584
Participants
Start Date
December 31, 2005
Primary Completion Date
May 31, 2008
Study Completion Date
May 31, 2008
Placebo
Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID (twice a day) for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to placebo will be tapered off the open-label ziprasidone by 20 mg BID every 2 days (in a double-blinded manner) until they are completely off ziprasidone and are on matching placebo capsules for up to 24 weeks of double-blind treatment.
Ziprasidone Oral Capsule
Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to ziprasidone will continue to receive the same stable treatment regimen achieved during the open-label treatment, ie, either 40 mg BID, 60 mg BID or 80 mg BID for up to 24 weeks of double-blind treatment.
Pfizer Investigational Site, Taipei
Pfizer Investigational Site, Taipei
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Pfizer Investigational Site, Caracas
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Pfizer Investigational Site, Berlin
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Pfizer Investigational Site, Barcelona
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY