Summary:
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.
Criteria:- 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.