Study With Vortioxetine on Emotional Functioning in Patients With Depression

• Status: Completed
• Trial end date: 2020-02-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Vortioxetine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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