Phase 3 Depression and Anxiety Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 65 years old (male or female)
• People who have been diagnosed with major depressive disorder (MDD) without psychosis, according to a standard psychiatric assessment tool called the M.I.N.I.
• People who are currently in a depressive episode that has lasted at least 4 weeks
• People whose depression symptoms score at a certain level of severity on two standard rating scales (MADRS score of 25 or higher, and CGI-S score of 4 or higher) at both the screening and baseline appointments
• People whose physical examination and blood/lab test results meet the trial's requirements during the screening period
• People with a Body Mass Index (BMI) between 18 and 40
• Male participants whose birth control arrangements (for themselves and their female partners) meet the trial's requirements

Who may not be able to join:

• People whose depression has not responded to two or more adequate courses of antidepressant treatment (sometimes called treatment-resistant depression) (confirm with trial site)
• People whose depression symptoms improved by 25% or more between the screening visit and the baseline visit
• People who have been admitted to a psychiatric hospital during their current depressive episode
• People who, in the investigator's judgment, have a clinically significant risk of suicide, self-harm, or harm to others
• People who test positive for substance abuse during screening
• People who have a serious or unstable medical condition affecting areas such as the heart, lungs, kidneys, liver, blood, digestive system, nervous system, or hormones, as determined by the investigator
• People with high blood pressure (hypertension)
• People with an underactive or overactive thyroid, unless their condition has been stable on the same medication dose for at least one month before screening and their thyroid hormone levels fall within a specific range
• People who are allergic to bupropion, dextromethorphan, opioids (such as codeine), or any ingredient in the study drugs
• People who have previously had a bad reaction or intolerance to bupropion or dextromethorphan
• People living with HIV, or who test positive for HIV during screening
• People who test positive for hepatitis during screening
• People whose liver function test results (including total bilirubin, AST, and/or ALT) are more than twice the upper limit of normal during screening
• People who, for any other reason, the investigator considers unsuitable for the trial

Important: Always verify eligibility with the trial site directly before applying.