A Study of CX157 (TriRima) for the Treatment of Depression (CX157-200)

This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD Read More

Inclusion Criteria:

• Male or female = 18 years of age and <60 years
• Able to read, understand, converse in English
• Willing to comply with diet restrictions, concomitant medication restrictions, & all study requirements
• Good general health as ascertained by:Medical history, Physical exam, Supine & standing vital signs, Clinical lab evaluations, 12-lead Electrocardiogram (ECG)
• Diagnosis of MDD;
• A total score =>40 on the IDS-SR30 assessed via IVRS at Screening and Randomization

Exclusion Criteria:

• Subject's current MDD episode is >2 years
• History of Substance Use Disorder at Screening or 12 months prior (except for nicotine)

• Current diagnosis of Obsessive-Compulsive Disorder;

  • Panic Disorder or Post-Traumatic Stress Disorder;
  • Anorexia nervosa, Bulimia nervosa, or eating disorder not otherwise specified;
  • Any Axis I Disorder clinically predominant to their MDD (within 6 mo);
  • Presence of psychotic features with current depressive episode;
  • Antisocial or Borderline Personality Disorder
• At risk for suicide
• Lack of response to >2 trials of adequate dose & duration of antidepressants of different mechanistic classes
• Electroconvulsive therapy within 1 year of Screening
• Subject has taken any psychoactive drug within 2 weeks of Randomization
• History of cardiac abnormalities including abnormal vital sign measurements
• Clinically significant abnormal ECG at Screening

• History within past 2 years of: Significant head trauma;

  • Surgical procedure involving brain or meninges; Encephalitis or meningitis;
  • Degenerative CNS disorder (Alzheimer's or Parkinson's);
  • Epilepsy;
  • Mental retardation
• Clinically significant Liver Function Test (LFT) and other lab abnormalities
• A history of hypothyroidism and treatment with a stable dosage of thyroid replacement medication for <6 months prior to Screening
• A history of hyperthyroidism treated (medically or surgically) <6 months prior to Screening
• Participation in a clinical investigation of a psychotropic drug within 90 days prior to Screening OR used any other investigational drug within 60 days prior to Screening

• Presence of any medical history which includes:

  • Hypersensitivity to CX157 or excipients, other MAO inhibitors, or other phenylethylamines;
  • Diabetes mellitus Type I, uncontrolled Type II, or controlled Type II managed with insulin; Malignancy/chemotherapy within 2 years prior to Screening;
  • Malignancy >2 yrs may not preclude participation if the malignancy was local and without metastasis or recurrence and, if treated with chemotherapy, had no nervous system complications (e.g basal cell carcinoma);
  • Pheochromocytoma
• Positive urine test for drugs of abuse (blood for alcohol)
• Female subject who is pregnant or lactating
• Poor likelihood of subject's cooperation or compliance