Clinical Trial 45972

Garden Grove, CA 92845


A proof of concept (POC) study evaluating the impact of BTRX-335140 relative to placebo on symptoms of major depressive disorder (MDD) in adult subjects with MDD and symptoms of anhedonia and anxiety following 8 weeks of double-blind treatment as assessed by the HAMD-17 Scale.

  • Are adult men or women 25 to 65 years of age (inclusive) at informed consent, who provide informed consent by signing the appropriate ICFs
  • Have a primary DSM-5 diagnosis of MDD, with prominent symptoms of anhedonia confirmed by Structured Clinical Interview for DSM Disorders, Clinical Trials Version (SCID-CT)
  • Meet the algorithm-based clinical scale criteria
  • Body mass index between 18 to 35 kg/m2
  • Medically stable (in the opinion of the investigator and Sponsor/Sponsors delegate) based on medical history, vital signs, clinical laboratory tests, and 12-lead ECG performed at screening and baseline
  • Agree to birth control
  • Willing and able to give written informed consent to participate
  • Able to understand and comply with instructions in English
  • Are judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures, including venipuncture, and examinations required by the protocol

Qualified Participants May Receive:

Monetary compensation for participating.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.