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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

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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

2

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

Where to Join

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Location
Status
Integrative Clinical Trials, LLC, Brooklyn, New York, 11229, United States
Recruiting
NoesisPharma, LLC, Phoenix, Arizona, 85016, United States
Recruiting
Finger Lakes Clinical Research, Rochester, New York, 14618, United States
Recruiting
Alliance Research, Long Beach, CA, 90807, United States
Recruiting
Collaborative Neuroscience Network, LLC., Torrance, CA, 90502, United States
Recruiting
Schuster Medical Research Institute, Sherman Oaks, California, 91403, United States
Recruiting
Coastal Clinical Research Specialists, Fernandina Beach, FL, 32034, United States
Recruiting
Synexus, Atlanta, GA, 30328, United States
Inactive
Sooner Clinical Research, Oklahoma City, Oklahoma, 73112, United States
Recruiting
Manhattan Behavioral Medicine, PLLC., New York, New York, 10036, United States
Recruiting
Altea Research Institute, Las Vegas, Nevada, 89102, United States
Recruiting
ProScience Research Group, Culver City, California, 90230, United States
Recruiting
Hassman Research Institute, Berlin, New Jersey, 08009, United States
Inactive
Atria Clinical Research, Little Rock, AR, 72209, United States
Inactive
Midwest Clinical Research Center, Dayton, Ohio, 45417, United States
Recruiting
Atlanta Center for Medical Research, Atlanta, Georgia, 30331, United States
Recruiting
Richmond Behavioral Associates, Staten Island, New York, 10312, United States
Recruiting
Pacific Clinical Research Management Group LLC, Upland, CA, 91786, United States
Recruiting
Clinical Neuroscience Solutions, Inc., Memphis, Tennessee, 38119, United States
Recruiting
CITrials, Bellflower, CA, 90706, United States
Recruiting
Miami Lakes Medical Research Outpatient Division, Miami Lakes, FL, 33016, United States
Recruiting
Lumos Clinical Research Center, San Jose, CA, 95124, United States
Recruiting
Headlands Research Sarasota, Sarasota, FL, 34243, United States
Recruiting
iResearch Atlanta, Decatur, GA, 30030, United States
Recruiting
Behavioral Research Specialist, LLC, Glendale, California, 91206, United States
Recruiting
Pillar Clinical Research, Bentonville, AR, 72712, United States
Recruiting
Collaborative Neuroscience Network, LLC., Garden Grove, California, 92845, United States
Recruiting
Clinical Neuroscience Solutions, Inc., Jacksonville, Florida, 32256, United States
Recruiting
Clinical Neuroscience Solutions, Inc., Orlando, Florida, 32801, United States
Recruiting
West Broward Outpatient Clinic, Lauderhill, FL, 33319, United States
Recruiting
CITrials, Santa Ana, CA, 92705, United States
Recruiting
CITrials, Riverside, CA, 92506, United States
Recruiting
Alpine Research Organization, Clinton, Utah, 84015, United States
Recruiting
Atlanta Behavioral Research, LLC., Atlanta , Georgia, 30338, United States
Recruiting
Synexus Clinical Research - Queens, Jamaica, NY, 11432, United States
Inactive
Preferred Research Partners, Inc, Little Rock, AR, 72211, United States
Recruiting

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