Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia

NCT00265382 | Terminated Phase 3 Results DMC

• 1 other identifier: A1281135
• Study Type: interventional
• Target: 221
• Locations: 8 countries
• Sites: 66

Brief Summary

The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in adolescents (ages 13-17) with schizophrenia.

Conditions

Schizophrenia

Keywords

Adolescent Subjects

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.

  26 weeks

Secondary Outcomes (14)

• Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment

  Baseline, Week 26, Early Termination (ET)

• Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score

  Baseline, Weeks 2, 6, 18, 26, ET

• Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score

  Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET

• Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales

  Baseline, Weeks 6 and 26, ET

• Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index

  Baseline, Weeks 6 and 26, ET

Study Arms (1)

Open

OTHER

Drug: Ziprasidone oral capsules

Interventions

Ziprasidone oral capsules DRUG

Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid.

Also known as: Geodon, Zeldox

Open

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participation in double-blind treatment study A1281134, meeting specific criteria of duration and safety

You may not qualify if:

• Imminent risk of suicide or homicide, as judged by the site investigator
• Serious adverse event related to study medication in study A1281134
• Significant prolongation of QT interval in study A1281134

Sponsors & Collaborators

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

Study Sites (68)

Pfizer Investigational Site

Birmingham, Alabama, 35205, United States

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Birmingham, Alabama, 35294-4400, United States

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Birmingham, Alabama, 35294, United States

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San Diego, California, 92123-2717, United States

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Denver, Colorado, 80218, United States

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Washington D.C., District of Columbia, 20010, United States

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Altamonte Springs, Florida, 32701, United States

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Orange City, Florida, 32763, United States

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Smyrna, Georgia, 30080, United States

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Tucker, Georgia, 30084, United States

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Des Plaines, Illinois, 60016, United States

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Oakbrook Terrace, Illinois, 60181, United States

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Schaumburg, Illinois, 60194, United States

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Clinton Township, Michigan, 48038, United States

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Bridgeton, Missouri, 63044-2588, United States

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St Louis, Missouri, 63141, United States

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Buffalo, New York, 14215, United States

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Rochester, New York, 14618, United States

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Cincinnati, Ohio, 45224, United States

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Cincinnati, Ohio, 45229, United States

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Cincinnati, Ohio, 45267-0559, United States

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Cleveland, Ohio, 44106, United States

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Oklahoma City, Oklahoma, 73101, United States

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Oklahoma City, Oklahoma, 73116, United States

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Bothell, Washington, 98011, United States

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Spokane, Washington, 99204, United States

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Bello, Antioquia, Colombia

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Bogota, Cundinamarca, Colombia

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San José, Costa Rica

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Vijaywada, Andhra Pradesh, 520 002, India

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Ahmedabad, Guj, 380015, India

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Mangalore, Karnataka, 575001, India

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Aurangabad, Maharashtra, 431 005, India

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Mumbai, Maharashtra, 400 058, India

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Pune, Maharashtra, 411 001, India

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Pune, Maharashtra, 411 046, India

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Ludhiana, Punjab, 141001, India

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Chennai, Tamil Nadu, 600 003, India

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Kubang Kerian, Kelantan, 16150, Malaysia

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Kuala Lumpur, 50586, Malaysia

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Kuala Lumpur, 50603, Malaysia

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Kuala Lumpur, 55100, Malaysia

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Lima, L13, Peru

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Lima, L41, Peru

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Lipetsk Region, Russia, 399313, Russia

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Kazan', 420012, Russia

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Moscow, 107076, Russia

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Moscow, 115522, Russia

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Moscow, 117152, Russia

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Moscow, 127473, Russia

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Nizhny Novgorod, 603155, Russia

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Saratov, 410012, Russia

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Saratov, 410060, Russia

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Tver', 170005, Russia

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Yaroslavl, 150003, Russia

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Singapore, 229899, Singapore

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Singapore, 539747, Singapore

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Simferopol, Autonomous Republic of Crimea, 95006, Ukraine

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Dnipropetrovsk, 49005, Ukraine

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Dnipropetrovsk, 49115, Ukraine

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Donetsk, 83037, Ukraine

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Kharkiv, 61068, Ukraine

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Kyiv, 04655, Ukraine

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Luhansk, 91045, Ukraine

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Lviv, 79021, Ukraine

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Odesa, 65006, Ukraine

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Poltava, 36006, Ukraine

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Pfizer Investigational Site

Vinnytsia, 21005, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 24111983 DERIVED

Related Links

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

MeSH Terms

Conditions

Schizophrenia

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

The AE tables were amended to incorporate previously unreported AEs that were found during an independent audit and verified by the investigators.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 14, 2005
• Study Start: June 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 3, 2021
• Results First Posted: May 19, 2010

Record last verified: 2021-03

Locations

PE (2); UA (11); RU (11); CO (1); US (26); SG (2); MY (4); IN (9)