A Phase 4 interventional study of Vortioxetine in Major Depressive Disorder, sponsored by H. Lundbeck A/S. Completed at 23 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by H. Lundbeck A/S · Phase 4, Interventional, and 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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 150 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other in- and exclusion criteria may apply
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
Also known as: Brintellix ®
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.
Time frame: From baseline to Week 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: at Week 8
Plan to share: Undecided
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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H. Lundbeck A/S