Clinical trial NCT03766867: Vortioxetine Intravenous Infusion at Initiation of Oral Treatment With Vortioxetine in Patients With Depression
Official title: Interventional, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Initial Administration of 25 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2018-12-06
Enrollment: 80
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: 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

Detailed description: The study consists of a 7-day double-blind Treatment Period (Day 0 to Day 6)

Eligibility 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.

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 in- and exclusion criteria may apply

Primary outcomes:
measure: Change from baseline (Day 0) to Day 1 (24 h post-infusion) in MADRS-6 subscale score
timeFrame: From baseline (Day 0) to Day 1 (24 h post-infusion)
Secondary outcomes:
measure: Change from baseline (Day 0) to Day 3 in MADRS-6 subscale score
timeFrame: From baseline (Day 0) to Day 3
measure: Change from baseline (Day 0) to Day 7 in MADRS-6 subscale score
timeFrame: From baseline (Day 0) to Day 7
measure: Change in MADRS total score from baseline to Day 1, Day 3, Day 7
timeFrame: From baseline to Day 1, Day 3, Day 7
measure: ≥50% decrease in MADRS total score from baseline on Day 1 and Day 3
timeFrame: On Day 1 and Day 3
measure: CGI-I score at Day 1, Day 3, Day 7
timeFrame: At Day 1, Day 3, Day 7
measure: CGI-I response (defined as CGI-I score ≤2) on Day 1 and 3
timeFrame: At Day 1 and 3
measure: Change from baseline in CGI-S score to Day 1, Day 3, Day 7
timeFrame: From baseline to Day 1, Day 3, Day 7
measure: CL/F of vortioxetine
timeFrame: Day 0, Day 1, Day 7
measure: Cav
timeFrame: Day 0, Day 1, Day 7
Other outcomes:
Locations:
city: Burgas
country: Bulgaria
facility: Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD (BG1004)
city: Kardzhali
country: Bulgaria
facility: SPH - Kardzhali, EOOD (BG1005)
city: Kazanlak
country: Bulgaria
facility: MHAT "Dr. Hristo Stambolski", EOOD (BG1001)
city: Novi Iskar
country: Bulgaria
facility: State Psychiatric Hospital "Sv. Ivan Rilski" (BG1009)
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD (BG1006)
city: Ruse
country: Bulgaria
facility: MHC - Ruse, EOOD (BG1007)
city: Tsarev Brod
country: Bulgaria
facility: State Psychiatric Hospital (BG1008)
city: Vratsa
country: Bulgaria
facility: Mental Health Center-Vratsa EOOD (BG1002)
city: Tallinn
country: Estonia
facility: Marienthali Kliinik (EE2001)
city: Tartu
country: Estonia
facility: Tartu University Hospital (EE2002)
city: Daugavpils
country: Latvia
facility: Psychoneurological Hospital of Daugavpils (LV3003)
city: Riga
country: Latvia
facility: Riga Centre of Psychiatry and Narcology (LV3002)
city: Strenči
country: Latvia
facility: Psychoneurological Hospital of Strenci (LV3001)
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Rancans E, Zambori J, Dalsgaard M, Baayen C, Areberg J, Ettrup A, Florea I. Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 7-day randomized, double-blind, placebo-controlled exploratory study. Int Clin Psychopharmacol. 2020 Nov;35(6):305-312. doi: 10.1097/YIC.0000000000000326.