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| Adjunctive Oral Ziprasidone in Patients With Acute Mania Treated With Lithium or Divalproex, Part 2: Influence of Protocol-Specific Eligibility Criteria on Signal Detection |
| Gary S. Sachs, Douglas G. Vanderburg, Suzanne Edman, Onur N. Karayal, Sheela Kolluri, Mary Bachinsky, and Idil Cavus |
| Ziprasidone is currently FDA-approved as monotherapy for the treatment of patients with bipolar manic or mixed episodes. In a 3-week, randomized, placebo-controlled study, Gary Sachs and colleagues evaluated patients who received placebo with a mood stabilizer (lithium or divalproex) or adjunctive ziprasidone at a low or high dose with a mood stabilizer. Efficacy was measured as a change in the Young Mania Rating Scale score from baseline to week 3. |
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