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TerminatedNCT02075047

Ziprasidone oral capsules for Bipolarity

This study was terminated in the United States and in Ukraine. It is testing ziprasidone oral capsules for Bipolarity.

BipolarityDrugFrom 10 Years to 17 Years

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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In plain English

Key information made simple

What is this study testing?

This study is testing whether Flexible Doses of Oral Ziprasidone may be useful for adolescents experiencing bipolarity.

What would participation involve?

Participants may receive Flexible Doses of Oral Ziprasidone, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Ukraine and in the United States.

Who is it mainly for?

This study appears to be mainly for adolescents with bipolarity. Because it involves minors, a parent or guardian may need to be involved.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, what role parents or guardians have in the process.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)

  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: May 23, 2014
Recruitment status
Terminated
Enrollment listed in the registry
171
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Sponsor type
Other organization
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, Ukraine
Age range
From 10 Years to 17 Years
Official registry ID
NCT02075047
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)

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Study ID: NCT02075047. We help you review the study, but cannot decide medical eligibility.

Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Ukraine · 4 sites
  • Communal Non profit Enterprise "City Children Clinical Hospital #5 of Dnipro Regional Council"
    Dnipro
    Site status: Not listed — confirm with the team
  • Communal Nonprofit Enterprise "City Children Clinical Hospital #5 of Dnipro Regional Council
    Dnipro
    Site status: Not listed — confirm with the team
  • Communal Nonprofit Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa
    Odesa
    Site status: Not listed — confirm with the team
  • Municipal Institution "Vinnytsya Regional Psychoneurologycal Hospital Named After O.I. Yushenko"
    Vinnytsia
    Site status: Not listed — confirm with the team
United States · 46 sites
  • Harmonex Neuroscience Research, Inc.
    Dothan, Alabama
    Site status: Not listed — confirm with the team
  • Woodland International Research Group Inc.
    Little Rock, Arkansas
    Site status: Not listed — confirm with the team
  • Woodland International Research Group, LLC
    Little Rock, Arkansas
    Site status: Not listed — confirm with the team
  • California Pharmaceutical Research Institute
    Anaheim, California
    Site status: Not listed — confirm with the team
  • NRC Research Institute
    Orange, California
    Site status: Not listed — confirm with the team
  • Asclepes Research Centers
    Panorama City, California
    Site status: Not listed — confirm with the team
  • University of California Davis Medical Center MIND Institute
    Sacramento, California
    Site status: Not listed — confirm with the team
  • Elite Clinical Trials, Incorporated
    Wildomar, California
    Site status: Not listed — confirm with the team
  • Children's National Health System
    Washington D.C., District of Columbia
    Site status: Not listed — confirm with the team
  • Da Vinci Research Institute Inc
    Boca Raton, Florida
    Site status: Not listed — confirm with the team
  • Sarkis Clinical Trials
    Gainesville, Florida
    Site status: Not listed — confirm with the team
  • Medical Research Group of Central Florida
    Orange City, Florida
    Site status: Not listed — confirm with the team
  • APG Research LLC
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • Atlanta Center for Medical Research
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Inova Clinical Trials and Research Centre
    Fayetteville, Georgia
    Site status: Not listed — confirm with the team
  • Attalla Consultants, LLC dba Institute for Behavioral Medicine
    Smyrna, Georgia
    Site status: Not listed — confirm with the team
  • Sleep and Behavior Medicine Institute
    Vernon Hills, Illinois
    Site status: Not listed — confirm with the team
  • Hugo W. Moser Research Institute at Kennedy Krieger Institute Clinical Trials Unit
    Baltimore, Maryland
    Site status: Not listed — confirm with the team
  • Kennedy Krieger Institute Inpatient Clinic
    Baltimore, Maryland
    Site status: Not listed — confirm with the team
  • Kennedy Krieger Institute Outpatient Clinic
    Baltimore, Maryland
    Site status: Not listed — confirm with the team
  • Psychiatric Mental Health Program at Kennedy Krieger Institute Clinical Trials Unit
    Baltimore, Maryland
    Site status: Not listed — confirm with the team
  • Johns Hopkins Hospital Pediatric Clinical Research Unit
    Baltimore, Maryland
    Site status: Not listed — confirm with the team
  • Charlotte R. Bloomberg Children's Center
    Baltimore, Maryland
    Site status: Not listed — confirm with the team
  • Johns Hopkins Hospital Investigational Drug Services
    Baltimore, Maryland
    Site status: Not listed — confirm with the team
  • Clinical Research Integrity(CRI) Lifetree, LLC
    Marlton, New Jersey
    Site status: Not listed — confirm with the team
  • Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
    Buffalo, New York
    Site status: Not listed — confirm with the team
  • The Zucker Hillside Hospital Northwell Health
    Glen Oaks, New York
    Site status: Not listed — confirm with the team
  • Manhattan Behavioral Medicine
    New York, New York
    Site status: Not listed — confirm with the team
  • Finger Lakes Clinical Research
    Rochester, New York
    Site status: Not listed — confirm with the team
  • University of Cincinnati
    Cincinnati, Ohio
    Site status: Not listed — confirm with the team
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio
    Site status: Not listed — confirm with the team
  • The Ohio State University
    Columbus, Ohio
    Site status: Not listed — confirm with the team
  • Sooner Clinical Research
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Cutting Edge Research Group
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Paradigm Research Professionals, LLC
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • UT Health Science Center at Houston (UTHSC-H)
    Houston, Texas
    Site status: Not listed — confirm with the team
  • AIM Trials
    Plano, Texas
    Site status: Not listed — confirm with the team
  • Research Across America
    Plano, Texas
    Site status: Not listed — confirm with the team
  • Family Psychiatry Of The Woodlands
    The Woodlands, Texas
    Site status: Not listed — confirm with the team
  • Fontaine Medical Laboratories
    Charlottesville, Virginia
    Site status: Not listed — confirm with the team
  • Northridge Medical Plaza
    Charlottesville, Virginia
    Site status: Not listed — confirm with the team
  • University of Virginia Center for Psychopharmacology Research in Youth
    Charlottesville, Virginia
    Site status: Not listed — confirm with the team
  • UVA Child & Family Psychiatry Clinic
    Charlottesville, Virginia
    Site status: Not listed — confirm with the team
  • Clinical Research Partners, LLC
    Petersburg, Virginia
    Site status: Not listed — confirm with the team
  • Carilion Medical Center
    Roanoke, Virginia
    Site status: Not listed — confirm with the team
  • Eastside Therapeutic Resource dba Core Clinical Research
    Everett, Washington
    Site status: Not listed — confirm with the team
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with bipolarity. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving placebo oral capsules, ziprasidone oral capsules. Phase 3 studies are usually larger and aim to confirm effectiveness and safety in a broader group.

Who might this study be for?

This study may concern people with bipolarity; age range: From 10 Years to 17 Years. The criteria appear fairly specific, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc., which appears to be another type of organization. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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