A Study of CX157 (TriRima) for the Treatment of Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: CX157 (TriRima); Placebo
Intervention description: Six capsules administered three times a day for six weeks.; Six capsules administered three times a day for six weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 285.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: MDD

Summary:

      The purpose of this study is to examine the efficacy of CX157 60 mg administered three times
      a day (180 mg daily dose) as compared to placebo in subjects with Major Depressive Disorder
      (MDD). Secondary objectives are to evaluate the safety and tolerability and steady state
      pharmacokinetic profile of CX157 in these subjects.
    

Eligibility criteria:

        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