Major Depressive DisorderPhase 4COMPLETENCT03835715
Study With Vortioxetine on Emotional Functioning in Patients With Depression
A Phase 4 study testing Vortioxetine in people with Major Depressive Disorder, run by H. Lundbeck A/S at 23 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Vortioxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 5 Feb 2019to 21 Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
France7 sites
Office of Dr. Patrick Bourgoin (FR0011)
Angoulême
Cabinet Psyche (FR0012)
Douai
Centre Medical Ambroise Pare (FR0007)
Élancourt
Dr. David Modavi Md, Office Of (FR0001)
Toulouse
Private Practice Dr. Paule Khalifa (FR0010)
Toulouse
GHS De Nancy - CPN Laxou (FR0006)
Vandœuvre-lès-Nancy
Dr Karim Boutayeb MD, Office of (FR0009)
Viersat
Spain7 sites
Hospital Universitario Fundacion Alcorcon (ES0009)
Alcorcón
Instituto Internacional de Neurociencias Aplicadas (ES0004)
Barcelona
Centro De Salud Mental De Foios (ES0002)
Foios
University of Oviedo (ES0011)
Oviedo
Francesca Canellas Dols (ES0005)
Palma de Mallorca
Hospital Clínico Universiatrio de Salamanca (ES0001)
Salamanca
Centro De Especialidades A Doblada (ES0006)
Vigo
Lithuania6 sites
JSC Romuvos Klinika (LT0002)
Kaunas
Mental Health Centre Kaunas Outpatient Clinic (LT0005)
Kaunas
JSC Nefridos klinika (LT0006)
Klaipėda
Jsc Silutes Mental Health And Psychotherapy Center (LT0001)
Šilutė
Antakalnis Psychiatric Consultation Centre (LT0003)
Vilnius
PI Mental Health Center of Zirmunai (LT0004)
Vilnius
Italy3 sites
DSM Giulianova c/o ospedale di Giulianova (IT0004)
Giulianova
Dipartimento Salute Mentale ASL Lecce (IT0006)
Lecce
Universita degli Studi di Roma La Sapienza - Azienda Ospedaliera Sant Andrea (IT0013)
Rome
About this study
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
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Vortioxetine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
Also called Brintellix ®
Flexible doses (10-20 mg) of vortioxetine; 10 mg during the first week which may be increased up to 20 mg week 2-8
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine | Experimental | Not described Receives: Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to Week 8
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start5 Feb 2019
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835715
- Sponsor's protocol ID
- 17797A
- Acronym
- COMPLETE
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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. 2023 Feb 15;323:547-553. doi: 10.1016/j.jad.2022.11.033. Epub 2022 Nov 14.
PubMed 36395989Christensen 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.
PubMed 34378539
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03835715
- Acronym / sponsor ID
- COMPLETE / 17797A
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine | Experimental | Drug: Vortioxetine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VortioxetineAlso: Brintellix ®Flexible doses (10-20 mg) of vortioxetine; 10 mg during the first week which may be increased up to 20 mg week 2-8 | Drug | Vortioxetine |
Primary outcome
Change from baseline to Week 8 in Oxford Depression Questionnaire (ODQ) total score
Time frame: From baseline to Week 8
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.
8 secondary outcomes
Change from baseline to Week 8 in MEI total score.
Time frame: From baseline to Week 8
Change from baseline to Week 8 in DSST total score
Time frame: From baseline to Week 8
Change from baseline to Week 8 in ODQ domain scores (NC, ED, PR, GR, and AC)
Time frame: From baseline to Week 8
Change from baseline to Week 8 in MADRS total score
Time frame: From baseline to Week 8
Change from baseline to Week 8 in SDS individual item scores (family, work, and social life)
Time frame: From baseline to Week 8
Change from baseline to Week 8 in SDS total scores
Time frame: From baseline to Week 8
Change from baseline to Week 8 in CGI-S score
Time frame: From baseline to Week 8
CGI-I score at Week 8
Time frame: at Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 36395989Christensen 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.
- Derived from this study: PubMed 34378539Christensen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vortioxetine in people with Major Depressive Disorder, run by H. Lundbeck A/S at 23 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France, Spain, Lithuania, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to Week 8 in Oxford Depression Questionnaire (ODQ) total score (time frame: From baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03835715, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.