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.

• Register: EUCTR
• Last refreshed on: 29 May 2017
• Main ID: EUCTR2015-005081-30-FI
• Date of registration: 04/07/2016
• Prospective Registration: Yes
• Primary sponsor: H. Lundbeck A/S
• Public title: 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.
• Scientific title: 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
• Date of first enrolment: 02/08/2016
• Target sample size: 54
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005081-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Estonia, Finland, Lithuania, Slovakia

Contacts

• Name: Lundbeck Clinical Trials
• Affiliation: H. Lundbeck A/S

• Name: Lundbeck Clinical Trials
• Affiliation: H. Lundbeck A/S

Key inclusion & exclusion 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:
• 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Intervention(s)

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 Number: 508233-74-7
Current Sponsor code: Lu AA21004
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Brintellix 10 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VORTIOXETINE
CAS Number: 508233-74-7
Current Sponsor code: Lu AA21004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

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

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

Timepoint(s) of evaluation of this end point: Throughout the study

Secondary Outcome(s)

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

Secondary ID(s)

16903A

2015-005081-30-EE

Source(s) of Monetary Support

H. Lundbeck A/S