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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

NCT02919501 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2018-06-20

No results posted yet for this study

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

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Vortioxetine (IV)

17 mg, solution for infusion, administered, over 2 hours as single dose

OTHER

Placebo (IV)

Saline: isotonic sodium chloride, administered, over 2 hours as single dose

DRUG

Vortioxetine (tablet)

10 mg, tablets, oral administration once daily for 15 days (open labelled)

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • 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
2016-09-27
Primary Completion
2017-04-27
Completion
2017-04-27

Countries

  • Estonia
  • Finland

Study Locations

More Related Trials

Entities

Companies

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 NCT02919501 on ClinicalTrials.gov