Status:
TERMINATED
Treatment Study of Bipolar Depression
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Bipolar Disorder
Eligibility:
All Genders
21-70 years
Phase:
PHASE4
Brief 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.
Detailed Description
Bipolar disorder (BPD) is a common, recurrent, and disabling medical condition. Although mania is the defining feature of BPD, depression represents the majority of illness burden in patients with thi...
Eligibility Criteria
Inclusion
- Male or female patients, 21-70 years;
- Primary diagnosis of bipolar I or II disorder as assessed by the SCID-P and confirmed by a study psychiatrist;
- Current depressive episode ≥ 8 weeks duration;
- 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);
- Subjects must be on a stable dose of divalproex ER with serum levels greater than 55 mcg/ml prior to enrollment;
- 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);
- Subjects must have scored ≥ 32 on the IDS-C30 at both Screening and Infusion Day #1 and #2;
Exclusion
- 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, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
- Current presence of psychotic, mixed or manic symptoms;
- Lifetime history of antidepressant-induced switch to a manic episode;
- History of rapid cycling bipolar subtype;
- Drug or alcohol abuse within the preceding 3 months or dependence within the preceding 5 years;
- Lifetime exposure to ketamine or phencyclidine;
- Patients judged by study investigator to be at high risk for suicide.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00947791
Start Date
July 1 2009
End Date
October 1 2009
Last Update
May 17 2017
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029