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Status:

COMPLETED

Study With Vortioxetine on Emotional Functioning in Patients With Depression

Lead Sponsor:

H. Lundbeck A/S

Conditions:

Major Depressive Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief Summary

The study will evaluate effectiveness of flexible dose vortioxetine 10-20 mg/day on emotional functioning in patients with MDD with an inadequate response to SSRIs/SNRIs.

Eligibility Criteria

Inclusion

  • The patient has a primary diagnosis of single or recurrent MDD according to DSM-5®. The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
  • The patient has had the current MDE for \<12 months.
  • The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥ 22 and ≤ 28 at the Baseline Visit.
  • The patient has been treated with SSRI/SNRI monotherapy (citalopram, escitalopram, paroxetine, duloxetine or venlafaxine) for at least 6 weeks at adequate dose for the current MDE and with an inadequate response and is a candidate for a switch in the investigator's opinion.
  • The patient wants to switch antidepressant treatment.
  • The patient has an ODQ total score ≥50 at baseline, while on SSRI/SNRI monotherapy (prior to switch).
  • The patient answered "Yes "to the screening question on emotional effects.

Exclusion

  • \- The patient has a significant risk of suicide according to the investigator's clinical judgment or has made an actual suicide attempt in the previous 6 months prior to Baseline
  • Other in- and exclusion criteria may apply

Key Trial Info

Start Date :

February 5 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 21 2020

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT03835715

Start Date

February 5 2019

End Date

February 21 2020

Last Update

March 24 2020

Active Locations (23)

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

Page 1 of 6 (23 locations)

1

Office of Dr. Patrick Bourgoin (FR0011)

Angoulême, France

2

Cabinet Psyche (FR0012)

Douai, France

3

Centre Medical Ambroise Pare (FR0007)

Élancourt, France

4

Dr. David Modavi Md, Office Of (FR0001)

Toulouse, France