Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder

NCT02075047 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: A1281198
• Study Type: interventional
• Target: 171
• Locations: 2 countries
• Sites: 50

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).

Conditions

Bipolar Disorder

Keywords

Bipolar I Disorder (current or most recent episode manic). Children and adolescents aged 10 to 17 years.

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4

  YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania.

  Baseline, Week 4

Secondary Outcomes (3)

• Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4

  Baseline, Week 1, 2, 3, 4

• Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 1, 2, and 3

  Baseline, Week 1, 2, 3

• Clinical Global Impression of Improvement (CGI-I) Scores at Weeks 1, 2, 3, and 4

  Baseline, Week 1, 2, 3, 4

Other Outcomes (16)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  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)

• Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS)

  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)

• Number of Participants Who Took at Least 1 Concomitant Medication and Concomitant Non-Drug Treatments/Procedures

  Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks)

Study Arms (2)

1

PLACEBO COMPARATOR

Drug: placebo oral capsules

ziprasidone

EXPERIMENTAL

Drug: ziprasidone oral capsules

Interventions

placebo oral capsules DRUG

Placebo matching the oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects \<45 kg having a target dose range of 60-80 mg/day and subjects \>/= 45 kg having a target dose range of 120-180 mg/day.

1

ziprasidone oral capsules DRUG

Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects \<45 kg having a target dose range of 60-80 mg/day and subjects \>/= 45 kg having a target dose range of 120-180 mg/day.

ziprasidone

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• DSM V criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (50)

Harmonex Neuroscience Research, Inc.

Dothan, Alabama, 36303, United States

Location

Woodland International Research Group Inc.

Little Rock, Arkansas, 72211, United States

Location

Woodland International Research Group, LLC

Little Rock, Arkansas, 72211, United States

Location

California Pharmaceutical Research Institute

Anaheim, California, 92804, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

Asclepes Research Centers

Panorama City, California, 91402, United States

Location

University of California Davis Medical Center MIND Institute

Sacramento, California, 95817, United States

Location

Elite Clinical Trials, Incorporated

Wildomar, California, 92595, United States

Location

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Da Vinci Research Institute Inc

Boca Raton, Florida, 33487, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

APG Research LLC

Orlando, Florida, 32803, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Inova Clinical Trials and Research Centre

Fayetteville, Georgia, 30214, United States

Location

Attalla Consultants, LLC dba Institute for Behavioral Medicine

Smyrna, Georgia, 30082-2629, United States

Location

Sleep and Behavior Medicine Institute

Vernon Hills, Illinois, 60061, United States

Location

Hugo W. Moser Research Institute at Kennedy Krieger Institute Clinical Trials Unit

Baltimore, Maryland, 21205, United States

Location

Kennedy Krieger Institute Inpatient Clinic

Baltimore, Maryland, 21205, United States

Location

Kennedy Krieger Institute Outpatient Clinic

Baltimore, Maryland, 21205, United States

Location

Psychiatric Mental Health Program at Kennedy Krieger Institute Clinical Trials Unit

Baltimore, Maryland, 21205, United States

Location

Johns Hopkins Hospital Pediatric Clinical Research Unit

Baltimore, Maryland, 21231, United States

Location

Charlotte R. Bloomberg Children's Center

Baltimore, Maryland, 21287, United States

Location

Johns Hopkins Hospital Investigational Drug Services

Baltimore, Maryland, 21287, United States

Location

Clinical Research Integrity(CRI) Lifetree, LLC

Marlton, New Jersey, 08053, United States

Location

Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate

Buffalo, New York, 14215, United States

Location

The Zucker Hillside Hospital Northwell Health

Glen Oaks, New York, 11004, United States

Location

Manhattan Behavioral Medicine

New York, New York, 10022, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

Location

Paradigm Research Professionals, LLC

Oklahoma City, Oklahoma, 73118, United States

Location

UT Health Science Center at Houston (UTHSC-H)

Houston, Texas, 77054, United States

Location

AIM Trials

Plano, Texas, 75093, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

Family Psychiatry Of The Woodlands

The Woodlands, Texas, 77381, United States

Location

Fontaine Medical Laboratories

Charlottesville, Virginia, 22903, United States

Location

Northridge Medical Plaza

Charlottesville, Virginia, 22903, United States

Location

University of Virginia Center for Psychopharmacology Research in Youth

Charlottesville, Virginia, 22903, United States

Location

UVA Child & Family Psychiatry Clinic

Charlottesville, Virginia, 22903, United States

Location

Clinical Research Partners, LLC

Petersburg, Virginia, 23805, United States

Location

Carilion Medical Center

Roanoke, Virginia, 24014, United States

Location

Eastside Therapeutic Resource dba Core Clinical Research

Everett, Washington, 98201, United States

Location

Communal Non profit Enterprise "City Children Clinical Hospital #5 of Dnipro Regional Council"

Dnipro, 49027, Ukraine

Location

Communal Nonprofit Enterprise "City Children Clinical Hospital #5 of Dnipro Regional Council

Dnipro, 49101, Ukraine

Location

Communal Nonprofit Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa

Odesa, 65006, Ukraine

Location

Municipal Institution "Vinnytsya Regional Psychoneurologycal Hospital Named After O.I. Yushenko"

Vinnytsia, 21018, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 35394365 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 3, 2014
• Study Start: May 23, 2014
• Primary Completion: April 11, 2020
• Study Completion: May 18, 2020
• Last Updated: June 16, 2021
• Results First Posted: April 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

US (46); UA (4)