Study in Major Depressive Disorder With BTRX-335140 vs Placebo

A Phase 2a, Randomized, Double-blind, Placebo-controlled Proof of Concept Study to Evaluate the Effects of Oral BTRX-335140 Versus Placebo in Subjects With Major Depressive Disorder

Trial ID: NCT04221230

About the Study

In the United States, more than 20 million people are affected by MDD and depression. It is a common and serious disease that negatively affects how you feel, the way you think and how you act. Depression causes feelings of sadness, loss of interest in activities or relationships, and anxiety. It can lead to different emotional and physical problems that can limit a person’s ability to function at work and at home.

The KORAL MDD study will evaluate the safety and effectiveness of a study drug (BTRX-335140) for those who have major depressive disorder. The goal of the treatment is to help participants reduce feelings of depression and lack of pleasure.

How long will the study last?

Participants will have 6 to 10 study visits over the course of about 14 to 16 weeks. During these visits, study physicians will assess your vital signs and track your progress over time. There will also be a telephone follow up interview and a vision test conducted at the end of the treatment.

Estimated Enrollment

180

Phase

What will happen during the study?

Participants will be assigned to two groups. One group will take the study drug, and the other will take a placebo. The placebo will look like the investigational medication but will not contain any active ingredients. Participants have a 50% chance of receiving the placebo. Participants will visit the study clinic to provide health assessments and update study physicians about progress.

The impact on MDD symptoms of both groups will be compared. This comparison helps give an accurate idea of the effectiveness of the study medication. Study physicians will assess the changes in participants’s mood, ability to experience pleasure, and anxiety.

Qualified participants will receive all study visits, exams, and treatment at no cost. Compensation for time and travel may be available. Speak with study site to learn more.

Eligibility Criteria

Inclusion Criteria:

This research study is for adults who:

Are ages 18 – 65 years old
Have a diagnosis of Depression (MDD), with reduced ability to experience happiness and pleasure
Have experienced symptoms of depression for at least 3 weeks but not more than 12 months
Body mass index (BMI) between 18-40 kg/m2

Exclusion Criteria:

This research study is not for adults who:

Have had prior seizures
Are actively suicidal
Pregnant or lactating females
Have a history of serious head injury
Have a history of substance or alcohol use disorder

This trial is not actively recruiting.