Project details

Summary

What is the study about?

Depression is a leading cause of disability around the world and affects  approximately 280 million people. Although patients have options to treat their MDD, standard-of-care antidepressant treatments may produce an inadequate response.

Even after switching antidepressant treatments and trying adjunctive therapy, patients often fail to achieve full remission. MDD patients may continue to have symptoms such as anhedonia and fatigue.

Persistence of anhedonia has been linked to poorer outcomes in patients with MDD, including increased overall severity of depression symptoms, a chronic course of depression over a 10-year period, longer time to remission, and functional and quality-of-life impairment. 

Due to the prevalence of depression and its effects on patients’ everyday lives, it’s important to develop improved treatments for depression. The results of the VENTURA-RWE study will provide more information about MDD and the way it is currently treated.

What are you trying to find out?

The purpose of this research study is to investigate: 

• social and demographic factors
• disease-related and treatment-related characteristics
• standard of care (SOC) treatment patterns

in participants with Major Depressive Disorder (MDD) with anhedonia (reduced ability to experience interest, motivation, enjoyment, or pleasure) who have had an insufficiently improvement response to the current antidepressant treatment.

The study aim is to collect information on your well-being and how your treatments for depression help you over the next 12 months. No differing study medicine is being used in this study. You will continue to take the medications that your doctor(s) prescribes for you.

What does taking part involve?

If you join the study, your participation will last approximately 12 months. It will usually comprise 4 visits/sessions (preferably at the clinic). These will be arranged either in person or virtually to discuss routine medical care and for the completion of questionnaires. 

The Study Team will collect healthcare data from your medical records, to include medical and depression history. Current information will incorporate a review of medications, side effects and body weight. In addition, data will be obtained from questionnaires completed by you, and interviews performed by your study doctor and/or researcher.

The completion of the study-related questionnaires is optional.

This study does not require any specific testing or additional visits, but your study doctor may capture test information that is collected as part of your normal care. This study does not change the way in which your doctor delivers your care.

You will be compensated with £47 for each visit to the clinic in which the study doctor/study clinical staff collect data that will be recorded for the study. This will cover the expenses directly related to the study visits such as local travel, meals, and parking.

Additionally, if you decide to participate into Optional Reward Learning Task Testing (RLT), you will receive £24 on each visit in which you complete the RLT assessment as well.

Who is it for?

You are invited to take part in this non-interventional study because:

• you are 18 to 74 years of age,
• you have Depression (also described as Major Depressive Disorder (MDD))
• you are taking antidepressant treatment that includes an SSRI (selective serotonin reuptake inhibitor) or SNRI (serotonin and norepinephrine reuptake inhibitors)
• and you are being considered for additional treatment since the current treatment is not sufficiently improving with your symptoms.

Up to 500 participants will take part in this study from across the world. 

Why is it important? 

Due to the prevalence of depression and its effects on patients’ everyday lives, it’s important to develop improved treatments for depression. The results of the VENTURA-RWE study will provide more information about MDD and the way it is currently treated.

The data from this study may be used by the sponsor to improve and perform their other research activities upon depression.

How can I find out more?

You can find out more information about taking part in this study by downloading the key documents at the top of this page. 

If you are interested in taking part in this study, or have questions for the research team, click the button below to email us:

Email the research team