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Awarded Trial: 98-RC-301-3

Grant ID

98-RC-301-3

Illness

Bipolar Disorder

Primary Drug/Intervention

Prednisone

Primary Dosage

N/A

Secondary Drug Intervention

N/A

Secondary Dosage

N/A

Other Drug/Intervention

N/A

Other Dosage

N/A

Status

Completed

Investigator

Rush

Sample Size

30

Duration of Study Period for Each Subject

N/A

Outcome Measurements

N/A

Results

Some data suggest that over time, mood episodes in bipolar disorder increase in severity and frequency and are less likely to be precipitated by environmental stressors. Mood changes with corticosteroids appear to provide a model for bipolar disorder by producing very mild but significant hypomanic-like symptoms. The purpose of this study is to determine if exposure to multiple courses of cortcosteroids leads to a sensitization or kindling phenomenon in which mild and transient hypomanic-like symptoms become more severe. Each participant is assessed at days 1, 3, 15, 17, 29, 31, and 43 with the 21-item Hamilton Depression Scale, the 11-item Young Mania Scale, the 16-item Internal State Scale and one of seven versions of the Reading and Vocabulary Learning Test. On days 1, 15, and 29 participants are randomized to either a 3 day course of prednisone 60mg per day or a 3 day course of placebo. each participant receives 2 courses of prednisone and 1 course of placebo.

Publication

N/A

Link

N/A

PI Name

John Rush

Degree

MD

Center

UT Southwestern Medical Center

Institution

N/A

Address

N/A

City or Town

Dallas

State or Province

TX

Zip or Postal Code

N/A

Country

USA

Email Address

john.rush@utsouthwestern.edu