Ziprasidone And Olanzapine's Outcomes In Mania
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Mania; Bipolar Disorder, Manic
Intervention: ziprasidone hydrochloride (Drug); olanzapine (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase.
Secondary outcome: Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.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. Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-Blind Phase. Time to Symptomatic Remission in the Double Blind Phase. Percentage of Patients With Clinical Response After 6 Weeks of Double-Blind Treatment. Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Pfizer Investigational Site, Aachen 52074, Germany
Pfizer Investigational Site, Augsburg 86156, Germany
Pfizer Investigational Site, Freiburg 79104, Germany
Pfizer Investigational Site, Athens 124 62, Greece
Pfizer Investigational Site, Bari 70100, Italy
Pfizer Investigational Site, Guardiagrele (CH) 66016, Italy
Pfizer Investigational Site, Lido di Camaiore (LU) 55043, Italy
Pfizer Investigational Site, Partinico (Pa) 90047, Italy
Pfizer Investigational Site, Perugia 06127, Italy
Pfizer Investigational Site, Siena 53100, Italy
Pfizer Investigational Site, Torino 10126, Italy
Pfizer Investigational Site, Trieste 34126, Italy
Pfizer Investigational Site, Granada 18014, Spain
Pfizer Investigational Site, Malaga 29009, Spain
Pfizer Investigational Site, Ankara 06100, Turkey
Pfizer Investigational Site, Istanbul 34440, Turkey
Pfizer Investigational Site, Terrassa, Barcelona 08227, Spain
Pfizer Investigational Site, S. Arsenio, Salerno 84037, Italy
Pfizer Investigational Site, Alava, Vitoria 01004, Spain
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2006
Last updated: April 1, 2009
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