No intervention
OtherThere is no interventional treatment administered to the participants as a part of this study.
NCT Number: NCT05841030
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 treatments and treated according to the standard of care treatment.
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Notify Me18 year–74 year
All sexes
Observational
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
There is no interventional treatment administered to the participants as a part of this study.
Time frame: Day 1
Distribution of participants with different demographic characteristics will be assessed.
Time frame: Day 1
Percentage of participants with disease-related characteristics which includes diagnosis/ disease history and psychiatric/ general medical comorbidities, will be reported.
Time frame: Day 1
Percentage of participants with type of therapies (such as augmentation, combination therapy, etc.) and treatment strategies will be reported.
Time frame: Up to 12 months
Time to next antidepressant treatment will be reported.
Time frame: Up to 12 months
Percentage of participants with recurrence or relapse will be reported.
Time frame: Baseline, up to 12 months
Change from baseline in CSFQ-14 total score will be reported. The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items). Each question rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning.
Time frame: Up to 12 months
Percentage of participants with PGI-S scale score for sexual functioning will be reported. The PGI-S is a self-administered, single item questionnaire measuring patients' impression of disease severity. Participants will be asked to rate their disease severity using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe. Higher scores indicate greater disease severity.
Janssen Research & Development, LLC
Industry
A Study of Disease Characteristics and Real-life Standard of Care Effectiveness in Patients With Major Depressive Disorder (MDD) With Anhedonia and Inadequate Response to Current Antidepressant Therapy Including an SSRI or SNRI
Acronym: VENTURA-RWE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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