A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

December 31, 2003

Study Completion Date

March 31, 2005

Conditions
SchizophreniaBipolar DisorderSchizoaffective Disorder
Interventions
DRUG

Ziprasidone

"Period 1: Initial dose of oral ziprasidone suspension 20 mg twice daily, which was titrated up in 20 mg twice daily increments to a maximum dose of 80 mg twice daily by Day 10.~Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1."

DRUG

Ziprasidone

"Period 1: Initial dose of oral ziprasidone suspension 10 mg twice daily, which was titrated up in 10 mg twice daily increments to a maximum dose of 40 mg twice daily by Day 10.~Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1."

Trial Locations (17)

32701

Pfizer Investigational Site, Altamonte Springs

40509

Pfizer Investigational Site, Lexington

44106

Pfizer Investigational Site, Cleveland

45224

Pfizer Investigational Site, Cincinnati

45229

Pfizer Investigational Site, Cincinnati

60048

Pfizer Investigational Site, Libertyville

89103

Pfizer Investigational Site, Las Vegas

89117

Pfizer Investigational Site, Las Vegas

89128

Pfizer Investigational Site, Las Vegas

92111

Pfizer Investigational Site, San Diego

98033

Pfizer Investigational Site, Kirkland

98034

Pfizer Investigational Site, Kirkland

02478

Pfizer Investigational Site, Belmont

02135

Pfizer Investigational Site, Brighton

08012

Pfizer Investigational Site, Turnersville

45267-0559

Pfizer Investigational Site, Cincinnati

19104-3309

Pfizer Investigational Site, Philadelphia

All Listed Sponsors
lead

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

INDUSTRY

NCT00650611 - A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders | Biotech Hunter | Biotech Hunter