NCT03835715

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4 major-depressive-disorder

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_4 major-depressive-disorder

Geographic Reach
4 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2020

Completed
Last Updated

March 24, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

February 7, 2019

Last Update Submit

March 23, 2020

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to Week 8 in Oxford Depression Questionnaire (ODQ) total score

    The ODQ is a patient-centred, self-report measure of emotional symptoms present in patients treated with antidepressants. The ODQ is a 26-item patient self-complete measure, spread over 3 sections and covering 5 dimensions of: not caring (NC), emotional detachment (ED), positive reduction (PR), general reduction (GR), and antidepressant as cause (AC). Response options are based on 5-point Likert scale with a score applied to each response.

    From baseline to Week 8

Secondary Outcomes (8)

  • Change from baseline to Week 8 in MEI total score.

    From baseline to Week 8

  • Change from baseline to Week 8 in DSST total score

    From baseline to Week 8

  • Change from baseline to Week 8 in ODQ domain scores (NC, ED, PR, GR, and AC)

    From baseline to Week 8

  • Change from baseline to Week 8 in MADRS total score

    From baseline to Week 8

  • Change from baseline to Week 8 in SDS individual item scores (family, work, and social life)

    From baseline to Week 8

  • +3 more secondary outcomes

Study Arms (1)

Vortioxetine

EXPERIMENTAL
Drug: Vortioxetine

Interventions

VortioxetineDRUG

Flexible doses (10-20 mg) of vortioxetine; 10 mg during the first week which may be increased up to 20 mg week 2-8

Also known as: Brintellix ®
Vortioxetine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Office of Dr. Patrick Bourgoin (FR0011)

Angoulême, France

Location

Cabinet Psyche (FR0012)

Douai, France

Location

Centre Medical Ambroise Pare (FR0007)

Élancourt, France

Location

Dr. David Modavi Md, Office Of (FR0001)

Toulouse, France

Location

Private Practice Dr. Paule Khalifa (FR0010)

Toulouse, France

Location

GHS De Nancy - CPN Laxou (FR0006)

Vandœuvre-lès-Nancy, France

Location

Dr Karim Boutayeb MD, Office of (FR0009)

Viersat, France

Location

DSM Giulianova c/o ospedale di Giulianova (IT0004)

Giulianova, Italy

Location

Dipartimento Salute Mentale ASL Lecce (IT0006)

Lecce, Italy

Location

Universita degli Studi di Roma La Sapienza - Azienda Ospedaliera Sant Andrea (IT0013)

Rome, Italy

Location

JSC Romuvos Klinika (LT0002)

Kaunas, Lithuania

Location

Mental Health Centre Kaunas Outpatient Clinic (LT0005)

Kaunas, Lithuania

Location

JSC Nefridos klinika (LT0006)

Klaipėda, Lithuania

Location

Jsc Silutes Mental Health And Psychotherapy Center (LT0001)

Šilutė, Lithuania

Location

Antakalnis Psychiatric Consultation Centre (LT0003)

Vilnius, Lithuania

Location

PI Mental Health Center of Zirmunai (LT0004)

Vilnius, Lithuania

Location

Hospital Universitario Fundacion Alcorcon (ES0009)

Alcorcón, Spain

Location

Instituto Internacional de Neurociencias Aplicadas (ES0004)

Barcelona, Spain

Location

Centro De Salud Mental De Foios (ES0002)

Foios, Spain

Location

University of Oviedo (ES0011)

Oviedo, Spain

Location

Francesca Canellas Dols (ES0005)

Palma de Mallorca, Spain

Location

Hospital Clínico Universiatrio de Salamanca (ES0001)

Salamanca, Spain

Location

Centro De Especialidades A Doblada (ES0006)

Vigo, Spain

Location

Related Publications (2)

  • Christensen MC, Adair M, Loft H, McIntyre RS. The Motivation and Energy Inventory (MEI): Analysis of the clinically relevant response threshold in patients with major depressive disorder and emotional blunting using data from the COMPLETE study. J Affect Disord. 2023 Feb 15;323:547-553. doi: 10.1016/j.jad.2022.11.033. Epub 2022 Nov 14.

    PMID: 36395989DERIVED

  • Christensen MC, Fagiolini A, Florea I, Loft H, Cuomo A, Goodwin GM. Validation of the Oxford Depression Questionnaire: Sensitivity to change, minimal clinically important difference, and response threshold for the assessment of emotional blunting. J Affect Disord. 2021 Nov 1;294:924-931. doi: 10.1016/j.jad.2021.07.099. Epub 2021 Jul 31.

    PMID: 34378539DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 8, 2019

Study Start

February 5, 2019

Primary Completion

February 21, 2020

Study Completion

February 21, 2020

Last Updated

March 24, 2020

Record last verified: 2020-02

Locations

IT(3)ES(7)LI(6)FR(7)