Clinical trial NCT00650611: A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders
Official title: A 27-Week Open-Label Trial To Characterize The Safety And Tolerability Of Orally Administered Ziprasidone In Children And Adolescent Subjects With Bipolar I Disorder (Manic Or Mixed), Schizophrenia Or Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Bipolar Disorder
Schizoaffective Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 63
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders


Eligibility criteria: Inclusion Criteria:

* Children and teens with Bipolar I Disorder (manic or mixed), schizophrenia or schizoaffective disorder
* Willingness to discontinue all antipsychotic medications during the study period

Exclusion Criteria:

* Patients who are clinically stable on treatments that are well tolerated
* Substance-induced psychotic disorders

Primary outcomes:
measure: Adverse events at Baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27.
timeFrame: 27 weeks
measure: Electrocardiograms and vital signs at Screening, baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27.
timeFrame: 27 weeks
measure: Laboratory data at Screening and Weeks 3, 12, and 27.
timeFrame: 27 weeks
Secondary outcomes:
measure: Clinical Global Impressions-Improvement (CGI-I) scale scores on Day 4 and at Weeks 1, 2, and 3.
timeFrame: 3 weeks
measure: Mean change from baseline in Childrens' Global Assessment Scale (CGAS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.
timeFrame: 27 weeks
measure: Serum concentrations of ziprasidone and its major metabolites at Weeks 1, 3, 12, and 27.
timeFrame: 27 weeks
measure: Mean change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.
timeFrame: 27 weeks
measure: Mean change from baseline in Young Mania Rating Scale (YMRS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.
timeFrame: 27 weeks
measure: Mean change from baseline in Brief Psychiatric Rating Scale-Anchored (BPRS-A) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.
timeFrame: 27 weeks
measure: Mean change from baseline in movement disorder rating scale scores at Weeks 3, 12, and 27.
timeFrame: 27 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Altamonte Springs
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Libertyville
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Belmont
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Brighton
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Turnersville
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Kirkland
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Kirkland
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: