Treatment-Resistant Depression Cohort in Europe
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|ClinicalTrials.gov Identifier: NCT03373253|
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : April 8, 2019
|Condition or disease|
|Depressive Disorder, Treatment-Resistant|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Treatment-Resistant Depression Cohort in Europe|
|Actual Study Start Date :||February 13, 2018|
|Estimated Primary Completion Date :||December 10, 2019|
|Estimated Study Completion Date :||December 10, 2019|
Participants With Diagnosis of Depression
This study will evaluate participant's socio-demographic, disease-related and treatment-related characteristics along with outcomes in routine clinical practice across the European region. Only data available within clinical practice, through routine therapeutic procedures and diagnostic assessments, will be recorded. Individual participant information will be recorded from participant's medical records or by use of specific questionnaires.
- Number of Treatment Resistant Depression (TRD) Participants With Change From Baseline in Socio-demographic Characteristics [ Time Frame: Baseline up to 21 months (end of study) ]Number of TRD participants with change from baseline in socio-demographic characteristics (education, occupational status, living status, economic status, marital status, legal status) will be assessed.
- Treatment Patterns Over Time for TRD Participants [ Time Frame: Baseline up to 21 months (end of study) ]Treatment patterns (pharmacological and/or non-pharmacological) of TRD participants will be assessed over time.
- Percentage of Participants With Disease-Related Characteristics [ Time Frame: Up to 21 months ]Percentage of participants with disease-related characteristics for TRD among Major Depressive Disorder (MDD) participants will be assessed.
- Severity of Symptoms as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Up to 21 months ]The MADRS is a clinician-rated scale designed to measure changes in depression severity due to antidepressant treatment.The MADRS consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms) for a total possible score of 60. Higher scores represent a more severe condition.
- Participant's Clinical Global Impression-Severity (CGI-S) Score [ Time Frame: Up to 21 months ]The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.
- Participant's Clinical Global Impression-Change Scale (CGI-C) [ Time Frame: Up to 21 months ]The CGI-C is a clinician-rated 7 point scale, ranging from 1 (very much improved) to 7 (very much worse). The CGI C scale will be used in this study to assess any improvement or worsening in a participant's condition versus previous assessments.
- Healthcare Resource Utilization in TRD Participants [ Time Frame: Up to 21 months ]Healthcare resources utilized in TRD participants will be estimated.
- European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire [ Time Frame: Up to 21 months ]The EQ-5D-5L descriptive system comprises 5 dimensions - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression - each of which is divided into 5 levels of perceived problems (Level 1 indicating no problem, Level 2 indicating slight problems, Level 3 indicating moderate problems, Level 4 indicating severe problems, and Level 5 indicating extreme problems).
- Quality of Life in Depression Scale (QLDS) [ Time Frame: Up to 21 months ]The QLDS is a disease-specific PRO used to document the impact that depression has on a participant's quality of life. The QLDS is a 34-item self-rated questionnaire consisting of dichotomous response questions, with responses being either True/Not True or Yes/No. It is scored binomially (that is, 0 or 1), with high scores on the QLDS indicating a lower quality of life.
- Work Productivity and Activity Impairment (WPAI) [ Time Frame: Up to 21 months ]The WPAI produces 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment. The WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
- Level of Disability as Sheehan Disability Scale (SDS) [ Time Frame: Up to 21 months ]Participant-reported outcome of functional impact and associated disability will be documented by use of the SDS, a 5-item questionnaire. The first 3 items of the SDS document disruption of work/school, social life, and family life/home responsibilities, each using a rating from 0 to 10. The scores for the first 3 items are summed to create a total score of between 0 and 30, a higher score indicative of greater impairment. It also has 1 item on days lost from school or work and 1 item on days when underproductive.
- Sequence of Treatments in Participants with TRD [ Time Frame: Up to 21 months ]Treatment sequences for participants with TRD within routine clinical care in Europe will be assessed.
- Demographic Characteristics of TRD Participants [ Time Frame: Baseline ]Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline.
- Suicidality Risk (Ideation and Attempts) as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Score [ Time Frame: Baseline ]Suicidal ideation or behavior will be measured using C-SSRS score. C-SSRS is a clinician rated assessment of suicidal behavior and/ or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
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): NCT03373253
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
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|Study Director:||Janssen-Cilag Ltd. Clinical Trial||Janssen-Cilag Ltd.|