Ziprasidone And Olanzapine's Outcomes In Mania

Condition(s) targeted: Bipolar Disorder

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

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.

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

Primary outcome: The mean reduction after 4 weeks of treatment in the Young Mania Rating Scale 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.

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.

Pfizer Investigational Site, Freiburg 79104, Germany

Pfizer Investigational Site, Aachen 52074, Germany

Pfizer Investigational Site, Augsburg 86156, Germany

Pfizer Investigational Site, Athens 124 62, Greece

Pfizer Investigational Site, Trieste 34126, Italy

Pfizer Investigational Site, Bari 70100, Italy

Pfizer Investigational Site, Torino 10126, Italy

Pfizer Investigational Site, Guardiagrele (CH) 66016, Italy

Pfizer Investigational Site, Perugia 06127, Italy

Pfizer Investigational Site, Partinico (Pa) 90047, Italy

Pfizer Investigational Site, Siena 53100, Italy

Pfizer Investigational Site, Lido di Camaiore (LU) 55043, Italy

Pfizer Investigational Site, GRANADA 18014, Spain

Pfizer Investigational Site, MALAGA 29009, Spain

Pfizer Investigational Site, Istanbul 34440, Turkey

Pfizer Investigational Site, Ankara 06100, Turkey

Pfizer Investigational Site, TERRASSA, BARCELONA 08227, Spain

Pfizer Investigational Site, S. Arsenio, Salerno 84037, Italy

Pfizer Investigational Site, ALAVA, VITORIA 01004, Spain

To obtain contact information for a study center near you, click here.

Starting date: November 2006
Ending date: January 2008
Last updated: June 19, 2008