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Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

NCT ID: NCT00257192

Last Updated: 2021-03-25

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2.0

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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.

1.0

Group Type ACTIVE_COMPARATOR

Ziprasidone oral capsules

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Geodon, Zeldox

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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San Diego, California, United States

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Stanford, California, United States

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Aurora, Colorado, United States

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Washington D.C., District of Columbia, United States

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Altamonte Springs, Florida, United States

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Fort Lauderdale, Florida, United States

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North Miami, Florida, United States

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Orange City, Florida, United States

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Tampa, Florida, United States

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Tavares, Florida, United States

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Smyrna, Georgia, United States

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Tucker, Georgia, United States

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Honolulu, Hawaii, United States

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Des Plaines, Illinois, United States

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Oakbrook Terrace, Illinois, United States

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Schaumburg, Illinois, United States

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Pikesville, Maryland, United States

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Towson, Maryland, United States

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Towson, Maryland, United States

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Clinton Township, Michigan, United States

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Meridian, Mississippi, United States

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Bridgeton, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Buffalo, New York, United States

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Buffalo, New York, United States

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Rochester, New York, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Arlington, Texas, United States

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DeSoto, Texas, United States

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Plano, Texas, United States

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Bothell, Washington, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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West Allis, Wisconsin, United States

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Medellín, Antioquia, Colombia

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Bogota, Cundinamarca, Colombia

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San José, , Costa Rica

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Vijaywada, Andhra Pradesh, India

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Visakhapatnam, Andra Pradesh/India, India

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Ahmedabad, Guj, India

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Mangalore, Karnataka, India

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Aurangabad, Maharashtra, India

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Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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Pune, Maharashtra, India

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Ludhiana, Punjab, India

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Chennai, Tamil Nadu, India

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Kubang Kerian, Kelantan, Malaysia

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Kuala Lumpur, , Malaysia

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Kuala Lumpur, , Malaysia

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Kuala Lumpur, , Malaysia

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Lima, , Peru

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Lima, , Peru

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Kazan', , Russia

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Khotkovo, Moscow Region, , Russia

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Lipetsk Region, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Saratov, , Russia

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Tver', , Russia

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Yaroslavl, , Russia

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Singapore, , Singapore

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Singapore, , Singapore

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Simferopol, Autonomous Republic of Crimea, Ukraine

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Dnipropetrovsk, , Ukraine

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Luhansk, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Poltava, , Ukraine

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Vinnytsia, , Ukraine

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Countries

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United States Colombia Costa Rica India Malaysia Peru Russia Singapore Ukraine

References

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Findling RL, Cavus 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.

Reference Type DERIVED
PMID: 24111983 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281134&StudyName=Safety%20and%20efficacy%20of%20ziprasidone%20in%20adolescents%20with%20schizophrenia

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

Other Identifiers

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A1281134

Identifier Type: -

Identifier Source: org_study_id

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