Major Depressive disorder MedDRA version: 20.0 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: vortioxetine – 1 mg/mL, concentrate
Product Code: vortioxetine
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: VORTIOXETINE
CAS Number: 508233-74-7
Curren
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The patient has recurrent MDD, diagnosed according to DSM-5® and confirmed using the Mini-International Neuropsychiatric Interview (MINI). • The patient has a MADRS total score = 30 at the Screening Visit. • As part of standard of care treatment, the patient is to be admitted to hospital due to the severity of the depressive symptoms and is willing to remain hospitalized for the duration of the study treatment period. • The patient has had the current MDE for =3 months but less than 12 months. • The patient has received treatment for the current episode with an SSRI/SNRI monotherapy (citalopram, escitalopram, paroxetine, duloxetine, venlafaxine, sertraline) at an approved dose for at least 6 weeks. Other inclusion criteria may apply 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 80 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), established as the primary diagnosis, other than MDD, as assessed using the MINI or another diagnostic interview Other exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the efficacy and safety of vortioxetine given as a single intravenous dose of 25 mg at initiation of an oral vortioxetine regimen of 10 mg/day for 7 days;Secondary Objective: • to evaluate the efficacy of vortioxetine 25 mg intravenously (single initial dose) administered with a vortioxetine 10 mg/day oral dose regimen on global clinical impression • to determine population pharmacokinetic parameters of vortioxetine ;Primary end point(s): 1. Change from baseline (Day 0) to Day 1 (24 h post-infusion) in MADRS-6 subscale score ;Timepoint(s) of evaluation of this end point: From baseline (Day 0) to Day 1 (24 h post-infusion) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline (Day 0) to Day 3 in MADRS-6 subscale score 2. Change from baseline (Day 0) to Day 7 in MADRS-6 subscale score 3. Change in MADRS total score from baseline to Day 1, Day 3, Day 7 4. =50% decrease in MADRS total score from baseline on Day 1 and Day 3 5. CGI-I score at Day 1, Day 3, Day 7 6. CGI-I response (defined as CGI-I score =2) on Day 1 and 3 7. Change from baseline in CGI-S score to Day 1, Day 3, Day 7 8. Total clearance of the drug from plasma after oral administration (CL/F) of vortioxetine 9. Average plasma concentration during a steady-state day (Cav). ;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Countries
Bulgaria, Estonia, Latvia, Ukraine
Contacts
Public ContactLundbeck Clinical Trials
H. Lundbeck A/S
Outcome results
None listed