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Study With Vortioxetine on Emotional Functioning in Patients With Depression

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ClinicalTrials.gov Identifier: NCT03835715
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Vortioxetine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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 Name: Brintellix ®




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change from baseline to Week 8 in MEI total score. [ Time Frame: From baseline to Week 8 ]
    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.

  2. Change from baseline to Week 8 in DSST total score [ Time Frame: From baseline to Week 8 ]
    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).

  3. Change from baseline to Week 8 in ODQ domain scores (NC, ED, PR, GR, and AC) [ Time Frame: From baseline to Week 8 ]
    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.

  4. Change from baseline to Week 8 in MADRS total score [ Time Frame: From baseline to Week 8 ]
    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.

  5. Change from baseline to Week 8 in SDS individual item scores (family, work, and social life) [ Time Frame: From baseline to Week 8 ]
    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.

  6. Change from baseline to Week 8 in SDS total scores [ Time Frame: From baseline to Week 8 ]
    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.

  7. Change from baseline to Week 8 in CGI-S score [ Time Frame: From baseline to Week 8 ]
    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).

  8. CGI-I score at Week 8 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835715


Contacts
Contact: Email contact via H. Lundbeck A/S +45 36301311 LundbeckClinicalTrials@Lundbeck.com

Locations
Spain
Instituto Internacional de Neurociencias Aplicadas (ES0004) Recruiting
Barcelona, Spain
Francesca Canellas Dols (ES0005) Recruiting
Palma De Mallorca, Spain
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT03835715     History of Changes
Other Study ID Numbers: 17797A
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vortioxetine
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT1 Receptor Antagonists
Serotonin Antagonists
Serotonin 5-HT3 Receptor Antagonists