Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
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What is depression?
Depression is more than feeling sad for a few days. It is a medical condition where low mood, loss of interest, and low energy last for weeks and get in the way of daily life. It is not a sign of weakness. About 21 million adults in the US, roughly 1 in 12, have at least one major depressive episode each year, and it affects women more often than men. Among teens it is even more common, about 1 in 5. Depression can start at any age, but it often first appears in the late teens to mid 20s. Scientists no longer see it as a simple chemical imbalance. Research points to a mix of genes, biology, life stress, anxiety and psychological factors.
A few things make depression studies unusual. More than 30 antidepressant medicines carry FDA approval, so this is not a field with an empty shelf. The real push now is toward treatments that work in genuinely new ways. Depression trials are also harder to run than most, because many participants improve on placebo, closer to 4 in 10 in a typical antidepressant trial. And only about 6 in 10 adults who have a major depressive episode get any treatment at all.
Interested in learning more about depression treatment? Read our guide: Depression Treatment Options: Approved and Researched
Can depression be cured?
There is no guaranteed cure for depression, but it is among the most treatable mental health conditions, and most people who get treatment see their symptoms improve. Finding the right approach can take time, and when standard treatment does not help enough, doctors call it treatment resistant depression. That group is where much of today's research effort goes. If your medication is not helping, our article on what to do when depression medication is not enough is a good place to start.
Types of depression, and why they matter for trials
Major depressive disorder. Episodes of low mood or loss of interest lasting two weeks or more with changes in sleep, energy, and concentration; the condition most trials enroll.
Treatment resistant depression. Depression that has not improved after two adequate antidepressant courses; the target of esketamine, brain stimulation, and most new medicine trials. Our guide explains what to do when antidepressants are not working.
Persistent depressive disorder. Milder but lasting two years or more; studied less often but included in some therapy trials.
Depression with anxiety. Very common together; many trials accept both, and some are designed for the combination. See anxiety clinical trials.
Postpartum and bipolar depression. Studied separately because treatments differ; see postpartum depression and bipolar disorder.
Types of treatments tested in depression clinical trials
Depression clinical trials test a wide range of treatments to identify effective strategies for managing and overcoming depression. These treatments fall into several categories:
Investigating new medications
Depression clinical trials often focus on new medications that target different aspects of brain chemistry than current antidepressants. These trials aim to find drugs with fewer side effects, quicker onset of action, and effectiveness in patients who have not responded to existing treatments.
Exploring psychotherapy methods
Clinical trials also explore various psychotherapy approaches to treating depression, including cognitive-behavioral therapy (CBT), interpersonal therapy (IPT), and newer methods. These studies aim to determine which therapies are most effective for different types of depression, alone or in combination with medication, contributing to more tailored and effective treatment plans.
Evaluating lifestyle and alternative treatments
In addition to traditional treatments, some depression clinical trials investigate the impact of lifestyle changes and alternative treatments on depression symptoms. This includes dietary modifications, exercise programs, and the use of supplements or non-traditional therapies like acupuncture or meditation. These trials seek to understand how holistic approaches can complement conventional treatments and support overall mental health.
Who can participate in clinical studies for depression?
Every study has its own entry rules, called eligibility criteria. Depression has no staging system, so studies sort people by severity instead, usually with a short symptom questionnaire, and by what treatments you have already tried. Some studies on this page look for mild or moderate symptoms. Others focus on treatment resistant depression, which means past treatments have not helped enough. There are also studies for specific groups, like teens, parents, or people who have depression alongside another illness such as Parkinson's disease. Researchers also welcome participants from communities that have been underrepresented in past studies, since older adults and people from racial and ethnic minorities have long been missing from antidepressant research. Eligibility always varies by study.
Do depression trial participants get paid?
Some studies offer compensation for time and travel, and study related care is typically provided at no cost to participants. Compensation varies by trial and is always described during the informed consent process before you agree to anything.
Curious whether clinical trials pay participants? Here's how compensation actually works.
How to enroll in a clinical trial for depression
Enrolling in a clinical trial studying depression through our platform is a straightforward and user-friendly process. Here's how to get started:
- Identify Your Trial: Use our intuitive search bar or filter options to locate clinical trials specific to requirements. This first step simplifies the process of finding relevant research studies tailored to your needs.
- Select Your Preferred Location: To find trials conveniently located near you, simply input your preferred location into the dedicated filter bar on the left-hand side of the page.
- Explore Study Details: For in-depth information about each study, simply click the “Learn More” button. This will provide you with comprehensive details about the trial, including objectives, procedures, and eligibility criteria.
- Complete the Health Profile: After clicking on the “Get started” button you will be taken to our efficient 5-step application process to provide important health information. This helps us match you with the clinical trial that best fits your needs.
- Submit the Application: After completing the application, send it in. A clinical trial coordinator will review it and contact you regarding the possibility of participation.