Study With Vortioxetine on Emotional Functioning in Patients With Depression
NCT ID: NCT03835715
Last Updated: 2020-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2019-02-05
2020-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vortioxetine
Vortioxetine
Flexible doses (10-20 mg) of vortioxetine; 10 mg during the first week which may be increased up to 20 mg week 2-8
Interventions
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Vortioxetine
Flexible doses (10-20 mg) of vortioxetine; 10 mg during the first week which may be increased up to 20 mg week 2-8
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Office of Dr. Patrick Bourgoin (FR0011)
Angoulême, , France
Cabinet Psyche (FR0012)
Douai, , France
Centre Medical Ambroise Pare (FR0007)
Élancourt, , France
Dr. David Modavi Md, Office Of (FR0001)
Toulouse, , France
Private Practice Dr. Paule Khalifa (FR0010)
Toulouse, , France
GHS De Nancy - CPN Laxou (FR0006)
Vandœuvre-lès-Nancy, , France
Dr Karim Boutayeb MD, Office of (FR0009)
Viersat, , France
DSM Giulianova c/o ospedale di Giulianova (IT0004)
Giulianova, , Italy
Dipartimento Salute Mentale ASL Lecce (IT0006)
Lecce, , Italy
Universita degli Studi di Roma La Sapienza - Azienda Ospedaliera Sant Andrea (IT0013)
Rome, , Italy
JSC Romuvos Klinika (LT0002)
Kaunas, , Lithuania
Mental Health Centre Kaunas Outpatient Clinic (LT0005)
Kaunas, , Lithuania
JSC Nefridos klinika (LT0006)
Klaipėda, , Lithuania
Jsc Silutes Mental Health And Psychotherapy Center (LT0001)
Šilutė, , Lithuania
Antakalnis Psychiatric Consultation Centre (LT0003)
Vilnius, , Lithuania
PI Mental Health Center of Zirmunai (LT0004)
Vilnius, , Lithuania
Hospital Universitario Fundacion Alcorcon (ES0009)
Alcorcón, , Spain
Instituto Internacional de Neurociencias Aplicadas (ES0004)
Barcelona, , Spain
Centro De Salud Mental De Foios (ES0002)
Foios, , Spain
University of Oviedo (ES0011)
Oviedo, , Spain
Francesca Canellas Dols (ES0005)
Palma de Mallorca, , Spain
Hospital Clínico Universiatrio de Salamanca (ES0001)
Salamanca, , Spain
Centro De Especialidades A Doblada (ES0006)
Vigo, , Spain
Countries
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References
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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.
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.
Other Identifiers
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17797A
Identifier Type: -
Identifier Source: org_study_id
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