Standard of Care for Major Depressive Disorder

(VENTURA-RWE Trial)

Not currently recruiting at 124 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Janssen Research & Development, LLC

Must be taking: SSRIs, SNRIs

Disqualifiers: Psychotic disorders, Bipolar, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to learn more about individuals with major depressive disorder (MDD) who experience anhedonia and do not receive sufficient relief from their current antidepressant medications. The trial examines how these individuals are treated and evaluates the effectiveness of treatments over time. It involves reviewing medical records of participants who are adding another treatment to their existing regimen. Those experiencing moderate to severe depression, who have tried antidepressants like SSRIs or SNRIs without sufficient success, and are seeking to add a new treatment might be suitable candidates.

As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications for this trial?

The trial does not specify that you need to stop your current medications. It involves adding a new treatment to your existing antidepressant, unless you are part of a specific group in the U.S. that switches to a new single antidepressant.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to gather valuable data on patients with major depressive disorder (MDD) who experience anhedonia, a condition where individuals find little joy in activities they used to enjoy. This trial focuses on those who haven't responded well to typical antidepressant treatments like SSRIs and SNRIs. By collecting detailed information from patients' medical records over a year, researchers hope to understand better why some patients don't respond to these standard treatments and potentially identify more effective future strategies.

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

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)

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Data will be collected from participants' source medical records from routine clinical practice

12 months

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• No Intervention

How Is the Trial Designed?

Group I: MDD Participants With Anhedonia Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University