Official Title: “A Multicenter, Randomized, Double-Blind, Parallel Group Study, Comparing The Efficacy And Tolerability Of Ziprasidone (Zeldox, Geodon) vs. Olanzapine (Zyprexa) In The Treatment And Maintenance Of Response In Patients With Acute Mania”

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

Study Design: Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Safety Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Drug: ziprasidone hydrochloride
  • 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.
• Drug: olanzapine
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B

Primary Measures

• The mean reduction after 4 weeks of treatment in the Young Mania Rating Scale score during the double blind phase.
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• Time to symptomatic remission in the double blind phase.
  • Time Frame: up to 10 weeks
    Safety Issue?: No
• Percentage of patients with clinical response after 6 weeks of double-blind treatment.
  • Time Frame: 6 weeks
    Safety Issue?: No
• Percentage of patients with symptomatic relapse of mania and/or symptomatic relapse of depression during the open label phase.
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

• Have a primary diagnosis of Bipolar I Disorder, current episode manic (DSM-IV 296.4x) or mixed (DSM-IV296.6x) as determined by a structured clinical interview (Mini
• International Neuropsychiatric Interview (MINI)) at screening.
• A minimum score of 20 on the YMRS (Youngs Mania Rating Scale).

Exclusion Criteria:

• Have a diagnosis of learning disability or organic brain syndrome.
• Have a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00329108

Study ID Number: A1281147

ClinicalTrials.gov Identifier: NCT00329108

Health Authority: Italy: Ministry of Health

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