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

NCT03766867 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-08-29

No results posted yet for this study

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

Interventions

DRUG

Vortioxetine infusion 25 mg

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

DRUG

Vortioxetine tablets 10 mg/day

10 mg, tablets, oral administration once daily

DRUG

Placebo infusion

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

DRUG

Placebo tablets

oral administration once daily

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2019-07-31
Completion
2019-08-28

Countries

  • Bulgaria
  • Estonia
  • Latvia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03766867 on ClinicalTrials.gov