Efficacy Study of RX-10100 to Treat Major Depressive Disorder (MDD)

Exclusion Criteria

• •Have a BMI \> 40 or \< 18
• •Unstable angina pectoris
• •History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months
• •Uncontrolled atrial fibrillation/flutter at screening
• •Severe chronic or acute liver disease; history of moderate or severe hepatic impairment
• •Clinically significant chronic hematological disease which may lead to priapism, such as sickle cell anemia and leukemia
• •Bleeding disorder
• •Resting hypotension or hypertension
• •History of malignancy (cancers) within the past 5 years (other than squamous or basal cell skin cancer)
• •NYHA Class III or IV heart failure
• •Substance abuse/dependence within the past 6 months
• •Significant suicidal ideation based on the C-SSRS
• •Other current nondepressive Axis I disorders
• •Depressive episode duration of less than 1 month or greater than 9 months
• •Bipolar disorder
• •Dysthmic disorder
• •Borderline personality disorder
• •Psychotic disorder/current psychotic features
• •Any abnormal findings on the screening ECG judged clinically significant by the Investigator
• •Any medical condition that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the Investigator
• •Any history of cholestatic jaundice or liver cirrhosis
• •Hyper- or hypothyroidism unless the subject has received a stable dose of thyroid medication for at least 3 months prior to the screening visit
• •Women, who are breast-feeding, have been lactating within 3 months prior to screening
• •Concurrent psychotherapy
• •Subjects who have received any other investigational drug (including placebo) within 30 days before Visit 1
• •Use of any treatment for MDD within 7 days of Visit 1 (14 days for fluoxetine) and during the study other than the study medication
• •Use of antidepressants, anxiolytics, or other psychoactive drugs within 14 days of Visit 1 and during the study
• •Concomitant use of antibiotics in the penicillin class (for the reduction of the potential for any additive or synergistic hepatotoxicity)
• •A positive urine drug screen
• •Elevation of AST and/or ALT \> 3 times the upper limit of normal (ULN)
• •Diabetic subjects with an HbAlc ≥ 12%
• •Any abnormal screening laboratory values judged clinically significant by the Investigator
• •Previous nonresponse or hypersensitivity to two or more trials of antidepressant medication given in adequate doses and duration for the treatment of symptoms present in the current illness
• •Subjects with known hypersensitivity to any antibiotic in the penicillin class
• •Subjects who are illiterate or unable to understand the questionnaires
• •Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule of study procedures
• •Subjects who pose potential harm to others