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Bipolar DisorderPhase 3NCT02075047

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

A Phase 3 study testing ziprasidone oral capsules in people with Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 50 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Bipolar Disorder
What is being tested?
ziprasidone oral capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
171 participants
Where
50 sitesin 2 countries
Study dates
23 May 2014to 18 May 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

50 sites in 2 countries.

50 sites in 2 countries

United States46 sites

  • California Pharmaceutical Research Institute

    Anaheim, California, 92804

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

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

    Baltimore, Maryland, 21205

  • Kennedy Krieger Institute Inpatient Clinic

    Baltimore, Maryland, 21205

  • Kennedy Krieger Institute Outpatient Clinic

    Baltimore, Maryland, 21205

  • Psychiatric Mental Health Program at Kennedy Krieger Institute Clinical Trials Unit

    Baltimore, Maryland, 21205

  • Johns Hopkins Hospital Pediatric Clinical Research Unit

    Baltimore, Maryland, 21231

  • Charlotte R. Bloomberg Children's Center

    Baltimore, Maryland, 21287

  • Johns Hopkins Hospital Investigational Drug Services

    Baltimore, Maryland, 21287

  • Da Vinci Research Institute Inc

    Boca Raton, Florida, 33487

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

    Buffalo, New York, 14215

  • Fontaine Medical Laboratories

    Charlottesville, Virginia, 22903

  • Northridge Medical Plaza

    Charlottesville, Virginia, 22903

  • University of Virginia Center for Psychopharmacology Research in Youth

    Charlottesville, Virginia, 22903

  • UVA Child & Family Psychiatry Clinic

    Charlottesville, Virginia, 22903

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The Ohio State University

    Columbus, Ohio, 43210

  • Harmonex Neuroscience Research, Inc.

    Dothan, Alabama, 36303

  • Eastside Therapeutic Resource dba Core Clinical Research

    Everett, Washington, 98201

  • Inova Clinical Trials and Research Centre

    Fayetteville, Georgia, 30214

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • The Zucker Hillside Hospital Northwell Health

    Glen Oaks, New York, 11004

  • UT Health Science Center at Houston (UTHSC-H)

    Houston, Texas, 77054

  • Woodland International Research Group Inc.

    Little Rock, Arkansas, 72211

  • Woodland International Research Group, LLC

    Little Rock, Arkansas, 72211

  • Clinical Research Integrity(CRI) Lifetree, LLC

    Marlton, New Jersey, 08053

  • Manhattan Behavioral Medicine

    New York, New York, 10022

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

  • Paradigm Research Professionals, LLC

    Oklahoma City, Oklahoma, 73118

  • NRC Research Institute

    Orange, California, 92868

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763

  • APG Research LLC

    Orlando, Florida, 32803

  • Asclepes Research Centers

    Panorama City, California, 91402

  • Clinical Research Partners, LLC

    Petersburg, Virginia, 23805

  • AIM Trials

    Plano, Texas, 75093

  • Research Across America

    Plano, Texas, 75093

  • Carilion Medical Center

    Roanoke, Virginia, 24014

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • University of California Davis Medical Center MIND Institute

    Sacramento, California, 95817

  • Attalla Consultants, LLC dba Institute for Behavioral Medicine

    Smyrna, Georgia, 30082-2629

  • Family Psychiatry Of The Woodlands

    The Woodlands, Texas, 77381

  • Sleep and Behavior Medicine Institute

    Vernon Hills, Illinois, 60061

  • Children's National Health System

    Washington D.C., District of Columbia, 20010

  • Elite Clinical Trials, Incorporated

    Wildomar, California, 92595

Other trials in United States

Ukraine4 sites

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

    Dnipro, 49027

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

    Dnipro, 49101

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

    Odesa, 65006

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

    Vinnytsia, 21018

Other trials in Ukraine

About this study

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)

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).

Being tested
placebo oral capsules, ziprasidone oral capsules
Keywords
Bipolar I Disorder (current or most recent episode manic). Children and adolescents aged 10 to 17 years.
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placebo oral capsulesDrug

    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.

  • ziprasidone oral capsulesDrug

    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.

Study groups in NCT02075047
Study groupRoleWhat they receive
1Placebo comparatorNot described
Receives: Drug: placebo oral capsules
ziprasidoneExperimentalNot described
Receives: Drug: ziprasidone oral capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 4

Secondary outcomes (3)

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

    CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill), higher scores indicated more severity of illness.

    Measured: Baseline, Week 1, 2, 3, 4

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

    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.

    Measured: Baseline, Week 1, 2, 3

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

    CGI-I: 7-point clinician rated scale which rates the participant's improvement or worsening from baseline, ranging from 1 (very much improved) to 7 (very much worse), higher scores indicate less improvement.

    Measured: Baseline, Week 1, 2, 3, 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2014 (estimated)
  2. Study start23 May 2014
  3. Primary completion11 Apr 2020
  4. Study completion18 May 2020

Why it stopped: Based on recent input from FDA, the pre-specified final analysis will be performed at the current enrollment using a re-estimation of the sample size.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02075047
Sponsor's protocol ID
A1281198
Status last verified
Jun 2021
First submitted
27 Feb 2014
Last updated
16 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • 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.

    PubMed 35394365

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ziprasidone oral capsules in people with Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 50 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4 (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02075047, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.

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