Intranasal Ketamine in Treatment-Resistant Depression

Inclusion Criteria:

1. Male or female patients, 21-65 years;

2. Women of childbearing potential must agree to use a medically accepted means of
contraception for the duration of the study;

3. Primary diagnosis of major depressive disorder as assessed by the SCID-P;

4. Current depressive episode;

5. History of a failure to respond to at least one (1) adequate pharmacotherapy trials
in the current major depressive episode;

6. Subjects must have scored ≥ 30 on the IDS-C30 at Screening ≥ 24 at Treatment Day #1
and #2;

7. 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;

8. 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:

1. Women who plan to become pregnant, are pregnant or are breast-feeding;

2. Any unstable medical illness including hepatic, renal, gastroenterologic,
respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic
disease;

3. Clinically significant abnormal findings of laboratory parameters, physical
examination, or ECG;

4. Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD,
mental retardation, pervasive developmental disorders, or Tourette's syndrome;

5. Drug or alcohol abuse or dependence within the preceding 6 months;

6. Lifetime abuse or dependence on ketamine or phencyclidine;

7. Patients judged by study investigator to be at high risk for suicide.

8. Previous participation in a ketamine study at Mount Sinai