Clinical trial NCT00329108: Ziprasidone And Olanzapine's Outcomes In Mania
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Mania
Bipolar Disorder, Manic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.
timeFrame: up to 10 weeks
measure: 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.
timeFrame: 6 months
measure: Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase.
timeFrame: 4, 6 and 10 weeks
measure: Time to Symptomatic Remission in the Double Blind Phase.
timeFrame: up to 10 weeks
measure: Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.
timeFrame: 6 weeks
measure: Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase.
timeFrame: 6 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Pfizer Investigational Site
city: Augsburg
country: Germany
facility: Pfizer Investigational Site
city: Freiburg
country: Germany
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: S. Arsenio
country: Italy
facility: Pfizer Investigational Site
state: Salerno
city: Bari
country: Italy
facility: Pfizer Investigational Site
city: Guardiagrele (CH)
country: Italy
facility: Pfizer Investigational Site
city: Lido Di Camaiore (LU)
country: Italy
facility: Pfizer Investigational Site
city: Partinico (Pa)
country: Italy
facility: Pfizer Investigational Site
city: Perugia
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Trieste
country: Italy
facility: Pfizer Investigational Site
city: Terrassa
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Alava
country: Spain
facility: Pfizer Investigational Site
state: Vitoria
city: Granada
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: