Treatment-Resistant Depression Cohort in Europe

Janssen-Cilag Ltd.830 enrolled

Overview

The purpose of this study is to assess the participants socio-demographics and disease-related characteristics, long-term naturalistic treatment patterns and the clinical, social and economic outcomes of routine clinical practice in the treatment of participants with treatment-resistant depression (TRD) in a variety of European countries.

This TRD cohort study will collect critically important data from routine clinical practice in Europe which will further substantiate the understanding of TRD in European clinical practice, with the aim of improving guidance and informing the development of better treatment strategies for this medically important condition. All data recorded in the case report form (CRF) should be documented in participants' medical records, that will be the primary data source of each participant. Participants who meet the diagnostic criteria for Major Depressive Disorder (MDD) and the diagnostic criteria for TRD, and are initiating or planned to initiate a new antidepressive treatment regimen will participate in the study. The end of the entire study will be 6 months after enrollment of the last participant in the study.

Study Type

OBSERVATIONAL

Enrollment

830

Conditions

Depressive Disorder, Treatment-Resistant

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Meets the diagnostic criteria for single episode or recurrent MDD, without psychotic features, according to either the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) or the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * Is considered to suffer from a moderate or severe depressive syndrome, as defined by a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to (\>=) 20 at baseline * Meets/has met the TRD criteria, defined as lack of clinically meaningful improvement, as indicated by a Clinical Global Impression-Change (CGI-C) score \>= 4 and/or less than or equal to (\<=) 25 percent (%) improvement in MADRS total score (lack of tolerability is not an indicator of non-response), with at least 2 different oral antidepressant treatments (of the same class, of a different class, or a combination of antidepressants or antidepressant with adjunctive antipsychotics) in the current episode of depression, prescribed in adequate dosages (as defined in the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire \[MGH ATRQ\]) for adequate duration (at least 6 weeks) with adequate treatment adherence assessed by physicians * Is initiating a new antidepressive treatment to treat the current depressive episode * Must be capable of providing informed consent, based on the opinion of the participating physician Exclusion Criteria: * Has a current or prior diagnosis of a psychotic disorder, MDD with psychotic features, bipolar or related disorders, or intellectual disability, according to DSM-5 or ICD-10 * Has homicidal ideation/intent or has suicidal ideation with some intent to act, within 1 month prior to enrollment (per the physician's clinical judgment or based on the Columbia-Suicide Severity Rating Scale \[C-SSRS\] corresponding to a response of "Yes" on Item 4 \[active suicidal ideation with some intent to act, without specific plan\] or Item 5 \[active suicidal ideation with specific plan and intent\]) or a history of suicidal behavior within 1 year prior to enrollment * Has a history of moderate or severe substance use disorder or severe alcohol use disorder according to DSM 5 criteria, except for nicotine and caffeine, within 6 months prior to enrollment * Has a lifetime history of hallucinogen-related substance use disorder, with ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3,4 methylenedioxy-methamphetamine (MDMA) * Has participated in or is currently enrolled in any clinical trial or observational study within the current episode * Has previously received esketamine at any time

Locations (98)

Outcomes

Primary Outcomes

Number of Treatment Resistant Depression (TRD) Participants With Change From Baseline in Socio-demographic Characteristics

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.

Time frame: Baseline up to 21 months (end of study)

Treatment Patterns Over Time for TRD Participants

Treatment patterns (pharmacological and/or non-pharmacological) of TRD participants will be assessed over time.

Time frame: Baseline up to 21 months (end of study)

Percentage of Participants With Disease-Related Characteristics

Percentage of participants with disease-related characteristics for TRD among Major Depressive Disorder (MDD) participants will be assessed.

Time frame: Up to 21 months

Severity of Symptoms as Measured by Montgomery-Asberg Depression Rating Scale (MADRS)

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.

Time frame: Up to 21 months

Participant's Clinical Global Impression-Severity (CGI-S) Score

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.

Time frame: Up to 21 months

Data from ClinicalTrials.gov

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Hauwaert An

Bilzen, Belgium

AZ Sint-Lucas

Bruges, Belgium

C.H.U. Brugmann

Brussels, Belgium

Psy Pluriel-Pastur

Brussels, Belgium

Psychiatrisch Centrum Dr Guislain

Ghent, Belgium

CHU Sart Tilman

Liège, Belgium

Hôpital du Petit Bourgogne

Liège, Belgium

Clinique Saint Pierre

Ottignies, Belgium

St-Andries Ziekenhuis

Tielt, Belgium

Klinik f. Psychiatrie, Psychosomatik u Psychoth

Bamberg, Germany

...and 88 more locations