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CompletedNCT00350857

Effectiveness of Extended-Release Carbamazepine in manic episodes in bipolarity type I

This study is completed in the United States. It is testing Extended-Release Carbamazepine for manic episodes in bipolarity type I.

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 Extended-Release Carbamazepine may be useful for adolescents experiencing bipolarity.

What would participation involve?

Participants may receive Extended-Release Carbamazepine, attend study visits with the research team. The registry lists locations 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 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 dateJuly 2006
Recruitment status
Completed
Enrollment listed in the registry
161
Sponsor
Validus Pharmaceuticals
Sponsor type
Unknown or unclear
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 4Usually happens after approval, to monitor real-world use, safety, and longer-term outcomes.
Locations
United States
Age range
From 10 Years to 17 Years
Official registry ID
NCT00350857
Official title
A Phase IV, Multi-Center, Open-Label, Safety and Effectiveness Study of Extended-Release Carbamazepine in the Treatment of Mania in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder.

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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.

United States · 26 sites
  • 11 Shire Clinical Research Site
    Altamonte Springs, Florida
    Site status: Not listed — confirm with the team
  • 17 Segal Institute for Clinical Research
    Fort Lauderdale, Florida
    Site status: Not listed — confirm with the team
  • 19 Sarkis Clinical Trials
    Gainesville, Florida
    Site status: Not listed — confirm with the team
  • 23 Shire Clinical Research Site
    Jacksonville, Florida
    Site status: Not listed — confirm with the team
  • 21 Scientific Clinical Research
    North Miami, Florida
    Site status: Not listed — confirm with the team
  • 14 Northlake Medical Research
    Decatur, Georgia
    Site status: Not listed — confirm with the team
  • 04 Mountain West Clinical Trials
    Eagle, Idaho
    Site status: Not listed — confirm with the team
  • 25 Capstone Clinical Research
    Libertyville, Illinois
    Site status: Not listed — confirm with the team
  • 15 Psychiatric Associates
    Overland Park, Kansas
    Site status: Not listed — confirm with the team
  • 27 Owensboro Behavioral Care
    Owensboro, Kentucky
    Site status: Not listed — confirm with the team
  • 05 Brentwood Research Institute
    Shreveport, Louisiana
    Site status: Not listed — confirm with the team
  • 13 Pharmasite Research, Inc
    Baltimore, Maryland
    Site status: Not listed — confirm with the team
  • 02 Finger Lakes Clinical Research
    Rochester, New York
    Site status: Not listed — confirm with the team
  • 01 Nccacrf
    Chapel Hill, North Carolina
    Site status: Not listed — confirm with the team
  • 06 University of Cincinnati, College of Medicine
    Cincinnati, Ohio
    Site status: Not listed — confirm with the team
  • 09 Discovery and Wellness Center for Children
    Cleveland, Ohio
    Site status: Not listed — confirm with the team
  • 03 IPS Research
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • 26 Suburban Research Associates
    Media, Pennsylvania
    Site status: Not listed — confirm with the team
  • 12 Claghorn-Lesem Research Clinic
    Bellaire, Texas
    Site status: Not listed — confirm with the team
  • 07 Center for Pediatric Psychiatry
    Dallas, Texas
    Site status: Not listed — confirm with the team
  • 24 Red Oak Psychiatry Associates
    Houston, Texas
    Site status: Not listed — confirm with the team
  • 10 RID Clinical Research, Inc
    Lake Jackson, Texas
    Site status: Not listed — confirm with the team
  • 08 Dominion Clinical Research
    Midlothian, Virginia
    Site status: Not listed — confirm with the team
  • 22 Brighton Research Group
    Virginia Beach, Virginia
    Site status: Not listed — confirm with the team
  • 20 Shire Clinical Research Site
    Milwaukee, Wisconsin
    Site status: Not listed — confirm with the team
  • 16 Rogers Center for Research and Training
    Milwaukee, Wisconsin
    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 Extended-Release Carbamazepine. Phase 4 studies usually happen after treatment approval, to monitor real-world use.

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 Validus Pharmaceuticals, which appears to be unknown or unclear. 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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