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Trial record 1 of 229 for:    "Depressive Disorder" [DISEASE] | ( Map: Missouri, United States )
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Real-life Effectiveness of Vortioxetine in Depression (RELIEVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03555136
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:

Worldwide Major Depressive Disorder (MDD) has significant negative personal, societal and economic consequences.

Vortioxetine (Brintellix®) is a new antidepressant authorized since 2013. Despite evidence generated from clinical trials which demonstrate that vortioxetine is an efficacious, well-tolerated antidepressant, there is a need to determine the effectiveness of vortioxetine in real life routine practice.

The study aim is to examine the real-life effectiveness of vortioxetine on functioning, depressive symptom relief, cognition and quality of life.

This is an observational, multi-national, study in patients with MDD initiating treatment with vortioxetine. Information will be collected by the physician, from the patient and their medical record at three time points - baseline, week 12 and week 24 (end of follow-up). This study will be conducted in six countries. In total 2,100 patients are planned for enrolment.


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

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Study Type : Observational
Estimated Enrollment : 2100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-life Effectiveness of Vortioxetine in Patients With Major Depressive Disorder: Non-interventional, Multi-national, Prospective Cohort Study to Assess Real-life Effectiveness of Vortioxetine
Actual Study Start Date : November 17, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients initiating vortioxetine treatment
Patients with major depressive disorder initiating treatment with vortioxetine
Drug: Vortioxetine
Treatment with vortioxetine as per local SmPC




Primary Outcome Measures :
  1. Sheehan Disability Scale (SDS) [ Time Frame: Change since baseline at week 12 and 24 ]
    A series of patient self-rated, scales designed to measure the extent to which his or her 1) work or school, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms


Secondary Outcome Measures :
  1. The Patient Health Questionnaire - nine items (PHQ-9) [ Time Frame: Change since baseline at week 12 and 24 ]
    A patient-rated scale designed to assess depression based on the nine DSM-IV criteria for depression

  2. Perceived Deficits Questionnaire - Depression - five items (PDQ-D-5) [ Time Frame: Change since baseline at week 12 and 24 ]
    A self-reported rating scale that aims to assess perceived cognitive deficits from the patient's perspective



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Outpatients from primary, secondary or tertiary care centres
Criteria

Inclusion Criteria:

  • The patient is ≥18 years
  • The patient is an outpatient, treated in a GP or psychiatric outpatient practice
  • The patient has a diagnosis of major depressive episode according to local diagnostic criteria
  • The patient has been prescribed vortioxetine according to the local Summary of Product Characteristics (SmPC)

Exclusion Criteria:

  • The patient is unable to read and understand the information sheet and informed consent form or the Patient Reported Outcomes (PRO)
  • The patient is concurrently participating in a clinical trial
  • The patient has a diagnosis of schizophrenia or other psychotic disorder according to local diagnostic criteria
  • The patient has a diagnosis of bipolar disorder according to local diagnostic criteria
  • The patient has a substance use disorders other than tobacco use disorder
  • The patient has dementia or other neurodegenerative disease significantly impacting cognitive functioning
  • The patient has a mood disorder due to a general medical condition or substances
  • The patient is pregnant, ≤6 months post-partum or breastfeeding
  • The patient is at significant risk of suicide in the investigator's opinion or the patient has attempted suicide within the last six months
  • The patient is a member of the study personnel or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the study personnel

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): NCT03555136


Contacts
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Contact: Email contact H. Lundbeck A/S +4536301311 LundbeckClinicalTrials@lundbeck.com

Locations
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United States, Missouri
US 0039 Mattingly Recruiting
Saint Charles, Missouri, United States, 63304
Contact: Email Contact via H. Lundbeck A/S         
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com

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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT03555136     History of Changes
Other Study ID Numbers: 17354N
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vortioxetine
Antidepressive Agents
Psychotropic Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of 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-HT3 Receptor Antagonists
Serotonin Antagonists