Treatment Study of Bipolar Depression

• Status: Terminated
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether a single intravenous administration of an N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar depression.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai; Murrough, James, M.D.
• Collaborator: Icahn School of Medicine at Mount Sinai
• Treatments: Ketamine; Midazolam

Criteria

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.