Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

NCT00257192 | Terminated Phase 3 Results DMC

• 1 other identifier: A1281134
• Study Type: interventional
• Target: 284
• Locations: 8 countries
• Sites: 91

Brief Summary

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

Conditions

Schizophrenia

Keywords

Adolescent Subjects With Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6

  BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.

  Baseline, Week 6

Secondary Outcomes (18)

• Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6

  Baseline, Week 6

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6

  Baseline, Week 6

• Change From Baseline in PANSS: Positive and Negative Subscales at Week 6

  Baseline, Week 6

• Clinical Global Impression of Improvement (CGI-I) Score at Week 6

  Baseline, Week 6

• Change From Baseline in Children's Global Assessment Scale (CGAS)

  Baseline, Week 2, Week 4, Week 6, Early termination (ET)

Study Arms (2)

2.0

PLACEBO COMPARATOR

Drug: placebo

1.0

ACTIVE COMPARATOR

Drug: Ziprasidone oral capsules

Interventions

placebo 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.

2.0

Ziprasidone oral capsules 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.

Also known as: Geodon, Zeldox

1.0

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (92)

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, United States

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Stanford, California, 94305, United States

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Aurora, Colorado, 80045, 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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Fort Lauderdale, Florida, 33301, United States

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North Miami, Florida, 33161, United States

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Orange City, Florida, 32763, United States

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Tampa, Florida, 33613, United States

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Tavares, Florida, 32778, United States

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Smyrna, Georgia, 30080, United States

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Tucker, Georgia, 30084, United States

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Honolulu, Hawaii, 96813, 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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Pikesville, Maryland, 21208, United States

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Towson, Maryland, 21204, United States

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Towson, Maryland, 21286, United States

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Clinton Township, Michigan, 48038, United States

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Meridian, Mississippi, 39301, 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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Lincoln, Nebraska, 68510, United States

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Omaha, Nebraska, 68131, United States

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Buffalo, New York, 14209, 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, 45219, United States

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Cincinnati, Ohio, 45224, United States

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Cincinnati, Ohio, 45229, 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, 73107, United States

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Oklahoma City, Oklahoma, 73116, United States

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Arlington, Texas, 76011, United States

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DeSoto, Texas, 75115, United States

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Plano, Texas, 75093, United States

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Bothell, Washington, 98011, United States

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Spokane, Washington, 99204, United States

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Spokane, Washington, 99216, United States

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Milwaukee, Wisconsin, 53226, United States

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West Allis, Wisconsin, 53227, 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, 520 002, India

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Visakhapatnam, Andra Pradesh/India, 530 017, 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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Kazan', 420012, Russia

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Khotkovo, Moscow Region, 142601, Russia

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Lipetsk Region, 399313, 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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Moscow, 143300, Russia

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Nizhny Novgorod, 603155, Russia

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Saint Petersburg, 192019, 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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Vinnytsia, 21005, Ukraine

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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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2005
• First Posted: November 22, 2005
• Study Start: April 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 25, 2021
• Results First Posted: April 13, 2010

Record last verified: 2021-03

Locations

MY (4); RU (14); CO (2); UA (11); IN (10); PE (2); US (46); SG (2)