The purpose of this study is to compare the efficacy and tolerability of ziprasidone versus olanzapine in the treatment of acute mania. An open label extension will further evaluate the efficacy, safety, and tolerability of ziprasidone compared with olanzapine. Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on July 30, 2007. Subjects that were enrolled at the time completed the study as per protocol. There were no safety concerns involved in the decision to stop enrollment. The Last Subject Last Visit was January 10, 2008.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
29
Ziprasidone will be initiated at 80 mg/day on Day 1 and titrated to 120 mg/day from Day 3. From Day 7 the dosage may be adjusted on the basis of clinical status between 120 and 160 mg/day.
Olanzapine will be started at 15 mg/day on Day 1 until Day 7. The dosage will then be adjusted on the basis of clinical status between 15 and 20 mg/day.
Pfizer Investigational Site
Aachen, Germany
Pfizer Investigational Site
Augsburg, Germany
Pfizer Investigational Site
Freiburg im Breisgau, Germany
Pfizer Investigational Site
Athens, Greece
Pfizer Investigational Site
S. Arsenio, Salerno, Italy
Pfizer Investigational Site
Bari, Italy
Pfizer Investigational Site
Guardiagrele (CH), Italy
Pfizer Investigational Site
Lido Di Camaiore (LU), Italy
Pfizer Investigational Site
Partinico (Pa), Italy
Pfizer Investigational Site
Perugia, Italy
...and 9 more locations
Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase.
YMRS is 11-item instrument with scales between 0 to 4 for 7 items and scales between 0 and 8 for 4 items. 0 is normal and either 4 or 8 is the highest level of abnormal, depending on the item.
Time frame: 4 weeks
Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.
Time frame: up to 10 weeks
Change From Baseline in Global Assessment of Functioning Scale Scores, Treatment Satisfaction Questionnaire for Medication, Quality of Life Enjoyment and Satisfaction Questionnaire in the Double Blind Phase.
Time frame: 6 months
Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase.
Time frame: 4, 6 and 10 weeks
Time to Symptomatic Remission in the Double Blind Phase.
Time frame: up to 10 weeks
Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.
Time frame: 6 weeks
Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase.
Time frame: 6 months
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