Treatment Study of Bipolar Depression

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder, Depression, Treatment-Resistant, ketamine, antidepressant, glutamate Read More

Inclusion Criteria:

1. Male or female patients, 21-70 years;
2. Primary diagnosis of bipolar I or II disorder as assessed by the SCID-P and confirmed by a study psychiatrist;
3. Current depressive episode ≥ 8 weeks duration;
4. History of a failure to respond to at least three (3) adequate pharmacotherapy trials in the current depressive episode (see above for definition for adequate trials);
5. Subjects must be on a stable dose of divalproex ER with serum levels greater than 55 mcg/ml prior to enrollment;
6. Subjects must be free of psychotropic medication for at least 2 weeks (4 weeks for fluoxetine) prior to enrollment (with the exception of divalproex ER as above);
7. Subjects must have scored ≥ 32 on the IDS-C30 at both Screening and Infusion Day #1 and #2;

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, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
5. Current presence of psychotic, mixed or manic symptoms;
6. Lifetime history of antidepressant-induced switch to a manic episode;
7. History of rapid cycling bipolar subtype;
8. Drug or alcohol abuse within the preceding 3 months or dependence within the preceding 5 years;
9. Lifetime exposure to ketamine or phencyclidine;
10. Patients judged by study investigator to be at high risk for suicide.