Intranasal Ketamine in Treatment-Resistant Depression

Inclusion criteria

• Male or female patients, 21-65 years;
• Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study;
• Primary diagnosis of major depressive disorder as assessed by the SCID-P;
• Current depressive episode;
• History of a failure to respond to at least one (1) adequate pharmacotherapy trials in the current major depressive episode;
• Subjects must have scored ≥ 30 on the IDS-C30 at Screening ≥ 24 at Treatment Day #1 and #2;
• Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document;
• Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact.

Exclusion criteria

• Women who plan to become pregnant, are pregnant or are breast-feeding;
• Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
• Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
• Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
• Drug or alcohol abuse or dependence within the preceding 6 months;
• Lifetime abuse or dependence on ketamine or phencyclidine;
• Patients judged by study investigator to be at high risk for suicide.
• Previous participation in a ketamine study at Mount Sinai