Loading clinical trials...

Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

NCT00257192•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

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

Detailed Description

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.

Eligibility

Age

13 - 17 years

Sex

ALL

Healthy Volunteers

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

Locations (92)

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

San Diego, California, United States

Pfizer Investigational Site

Stanford, California, United States

Pfizer Investigational Site

Aurora, Colorado, United States

Pfizer Investigational Site

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

Pfizer Investigational Site

Altamonte Springs, Florida, United States

Pfizer Investigational Site

Fort Lauderdale, Florida, United States

Pfizer Investigational Site

North Miami, Florida, United States

Key Dates

Start Date

April 1, 2006

Primary Completion Date

March 1, 2009

Completion Date

March 1, 2009

Last Updated

March 25, 2021

Enrollment

284

ACTUAL participants

Conditions

Schizophrenia

Interventions

placebo

DRUG

Ziprasidone oral capsules

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

View study

RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia

Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders

Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques

Brain Stimulation to the Hippocampus in Schizophrenia