Vortioxetine Intravenous Infusion at Initiation of Oral Treatment With Vortioxetine in Patients With Depression

NCT03766867 | Completed Phase 2

• 1 other identifier: 17915A
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 13

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change from baseline (Day 0) to Day 1 (24 h post-infusion) in MADRS-6 subscale score

  The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The primary endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.

  From baseline (Day 0) to Day 1 (24 h post-infusion)

Secondary Outcomes (9)

• Change from baseline (Day 0) to Day 3 in MADRS-6 subscale score

  From baseline (Day 0) to Day 3

• Change from baseline (Day 0) to Day 7 in MADRS-6 subscale score

  From baseline (Day 0) to Day 7

• Change in MADRS total score from baseline to Day 1, Day 3, Day 7

  From baseline to Day 1, Day 3, Day 7

• ≥50% decrease in MADRS total score from baseline on Day 1 and Day 3

  On Day 1 and Day 3

• CGI-I score at Day 1, Day 3, Day 7

  At Day 1, Day 3, Day 7

Study Arms (2)

Vortioxetine

EXPERIMENTAL

Drug: Vortioxetine infusion 25 mg; Drug: Vortioxetine tablets 10 mg/day

Placebo

PLACEBO COMPARATOR

Drug: Placebo infusion; Drug: Placebo tablets

Interventions

Vortioxetine infusion 25 mg DRUG

1 mg/mL, concentrate for solution for infusion, 25 mL (25 mg) administered in 250 mL saline over 2 hours as single dose for 7 days

Vortioxetine

Vortioxetine tablets 10 mg/day DRUG

10 mg, tablets, oral administration once daily

Also known as: Brintellix ®

Vortioxetine

Placebo infusion DRUG

concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose

Placebo

Placebo tablets DRUG

oral administration once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (13)

Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD (BG1004)

Burgas, Bulgaria

Location

SPH - Kardzhali, EOOD (BG1005)

Kardzhali, Bulgaria

Location

MHAT "Dr. Hristo Stambolski", EOOD (BG1001)

Kazanlak, Bulgaria

Location

State Psychiatric Hospital "Sv. Ivan Rilski" (BG1009)

Novi Iskar, Bulgaria

Location

UMHAT 'Dr. Georgi Stranski', EAD (BG1006)

Pleven, Bulgaria

Location

MHC - Ruse, EOOD (BG1007)

Rousse, Bulgaria

Location

State Psychiatric Hospital (BG1008)

Tsarev Brod, Bulgaria

Location

Mental Health Center-Vratsa EOOD (BG1002)

Vratsa, Bulgaria

Location

Marienthali Kliinik (EE2001)

Tallinn, Estonia

Location

Tartu University Hospital (EE2002)

Tartu, Estonia

Location

Psychoneurological Hospital of Daugavpils (LV3003)

Daugavpils, Latvia

Location

Riga Centre of Psychiatry and Narcology (LV3002)

Riga, Latvia

Location

Psychoneurological Hospital of Strenci (LV3001)

Strenči, Latvia

Location

Related Publications (1)

• 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.

  PMID: 32784346 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 6, 2018
• Study Start: December 3, 2018
• Primary Completion: July 31, 2019
• Study Completion: August 28, 2019
• Last Updated: August 29, 2019

Record last verified: 2019-06

Locations

LA (3); BU (8); ES (2)