinetic parameters of vortioxetine<br>;Primary end point(s): Change from baseline to Week 1 in MADRS total score;Timepoint(s) of evaluation of this end point: Throughout the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Response (defined as a = 50% decrease in MADRS total score from baseline) at Week 1<br><br>• Remission at Week 1 (defined as a MADRS total score = 10)<br><br>• Change from baseline to Week 1 in HADS depression subscale<br><br>• Global clinical impression - Global Improvement<br><br>• Change from baseline in Global clinical impression – Severity<br><br>• Oral clearance (CL/F)<br><br>• Average Plasma Concentration (Cav)<br><br>• Change from baseline to Week 1 in HADS anxiety subscale<br>;Timepoint(s) of evaluation of this end point: Throughout the study