A Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of (R)-Ketamine Hydrochloride Nasal Spray in Patients With Depression and Acute Suicidal Ideation or Behavior

Exclusion Criteria

• •1. Participant has a current DSM-5 diagnosis of bipolar (or related disorders), antisocial personality disorder, or obsessive compulsive disorder.
• •2. Participant has a current clinical diagnosis of autism, dementia, or intellectual disability.
• •3. Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychotic features .
• •4. Participant meets the DSM-5 severity criteria for moderate or severe substance or alcohol use disorder, within the 6 months before screening
• •5. Participant has a current or prior diagnosis of a reatment resistant depression
• •6. Any nasal conditions or diseases that, in the investigator's judgment, may significantly affect the administration or absorption of a nasal product.
• •7. Participant has a history of malignancy within 5 years before screening
• •8. Pregnant or breastfeeding women, or those with a positive pregnancy test result during screening.
• •9. Previous participation in another clinical trial and receiving the investigational drug within 3 months prior to dosing.