Project details

Summary

What is the study about? What are you trying to find out?

The purpose of this study is to look at whether the study drug, NBI-1065845, works to improve depression symptoms when taken with your current antidepressants. You can take part in this study if you are currently on antidepressants that are not working well enough. The study drug will be compared with a placebo (which looks like the study drug but contains no active ingredients). 

This investigational drug being studied for the treatment of depression is NBI-1065845. The use of NBI-1065845 to treat depression is not approved by the U.S. Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), or any other regulatory authority worldwide.

The full study title is: 'AMPA NOVA-3: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI 1065845 as Adjunctive Treatment in Subjects with Major Depressive Disorder (MDD)'. The purpose of this research study is to look at:

• Whether the study drug works to improve depression symptoms when taken with study participants’ current antidepressants.
• How well the body can handle taking the study drug.

The study drug was already tested in previous studies of healthy participants and participants with depression. The most common side effects which occurred with NBI-1065845 in both healthy volunteers and depression participants include: headache, sleepiness, dizziness, diarrhoea (loose stools), common cold.

Who is it for?

You are being asked to participate in this research study because you are at least 18 years of age, have been diagnosed with depression and your depression symptoms have not improved with your current treatment.

Approximately 200 people will participate in this study at approximately 50 sites across the United States, the United Kingdom and Europe.

What does taking part involve?

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

The study will last for 12-14 weeks with 5 study centre visits and 3 virtual visits (conducted through virtual phone call or video call). The main activities include: signing and dating this consent form; performing tests to check your health throughout the study such as physical exams, electrocardiogram (ECG) testing, and blood and urine tests; taking the study drug daily; and completing questionnaires/scales/interviews about your symptoms.

If you are enrolled in the study, you will be randomly assigned by a computer to receive either NBI-1065845 or placebo. The placebo looks like NBI-1065845, but does not contain any active material. Placebos are commonly used in research studies to help understand if the drug being researched is effective. There is a 50% chance (like the flip of a coin) you will receive placebo. The term “study drug” will be referred to in this form and could refer to NBI-1065845 or placebo. Whichever study drug you are receiving, you will continue to receive it for the entire study. 

The entire study consists of up to 8 study visits as follows:

• Screening Period – lasts up to 4 weeks (completed over one or more study centre visits)
• 8 Week Study Drug Period – Double-Blind, Placebo-Controlled (Day 1 to Day 56)
• 2 Week Follow-Up Period – Final study visit (Day 70)

You will have the option to complete Visits 4, 6 and 8, through a virtual phone call or video call, as the study assessments planned at these visits can be completed remotely. If a virtual visit is not feasible, you can still attend your visit at the study centre. It may be recommended that you visit the study centre for follow-up if additional testing is required per the study doctor.

Participants who have completed the 8-week Treatment Period may continue into a long-term open-label (means both the patient and the study doctor will know which treatment is being given) safety study. You will be compensated for your time: £145 per completed study visit. You will not be compensated for visits that you do not complete. You will be paid per visit. Please ask the study staff any questions you may have about compensation. You may be eligible to receive reimbursement to assist with travel expenses and meals. This could be in the form of arranging travel for you or reimbursing the cost of reasonable travel expenses. The site staff will discuss your eligibility to receive reimbursement for these expenses. 

Why is it important? 

There may be no direct benefit to you from your participation in this study. The symptoms of your depression may improve, worsen or stay the same. Information learned from this study may help other people with depression in the future.

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, click the button below to email the research team:

Email the research team