Treatment Study of Bipolar Depression

Stopped early · Phase 4

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00947791

Run by

Icahn School of Medicine at Mount Sinai

People needed

1

Starts

2009-07-01

Expected to finish

2009-10-01

Last updated by the study team

2017-05-17

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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