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Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria
for schizophrenia: Current symptoms were to be present for at least 7 days before
screening.

- At the Screening and Baseline visits, subjects must have had a Brief Psychiatric
Rating Scale - Anchored score ≥35 and a score of ≥4 on at least 1 of the following
items: unusual thought content (i.e., delusions), hallucinations, suspiciousness, or
conceptual disorganization.

- Age 13 - 17 years

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

- Imminent risk of suicide or homicide, as judged by the site investigator

- Any history of serious or unstable medical illness, including risk for QT prolongation

NCT00257192
Pfizer
Terminated
Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

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Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia
Six Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of adolescents (ages 13-17) with schizophrenia
Termination Reason: On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: placebo
    Placebo matching the oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.
  • Drug: Ziprasidone oral capsules
    Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg BID to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.
    Other Name: Geodon, Zeldox
  • Placebo Comparator: 2.0
    Intervention: Drug: placebo
  • Active Comparator: 1.0
    Intervention: Drug: Ziprasidone oral capsules
Findling RL, Cavu? I, Pappadopulos E, Vanderburg DG, Schwartz JH, Gundapaneni BK, DelBello MP. Ziprasidone in adolescents with schizophrenia: results from a placebo-controlled efficacy and long-term open-extension study. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):531-44. doi: 10.1089/cap.2012.0068. Epub 2013 Oct 10.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
284
March 2009
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia: Current symptoms were to be present for at least 7 days before screening.
  • At the Screening and Baseline visits, subjects must have had a Brief Psychiatric Rating Scale - Anchored score ?35 and a score of ?4 on at least 1 of the following items: unusual thought content (i.e., delusions), hallucinations, suspiciousness, or conceptual disorganization.
  • Age 13 - 17 years

Exclusion Criteria:

  • Imminent risk of suicide or homicide, as judged by the site investigator
  • Any history of serious or unstable medical illness, including risk for QT prolongation
Sexes Eligible for Study: All
13 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Colombia,   Costa Rica,   India,   Malaysia,   Peru,   Russian Federation,   Singapore,   Ukraine,   United States
Canada,   Germany,   Mexico,   Sweden
 
NCT00257192
A1281134
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2011

ICMJE     Data element required by the

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

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