VENTURA-RWE: A Study in Participants With Major Depressive Disorder (MDD) With Anhedonia and Inadequate Response to Current Antidepressant Therapy Including a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI)
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the socio-demographic, disease-related and treatment-related characteristics, and the standard of care (SOC) treatment patterns of participants with major depressive disorder (MDD) with anhedonia with inadequate response to their current antidepressant treatment and treated according to the standard of care treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| MDD Participants With Anhedonia Data will be collected, for major depressive disorder (MDD) participants with anhedonia who have had an inadequate response to a standard of care (SOC) antidepressant treatment, from participant's source medical records from routine clinical practice over a period of 12 months. |
Other: No Intervention
There is no interventional treatment administered to the participants as a part of this study.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants with Socio-demographic Characteristics [Day 1]
Percentage of participants with socio-demographic characteristics will be reported.
- Percentage of Participants with Disease-related Characteristics [Day 1]
Percentage of participants with disease-related characteristics which includes diagnosis/ disease history and psychiatric/ general medical comorbidities, will be reported.
- Percentage of Participants with Naturalistic Treatment Patterns [Day 1]
Percentage of participants with naturalistic treatment patterns within routine clinical practice and longitudinal course of treatment history and Pharmacological and non-pharmacological antidepressant treatments will be reported.
- Time to Next Antidepressant Treatment [Up to 12 months]
Time to next antidepressant treatment will be reported.
- Percentage of Participants with Recurrence or Relapse [Up to 12 months]
Percentage of participants with recurrence or relapse will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Meets the diagnostic criteria for single episode or recurrent major depressive disorder (MDD) without psychotic features, according to either the tenth revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) or the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
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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 (>=) 22 at entry
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Is initiating or is planning to initiate a new antidepressant treatment per local prescribing information to treat the current depressive episode. In the context of this observational study, a new antidepressant treatment is considered any new pharmacological or non-pharmacological treatment that is prescribed in addition to the current antidepressant treatment, inclusive of an selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI or SNRI) with the intent to improve a participant's clinical depressive syndrome. Accordingly, any dose escalation of an antidepressant prescribed prior to baseline or the addition of any drug intended to increase the plasma-concentration of an antidepressant prescribed prior to baseline is not considered a new antidepressant treatment
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Must sign (or their legally acceptable representative) an informed consent form indicating that he or she understands the purpose of the study and that he or she agrees to have their data collected and analyzed, in accordance with local requirements and the study protocol
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Meets the criterion for inadequate response to a current antidepressant treatment that includes an SSRI or SNRI (monotherapy SSRI, monotherapy SNRI, combination of antidepressants that includes SSRI/SNRI or SSRI/SNRI augmentation), administered at an adequate dose (as defined in the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire [MGH ATRQ]) and duration (at least 6 weeks) in the current episode of depression
Exclusion Criteria:
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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
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Participants who require an antidepressant (SSRI/SNRI) change (switching strategy)
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Unstable medical condition identified as a medical hospitalization in the past 6 months or a new medication for a medical condition in the past 3 months
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Has lack of treatment response to the current antidepressant therapy that includes a SSRI/SNRI (that is, no symptomatic improvement despite adequate dose and duration of the antidepressant treatment) assessed using the MGH ATRQ
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History of dementia or mild cognitive impairment in the past 5 years. Physician's clinical judgment should document that participant is capable of complying with observational study requirements and being able to complete the appropriate scales
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Has homicidal ideation/intent or is at imminent risk of suicide per the physician's clinical judgment and/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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Interventional Psychiatry of Tampa Bay | Tampa | Florida | United States | 33629 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109332
- 67953964MDD3004