Clinical trial NCT02075047: Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
Official title: A PHASE 3, MULTICENTER, FOUR-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EFFICACY AND SAFETY TRIAL OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (CURRENT OR MOST RECENT EPISODE MANIC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Bipolar I Disorder (current or most recent episode manic). Children and adolescents aged 10 to 17 years.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-03-03
Enrollment: 171
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 determine if ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).


Eligibility criteria: Inclusion Criteria:

* DSM V criteria for Bipolar I disorder (manic or mixed); age 10 - 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.

Primary outcomes:
measure: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 1, 2, and 3
timeFrame: Baseline, Week 1, 2, 3
measure: Clinical Global Impression of Improvement (CGI-I) Scores at Weeks 1, 2, 3, and 4
timeFrame: Baseline, Week 1, 2, 3, 4
Other outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Screening (2 Weeks prior to Day 1) up to maximum of 5 Weeks after administration of the final dose of study medication (maximum up to 11 weeks)
measure: Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Screening (2 Weeks prior to Day 1), Baseline (Day 1), Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9)
measure: Number of Participants Who Took at Least 1 Concomitant Medication and Concomitant Non-Drug Treatments/Procedures
timeFrame: Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks)
measure: Number of Participants With Physical Examination Abnormalities
timeFrame: Screening (2 Weeks prior to Day 1) up to Week 4
measure: Change From Baseline in Blood Pressure at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit
timeFrame: Baseline, Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9)
measure: Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit
timeFrame: Baseline, Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9)
measure: Change From Baseline in Height and Waist Circumference at Week 4 and Early Termination Visit
timeFrame: Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4)
measure: Change From Baseline in Body Weight at Week 4 and Early Termination Visit
timeFrame: Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4)
measure: Change From Baseline in Body Mass Index (BMI) at Week 4 and Early Termination Visit
timeFrame: Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4)
measure: Change From Baseline in Body Mass Index (BMI) Z-score at Week 4 and Early Termination Visit
timeFrame: Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4)
measure: Number of Participants With Pre-defined Categories of Electrocardiogram (ECG) Findings
timeFrame: Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks)
measure: Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Weeks 1, 2, 3, and 4 and Early Termination Visit
timeFrame: Baseline, Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4)
measure: Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Weeks 1, 2, 3, and 4
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Change From Baseline in Barnes Akathisia Rating Scale (BAS): Global Clinical Assessment of Akathisia Subscale Score at Weeks 1, 2, 3, and 4
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) - Movement Cluster Score at Weeks 1, 2, 3, and 4
timeFrame: Baseline, Week 1, 2, 3, 4
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research, Inc.
state: Alabama
city: Little Rock
country: United States
facility: Woodland International Research Group Inc.
state: Arkansas
city: Little Rock
country: United States
facility: Woodland International Research Group, LLC
state: Arkansas
city: Anaheim
country: United States
facility: California Pharmaceutical Research Institute
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Panorama City
country: United States
facility: Asclepes Research Centers
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center MIND Institute
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Incorporated
state: California
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
city: Boca Raton
country: United States
facility: Da Vinci Research Institute Inc
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: APG Research LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Fayetteville
country: United States
facility: Inova Clinical Trials and Research Centre
state: Georgia
city: Smyrna
country: United States
facility: Attalla Consultants, LLC dba Institute for Behavioral Medicine
state: Georgia
city: Vernon Hills
country: United States
facility: Sleep and Behavior Medicine Institute
state: Illinois
city: Baltimore
country: United States
facility: Hugo W. Moser Research Institute at Kennedy Krieger Institute Clinical Trials Unit
state: Maryland
city: Baltimore
country: United States
facility: Kennedy Krieger Institute Inpatient Clinic
state: Maryland
city: Baltimore
country: United States
facility: Kennedy Krieger Institute Outpatient Clinic
state: Maryland
city: Baltimore
country: United States
facility: Psychiatric Mental Health Program at Kennedy Krieger Institute Clinical Trials Unit
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital Pediatric Clinical Research Unit
state: Maryland
city: Baltimore
country: United States
facility: Charlotte R. Bloomberg Children's Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital Investigational Drug Services
state: Maryland
city: Marlton
country: United States
facility: Clinical Research Integrity(CRI) Lifetree, LLC
state: New Jersey
city: Buffalo
country: United States
facility: Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
state: New York
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital Northwell Health
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals, LLC
state: Oklahoma
city: Houston
country: United States
facility: UT Health Science Center at Houston (UTHSC-H)
state: Texas
city: Plano
country: United States
facility: AIM Trials
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry Of The Woodlands
state: Texas
city: Charlottesville
country: United States
facility: Fontaine Medical Laboratories
state: Virginia
city: Charlottesville
country: United States
facility: Northridge Medical Plaza
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia Center for Psychopharmacology Research in Youth
state: Virginia
city: Charlottesville
country: United States
facility: UVA Child & Family Psychiatry Clinic
state: Virginia
city: Petersburg
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Roanoke
country: United States
facility: Carilion Medical Center
state: Virginia
city: Everett
country: United States
facility: Eastside Therapeutic Resource dba Core Clinical Research
state: Washington
city: Dnipro
country: Ukraine
facility: Communal Non profit Enterprise "City Children Clinical Hospital #5 of Dnipro Regional Council"
city: Dnipro
country: Ukraine
facility: Communal Nonprofit Enterprise "City Children Clinical Hospital #5 of Dnipro Regional Council
city: Odesa
country: Ukraine
facility: Communal Nonprofit Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa
city: Vinnytsya
country: Ukraine
facility: Municipal Institution "Vinnytsya Regional Psychoneurologycal Hospital Named After O.I. Yushenko"
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Findling RL, Atkinson S, Bachinsky M, Raiter Y, Abreu P, Ianos C, Chappell P. Efficacy, Safety, and Tolerability of Flexibly Dosed Ziprasidone in Children and Adolescents with Mania in Bipolar I Disorder: A Randomized Placebo-Controlled Replication Study. J Child Adolesc Psychopharmacol. 2022 Apr;32(3):143-152. doi: 10.1089/cap.2021.0121. Epub 2022 Apr 7.