Ziprasidone And Olanzapine's Outcomes In Mania

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NCT00329108

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Study Location
Pfizer Investigational Site
Aachen, , 52074, Germany
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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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.

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Acute Mania, Manic Bipolar DisorderZiprasidone And Olanzapine's Outcomes In Mania
NCT00329108
  1. Aachen,
  2. Augsburg,
  3. Freiburg,
  4. Athens,
  5. S. Arsenio, Salerno
  6. Bari,
  7. Guardiagrele (CH),
  8. Lido di Camaiore (LU),
  9. Partinico (Pa),
  10. Perugia,
  11. Siena,
  12. Torino,
  13. Trieste,
  14. Terrassa, Barcelona
  15. Alava, Vitoria
  16. Granada,
  17. Malaga,
  18. Ankara,
  19. Istanbul,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Ziprasidone And Olanzapine's Outcomes In Mania
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Mania
  • Bipolar Disorder, Manic
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: ziprasidone hydrochloride
  • Active Comparator: B
    Intervention: Drug: olanzapine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 12, 2009)		29
Original Enrollment  ICMJE
 (submitted: May 22, 2006)		352
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Greece,   Italy,   Spain,   Turkey
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT00329108
Other Study ID Numbers  ICMJE A1281147
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP