Clinical trial NCT02919501: 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder, Major
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Takeda
First posted: 2016-09-29
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (IV) and vortioxetine 10 mg/day oral dose regimen versus placebo IV and vortioxetine 10 mg/day oral dose regimen on depressive symptoms


Eligibility 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

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

Primary outcomes:
measure: Change from baseline to Week 1 in MADRS total score
timeFrame: Baseline to Week 1
Secondary outcomes:
measure: Change from baseline to Week 2 in MADRS total score
timeFrame: Baseline to Week 2
measure: Change from baseline to Day 3 in MADRS total score
timeFrame: Baseline to Day 3
measure: Change from baseline to Day 1 in MADRS total score
timeFrame: Baseline to Day 1
measure: Response (defined as a ≥ 50% decrease in MADRS total score from baseline) at Week 1
timeFrame: Week 1
measure: Remission at Week 1 (defined as a MADRS total score ≤ 10)
timeFrame: Week 1
measure: Change from baseline to Week 1 in HADS depression subscale
timeFrame: baseline to Week 1
measure: Global clinical impression -Global Improvement
timeFrame: At Week 1
measure: Change from baseline in Global clinical impression -Severity
timeFrame: Baseline to Week 1
measure: Oral clearance (CL/F)
timeFrame: 2, 8 and 24 hours postdose (day 1) and day 14
measure: Average Plasma Concentration (Cav)
timeFrame: 2, 8 and 24 hours postdose (day 1) and day 14
measure: Change from baseline to Week 1 in HADS anxiety subscale
timeFrame: Baseline to Week 1
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: EE1019
city: Tallinn
country: Estonia
facility: EE1020
city: Helsinki
country: Finland
facility: FI1040
city: Helsinki
country: Finland
facility: FI1041
city: Kuopio
country: Finland
facility: FI1030
city: Pori
country: Finland
facility: FI1009
city: Turku
country: Finland
facility: FI1027
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Vieta E, Florea I, Schmidt SN, Areberg J, Ettrup A. Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 2-week, randomized, double-blind, placebo-controlled study. Int Clin Psychopharmacol. 2019 Jul;34(4):153-160. doi: 10.1097/YIC.0000000000000271.