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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Vortioxetine
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vortioxetine

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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.
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.
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.
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).
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.

Full Information

First Posted
February 7, 2019
Last Updated
March 23, 2020
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03835715
Brief Title
Study With Vortioxetine on Emotional Functioning in Patients With Depression
Acronym
COMPLETE
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
February 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vortioxetine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Other Intervention Name(s)
Brintellix ®
Intervention Description
Flexible doses (10-20 mg) of vortioxetine; 10 mg during the first week which may be increased up to 20 mg week 2-8
Primary Outcome Measure Information:
Title
Change from baseline to Week 8 in Oxford Depression Questionnaire (ODQ) total score
Description
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.
Time Frame
From baseline to Week 8
Secondary Outcome Measure Information:
Title
Change from baseline to Week 8 in MEI total score.
Description
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.
Time Frame
From baseline to Week 8
Title
Change from baseline to Week 8 in DSST total score
Description
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).
Time Frame
From baseline to Week 8
Title
Change from baseline to Week 8 in ODQ domain scores (NC, ED, PR, GR, and AC)
Description
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.
Time Frame
From baseline to Week 8
Title
Change from baseline to Week 8 in MADRS total score
Description
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.
Time Frame
From baseline to Week 8
Title
Change from baseline to Week 8 in SDS individual item scores (family, work, and social life)
Description
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.
Time Frame
From baseline to Week 8
Title
Change from baseline to Week 8 in SDS total scores
Description
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.
Time Frame
From baseline to Week 8
Title
Change from baseline to Week 8 in CGI-S score
Description
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).
Time Frame
From baseline to Week 8
Title
CGI-I score at Week 8
Description
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.
Time Frame
at Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Office of Dr. Patrick Bourgoin (FR0011)
City
Angoulême
Country
France
Facility Name
Cabinet Psyche (FR0012)
City
Douai
Country
France
Facility Name
Dr. David Modavi Md, Office Of (FR0001)
City
Toulouse
Country
France
Facility Name
Private Practice Dr. Paule Khalifa (FR0010)
City
Toulouse
Country
France
Facility Name
GHS De Nancy - CPN Laxou (FR0006)
City
Vandœuvre-lès-Nancy
Country
France
Facility Name
Dr Karim Boutayeb MD, Office of (FR0009)
City
Viersat
Country
France
Facility Name
Centre Medical Ambroise Pare (FR0007)
City
Élancourt
Country
France
Facility Name
DSM Giulianova c/o ospedale di Giulianova (IT0004)
City
Giulianova
Country
Italy
Facility Name
Dipartimento Salute Mentale ASL Lecce (IT0006)
City
Lecce
Country
Italy
Facility Name
Universita degli Studi di Roma La Sapienza - Azienda Ospedaliera Sant Andrea (IT0013)
City
Rome
Country
Italy
Facility Name
JSC Romuvos Klinika (LT0002)
City
Kaunas
Country
Lithuania
Facility Name
Mental Health Centre Kaunas Outpatient Clinic (LT0005)
City
Kaunas
Country
Lithuania
Facility Name
JSC Nefridos klinika (LT0006)
City
Klaipėda
Country
Lithuania
Facility Name
Jsc Silutes Mental Health And Psychotherapy Center (LT0001)
City
Silute
Country
Lithuania
Facility Name
Antakalnis Psychiatric Consultation Centre (LT0003)
City
Vilnius
Country
Lithuania
Facility Name
PI Mental Health Center of Zirmunai (LT0004)
City
Vilnius
Country
Lithuania
Facility Name
Hospital Universitario Fundacion Alcorcon (ES0009)
City
Alcorcón
Country
Spain
Facility Name
Instituto Internacional de Neurociencias Aplicadas (ES0004)
City
Barcelona
Country
Spain
Facility Name
Centro De Salud Mental De Foios (ES0002)
City
Foios
Country
Spain
Facility Name
University of Oviedo (ES0011)
City
Oviedo
Country
Spain
Facility Name
Francesca Canellas Dols (ES0005)
City
Palma De Mallorca
Country
Spain
Facility Name
Hospital Clínico Universiatrio de Salamanca (ES0001)
City
Salamanca
Country
Spain
Facility Name
Centro De Especialidades A Doblada (ES0006)
City
Vigo
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36395989
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.
Results Reference
derived
PubMed Identifier
34378539
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.
Results Reference
derived

Learn more about this trial

Study With Vortioxetine on Emotional Functioning in Patients With Depression

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