Trials Sponsors Conditions Drugs Pricing

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
+9 more secondary outcomes

Study Arms (1)

Open

OTHER

Drug: Ziprasidone oral capsules

Interventions

Ziprasidone oral capsulesDrug

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

Age13 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (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:

Sponsors & Collaborators

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

Study Sites (68)

Pfizer Investigational Site

Birmingham, Alabama, 35205, United States

Pfizer Investigational Site

Birmingham, Alabama, 35294-4400, United States

Pfizer Investigational Site

Birmingham, Alabama, 35294, United States

Pfizer Investigational Site

San Diego, California, 92123-2717, United States

Pfizer Investigational Site

Denver, Colorado, 80218, United States

Pfizer Investigational Site

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

Pfizer Investigational Site

Altamonte Springs, Florida, 32701, United States

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: 24111983DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental 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.

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR

Publication Agreements

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

Enrollment

221 participants (actual enrollment reported by the registry).

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 2006

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Study Arms (1)

Open

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (68)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations

Study Stopped

Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Study Arms (1)

Open

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (68)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations