Clinical trial NCT03835715: Study With Vortioxetine on Emotional Functioning in Patients With Depression
Official title: Interventional, Open-label, Flexible-dose Study of Vortioxetine on Emotional Functioning in Patients With Major Depressive Disorder With Inadequate Response to SSRI/SNRI Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2019-02-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Change from baseline to Week 8 in Oxford Depression Questionnaire (ODQ) total score
timeFrame: From baseline to Week 8
Secondary outcomes:
measure: Change from baseline to Week 8 in MEI total score.
timeFrame: From baseline to Week 8
measure: Change from baseline to Week 8 in DSST total score
timeFrame: From baseline to Week 8
measure: Change from baseline to Week 8 in ODQ domain scores (NC, ED, PR, GR, and AC)
timeFrame: From baseline to Week 8
measure: Change from baseline to Week 8 in MADRS total score
timeFrame: From baseline to Week 8
measure: Change from baseline to Week 8 in SDS individual item scores (family, work, and social life)
timeFrame: From baseline to Week 8
measure: Change from baseline to Week 8 in SDS total scores
timeFrame: From baseline to Week 8
measure: Change from baseline to Week 8 in CGI-S score
timeFrame: From baseline to Week 8
measure: CGI-I score at Week 8
timeFrame: at Week 8
Other outcomes:
Locations:
city: Angoulême
country: France
facility: Office of Dr. Patrick Bourgoin (FR0011)
city: Douai
country: France
facility: Cabinet Psyche (FR0012)
city: Toulouse
country: France
facility: Dr. David Modavi Md, Office Of (FR0001)
city: Toulouse
country: France
facility: Private Practice Dr. Paule Khalifa (FR0010)
city: Vandœuvre-lès-Nancy
country: France
facility: GHS De Nancy - CPN Laxou (FR0006)
city: Viersat
country: France
facility: Dr Karim Boutayeb MD, Office of (FR0009)
city: Élancourt
country: France
facility: Centre Medical Ambroise Pare (FR0007)
city: Giulianova
country: Italy
facility: DSM Giulianova c/o ospedale di Giulianova (IT0004)
city: Lecce
country: Italy
facility: Dipartimento Salute Mentale ASL Lecce (IT0006)
city: Rome
country: Italy
facility: Universita degli Studi di Roma La Sapienza - Azienda Ospedaliera Sant Andrea (IT0013)
city: Kaunas
country: Lithuania
facility: JSC Romuvos Klinika (LT0002)
city: Kaunas
country: Lithuania
facility: Mental Health Centre Kaunas Outpatient Clinic (LT0005)
city: Klaipėda
country: Lithuania
facility: JSC Nefridos klinika (LT0006)
city: Silute
country: Lithuania
facility: Jsc Silutes Mental Health And Psychotherapy Center (LT0001)
city: Vilnius
country: Lithuania
facility: Antakalnis Psychiatric Consultation Centre (LT0003)
city: Vilnius
country: Lithuania
facility: PI Mental Health Center of Zirmunai (LT0004)
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundacion Alcorcon (ES0009)
city: Barcelona
country: Spain
facility: Instituto Internacional de Neurociencias Aplicadas (ES0004)
city: Foios
country: Spain
facility: Centro De Salud Mental De Foios (ES0002)
city: Oviedo
country: Spain
facility: University of Oviedo (ES0011)
city: Palma De Mallorca
country: Spain
facility: Francesca Canellas Dols (ES0005)
city: Salamanca
country: Spain
facility: Hospital Clínico Universiatrio de Salamanca (ES0001)
city: Vigo
country: Spain
facility: Centro De Especialidades A Doblada (ES0006)
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.