Study With Vortioxetine on Emotional Functioning in Patients With Depression (COMPLETE)

Interventional, Open-label, Flexible-dose Study of Vortioxetine on Emotional Functioning in Patients With Major Depressive Disorder With Inadequate Response to SSRI/SNRI Treatment

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Vortioxetine

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Angoulême, France
    • Office of Dr. Patrick Bourgoin (FR0011)
  • Douai, France
    • Cabinet Psyche (FR0012)
  • Toulouse, France
    • Dr. David Modavi Md, Office Of (FR0001)
  • Toulouse, France
    • Private Practice Dr. Paule Khalifa (FR0010)
  • Vandœuvre-lès-Nancy, France
    • GHS De Nancy - CPN Laxou (FR0006)
  • Viersat, France
    • Dr Karim Boutayeb MD, Office of (FR0009)
  • Élancourt, France
    • Centre Medical Ambroise Pare (FR0007)
• Italy
  • Giulianova, Italy
    • DSM Giulianova c/o ospedale di Giulianova (IT0004)
  • Lecce, Italy
    • Dipartimento Salute Mentale ASL Lecce (IT0006)
  • Rome, Italy
    • Universita degli Studi di Roma La Sapienza - Azienda Ospedaliera Sant Andrea (IT0013)
• Lithuania
  • Kaunas, Lithuania
    • JSC Romuvos Klinika (LT0002)
  • Kaunas, Lithuania
    • Mental Health Centre Kaunas Outpatient Clinic (LT0005)
  • Klaipėda, Lithuania
    • JSC Nefridos klinika (LT0006)
  • Silute, Lithuania
    • Jsc Silutes Mental Health And Psychotherapy Center (LT0001)
  • Vilnius, Lithuania
    • Antakalnis Psychiatric Consultation Centre (LT0003)
  • Vilnius, Lithuania
    • PI Mental Health Center of Zirmunai (LT0004)
• Spain
  • Alcorcón, Spain
    • Hospital Universitario Fundacion Alcorcon (ES0009)
  • Barcelona, Spain
    • Instituto Internacional de Neurociencias Aplicadas (ES0004)
  • Foios, Spain
    • Centro De Salud Mental De Foios (ES0002)
  • Oviedo, Spain
    • University of Oviedo (ES0011)
  • Palma De Mallorca, Spain
    • Francesca Canellas Dols (ES0005)
  • Salamanca, Spain
    • Hospital Clínico Universiatrio de Salamanca (ES0001)
  • Vigo, Spain
    • Centro De Especialidades A Doblada (ES0006)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vortioxetine	Drug: 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 Names: Brintellix ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to Week 8 in MEI total score.	The Motivation and Energy Inventory (MEI) is a 27-item scale initially developed and validated for the purpose of evaluating interventions to improve motivation and energy in patients with depression. The MEI assesses three domains: mental or cognitive energy, social motivation, and physical energy. Scoring Respondents use scales ranging from 0 (indicating that the behavior is never present) to 5 or 6 (a behavior or feeling that is present very frequently or all of the time). Items 3-11, 13-15, 17, and 18 are reverse-scored in order to ensure that higher scores indicate greater levels of motivation and energy. All items use either a 5- or 7-point Likert type response scale.	From baseline to Week 8
Change from baseline to Week 8 in DSST total score	The Digit-Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making and motor skills. The DSST is sensitive to cognitive impairments affecting attention, processing speed, and executive function (including working memory). The DSST consists of 133 digits and requires the subject to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted. The total score is the number of correct symbols and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning).	From baseline to Week 8
Change from baseline to Week 8 in ODQ domain scores (NC, ED, PR, GR, and AC)	The Oxford Depression Questionnaire (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
Change from baseline to Week 8 in MADRS total score	The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.	From baseline to Week 8
Change from baseline to Week 8 in SDS individual item scores (family, work, and social life)	Sheehan Disability Scale (SDS) measures disability. Total scores are computed by summing scores from all 3 items. Total score ranges from 0 to 30, with higher scores indicating greater disability. Reduction in SDS scores therefore indicates better outcome.	From baseline to Week 8
Change from baseline to Week 8 in SDS total scores	Sheehan Disability Scale (SDS) measures disability. Total scores are computed by summing scores from all 3 items. Total score ranges from 0 to 30, with higher scores indicating greater disability. Reduction in SDS scores therefore indicates better outcome.	From baseline to Week 8
Change from baseline to Week 8 in CGI-S score	The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).	From baseline to Week 8
CGI-I score at Week 8	The Clinical Global Impression - global improvement CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.	at Week 8

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Publications and helpful links

General Publications

• 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. 2022 Nov 14:S0165-0327(22)01292-7. doi: 10.1016/j.jad.2022.11.033. Online ahead of print.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2019
• Primary Completion (Actual): February 21, 2020
• Study Completion (Actual): February 21, 2020

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Vortioxetine
• Other Study ID Numbers: 17797A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No