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.

Interventional, randomised, double-blind, parallel-group study of the efficacy and safety of initial administration of 17 mg vortioxetine intravenously with 10 mg/day vortioxetine orally in patients with Major Depressive Disorder

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005081-30-EE

Enrollment

Registered

2016-06-08

Start date

2016-08-01

Completion date

Unknown

Last updated

2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder MedDRA version: 19.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: vortioxetine – 1 mg/mL, concentrate for solution for infusion Product Code: vortioxetine Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: VORTIOXETINE CAS

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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: - global clinical impression - anxiety symptoms To determine population pharmacokinetic parameters of vortioxetine ;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	—

Measure

Time frame

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: - global clinical impression - anxiety symptoms To determine population pharmacokinetic parameters of vortioxetine ;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

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Secondary

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

Measure

Time frame

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

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Countries

Estonia, Finland, Lithuania, Slovakia

Contacts

Public ContactLundbeck Clinical Trials

H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com+45 36 3013 11

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026