Clinical trial NCT00265382: Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia
Official title: 26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Adolescent Subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-12-14
Enrollment: 221
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in adolescents (ages 13-17) with schizophrenia.

Detailed description: 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 criteria: Inclusion Criteria:

* Participation in double-blind treatment study A1281134, meeting specific criteria of duration and safety

Exclusion Criteria:

* Imminent risk of suicide or homicide, as judged by the site investigator
* Serious adverse event related to study medication in study A1281134
* Significant prolongation of QT interval in study A1281134

Primary outcomes:
measure: Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 26 weeks
Secondary outcomes:
measure: Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment
timeFrame: Baseline, Week 26, Early Termination (ET)
measure: Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score
timeFrame: Baseline, Weeks 2, 6, 18, 26, ET
measure: Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
timeFrame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
measure: Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
timeFrame: Baseline, Weeks 6 and 26, ET
measure: Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index
timeFrame: Baseline, Weeks 6 and 26, ET
measure: Change From Baseline in Simpson-Angus Rating Scale (SARS)
timeFrame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
measure: Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
timeFrame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
timeFrame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
measure: Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score
timeFrame: Baseline, Weeks 2, 6, 18, 26, ET
measure: Change From Baseline in Children's Global Assessment Scale (CGAS)
timeFrame: Baseline, Weeks 2, 6, 18, 26, ET
measure: Change From Baseline in Child Health Questionnaire (CHQ)
timeFrame: Baseline, Weeks 6 and 26, ET
measure: Number of Subjects Per Response on the School Placement Questionnaire: School Situation
timeFrame: Baseline, Weeks 6 and 26, ET
measure: Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
timeFrame: Baseline, Weeks 6 and 26, ET
measure: Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
timeFrame: Baseline, Weeks 6 and 26, ET
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orange City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Smyrna
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Tucker
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Des Plaines
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Schaumburg
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Clinton Township
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Bridgeton
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
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: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Bothell
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Bello
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Vijaywada
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Guj
city: Mangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Aurangabad
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Chennai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Kubang Kerian
country: Malaysia
facility: Pfizer Investigational Site
state: Kelantan
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lipetsk Region
country: Russian Federation
facility: Pfizer Investigational Site
state: Russia
city: Kazan
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Pfizer Investigational Site
city: Saratov
country: Russian Federation
facility: Pfizer Investigational Site
city: Saratov
country: Russian Federation
facility: Pfizer Investigational Site
city: Tver
country: Russian Federation
facility: Pfizer Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Simferopol
country: Ukraine
facility: Pfizer Investigational Site
state: Crimea
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Donetsk
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Lugansk
country: Ukraine
facility: Pfizer Investigational Site
city: Lviv
country: Ukraine
facility: Pfizer Investigational Site
city: Odess
country: Ukraine
facility: Pfizer Investigational Site
city: Poltava
country: Ukraine
facility: Pfizer Investigational Site
city: Vinnytsya
country: Ukraine
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.