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Ziprasidone And Olanzapine's Outcomes In Mania

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NCT00329108

Last updated on March 22, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aachen, , 52074 Germany
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Mania, Manic Bipolar Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00329108
Pfizer
Terminated
Ziprasidone And Olanzapine's Outcomes In Mania

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Ziprasidone And Olanzapine's Outcomes In Mania
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Mania
  • Bipolar Disorder, Manic
  • 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.
    Other Name: Geodon, Zeldox
  • 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.
  • Experimental: A
    Intervention: Drug: ziprasidone hydrochloride
  • Active Comparator: B
    Intervention: Drug: olanzapine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
29
January 2008
July 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Greece,   Italy,   Spain,   Turkey
France
 
NCT00329108
A1281147
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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