Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

H. Lundbeck A/S

Conditions:

Major Depressive Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

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

  • 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

Exclusion

    Key Trial Info

    Start Date :

    December 3 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 28 2019

    Estimated Enrollment :

    80 Patients enrolled

    Trial Details

    Trial ID

    NCT03766867

    Start Date

    December 3 2018

    End Date

    August 28 2019

    Last Update

    August 29 2019

    Active Locations (13)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (13 locations)

    1

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

    Burgas, Bulgaria

    2

    SPH - Kardzhali, EOOD (BG1005)

    Kardzhali, Bulgaria

    3

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

    Kazanlak, Bulgaria

    4

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

    Novi Iskar, Bulgaria