A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study

Exclusion Criteria

• •1. History of substance use disorder per DSM-5 criteria, except for tobacco use disorder
• •2. History or current diagnosis of bipolar disorder, schizophrenia, schizoaffective disorders, binge eating disorder dementia, delirium, amnesia, or any other significant cognitive disorder
• •3. Posttraumatic stress disorder, obsessive compulsive disorder, or any other mental disorder (including personality disorders)
• •4. Has any medical condition for which an increase in blood pressure or intracranial pressure poses a serious risk
• •5. Female of childbearing potential without appropriate contraceptive means, pregnant or breastfeeding
• •1. Inadequate response to more than 5 treatment courses of antidepressant medication therapy during the current MDE
• •2. Current MDE for longer than 5 years.
• •3. 3\. Has a current substance use disorder or history of any substance use disorder per DSM-5 criteria within 12 months prior to Screening, except for tobacco use disorder.
• •4. Has a history or current diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorders.
• •5. Has dementia, delirium, amnesia, or any other significant cognitive disorder.
• •6. Has posttraumatic stress disorder, obsessive compulsive disorder, or any other mental disorder (including personality disorders, eating disorders, etc.).
• •7. Has any medical condition for which an increase in blood pressure or intracranial pressure poses a serious risk.
• •8. Has been randomized in Part A of this study.
• •9. Is a female of childbearing potential pregnant or breastfeeding.