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RecruitingNCT06372964

Lumateperone for depression in bipolarity

The registry lists this study as recruiting. Study locations are listed in the United States, in Colombia, in India, ... Confirm recruitment at each site. It is testing lumateperone for depression in bipolarity.

Bipolarity, DepressionDrugFrom 10 Years to 17 Years
In plain English

Key information made simple

What is this study testing?

This study is testing whether Lumateperone may be useful for adolescents experiencing bipolarity.

What would participation involve?

Participants may receive Lumateperone, complete questionnaires or follow-up assessments, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Colombia, in India, and in Serbia.

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 14, 2024
Recruitment status
Recruiting
Enrollment listed in the registry
384
Sponsor
Intra-Cellular Therapies, 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, Colombia, India, ...
Age range
From 10 Years to 17 Years
Official registry ID
NCT06372964
Official title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years

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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.

Colombia · 4 sites
  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
    Barranquilla
    Site status: Recruiting
  • Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO
    Bello
    Site status: Recruiting
  • Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
    Bogotá
    Site status: Completed
  • Psynapsis Salud Mental S.A.
    Pereira
    Site status: Suspended
India · 4 sites
  • Ratandeep Surgical Hospital And Endoscopy Clinic
    Ahmedabad
    Site status: Suspended
  • Society for Psychiatric Update and Research Shanti Nursing Home
    Aurangabad
    Site status: Suspended
  • Chopda Medicare & Research Centre
    Nashik
    Site status: Suspended
  • Deva Institute of Healthcare And Research Pvt Ltd
    Varanasi
    Site status: Suspended
Serbia · 4 sites
  • Clinic of Neurology and Psychiatry for Children and Youth
    Belgrade
    Site status: Active Not Recruiting
  • Institute of Mental Health Serbia
    Belgrade
    Site status: Active Not Recruiting
  • University Clinical Center NIS
    Niš
    Site status: Active Not Recruiting
  • Clinical Center of Vojvodina
    Novi Sad
    Site status: Suspended
United States · 56 sites
  • Harmonex Neuroscience Research
    Dothan, Alabama
    Site status: Recruiting
  • Pillar Clinical Research, LLC
    Little Rock, Arkansas
    Site status: Recruiting
  • Advanced Research Center, Inc
    Anaheim, California
    Site status: Recruiting
  • Inland Psychiatric Medical Group Inc
    Redlands, California
    Site status: Recruiting
  • UC Davis Health System
    Sacramento, California
    Site status: Recruiting
  • University of California San Diego Medical Center
    San Diego, California
    Site status: Completed
  • Next Level Clinical Trials, LLC
    West Covina, California
    Site status: Recruiting
  • MCB Clinical Research Centers LLC
    Colorado Springs, Colorado
    Site status: Completed
  • Royal Palm Clinical Research
    Fort Myers, Florida
    Site status: Suspended
  • United Research Institute
    Hialeah, Florida
    Site status: Completed
  • Advanced Research Institute of Miami
    Homestead, Florida
    Site status: Suspended
  • Vital Care Research
    Miami, Florida
    Site status: Suspended
  • Columbus Clinical Services LLC
    Miami, Florida
    Site status: Suspended
  • Care Research Center Inc
    Miami, Florida
    Site status: Recruiting
  • HealthMed Clinical Center Inc
    Miami, Florida
    Site status: Recruiting
  • Ocean Blue Medical Research Center Inc.
    Miami, Florida
    Site status: Completed
  • AP Medical Research
    Miami, Florida
    Site status: Suspended
  • Envision Trials LLC
    Miami, Florida
    Site status: Recruiting
  • GTL Medical and Research Group
    Miami, Florida
    Site status: Completed
  • Links Clinical Trials
    Miami, Florida
    Site status: Recruiting
  • SouthGen Clinical Research LLC
    Miami, Florida
    Site status: Completed
  • New Med Research Inc
    Miami Gardens, Florida
    Site status: Recruiting
  • The Angel Medical Research Corporation
    Miami Gardens, Florida
    Site status: Recruiting
  • Riveldi Biomedical Research
    Miami Lakes, Florida
    Site status: Recruiting
  • APG Research LLC
    Orlando, Florida
    Site status: Recruiting
  • Health Synergy Clinical Research
    West Palm Beach, Florida
    Site status: Recruiting
  • CenExeli Research LLC
    Atlanta, Georgia
    Site status: Recruiting
  • Advanced Discovery Research
    Atlanta, Georgia
    Site status: Completed
  • Salveo Integrative Health Inc
    Lawrenceville, Georgia
    Site status: Completed
  • CenExeli Research LLC 1
    Savannah, Georgia
    Site status: Recruiting
  • Ann & Robert H. Lurie Children's Hospital of Chicago
    Chicago, Illinois
    Site status: Recruiting
  • Revive Research Institute
    Elgin, Illinois
    Site status: Recruiting
  • Indiana University
    Indianapolis, Indiana
    Site status: Completed
  • MTP Psychiatry LLC
    Baltimore, Maryland
    Site status: Completed
  • Neurobehavioral Medicine Group
    Bloomfield Hills, Michigan
    Site status: Recruiting
  • Midwest Research Group
    Saint Charles, Missouri
    Site status: Recruiting
  • Washington University School of Medicine Child and Adolescent Psychiatry Clinic
    St Louis, Missouri
    Site status: Completed
  • Alivation Research LLC
    Lincoln, Nebraska
    Site status: Recruiting
  • NYU Child Study Center
    New York, New York
    Site status: Recruiting
  • Haidar Almhana Nieding
    Avon Lake, Ohio
    Site status: Completed
  • University of Cincinnati Medical Center
    Cincinnati, Ohio
    Site status: Recruiting
  • Charak Center for Health and Wellness
    Garfield Heights, Ohio
    Site status: Recruiting
  • Westlake America Clinic
    Westlake, Ohio
    Site status: Completed
  • SP Research, PLLC (dba Rivus Wellness & Research Institute)
    Oklahoma City, Oklahoma
    Site status: Recruiting
  • Cutting Edge Research Group
    Oklahoma City, Oklahoma
    Site status: Completed
  • Sooner Clinical Research
    Oklahoma City, Oklahoma
    Site status: Recruiting
  • The University of Texas at Austin
    Austin, Texas
    Site status: Recruiting
  • BioBehavioral Research of Austin PC
    Austin, Texas
    Site status: Completed
  • REX Clinical Trials LLC
    Beaumont, Texas
    Site status: Recruiting
  • North Pointe Psychiatry
    Flower Mound, Texas
    Site status: Completed
  • Kaleidoscope Clinical Research
    Houston, Texas
    Site status: Recruiting
  • Red Oak Psychiatry Associates
    Houston, Texas
    Site status: Recruiting
  • Perceptive Pharma Research
    Richmond, Texas
    Site status: Recruiting
  • Virginia Commonwealth University
    Richmond, Virginia
    Site status: Recruiting
  • Northwest Clinical Research Center
    Bellevue, Washington
    Site status: Recruiting
  • Core Clinical Research
    Everett, Washington
    Site status: Recruiting
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. It includes a comparison with placebo. 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 Lumateperone, Placebo. 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 broad, 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 Intra-Cellular Therapies, Inc., which appears to be another type of organization. The listed contact or investigator is Intra-Cellular Therapies, Inc., affiliated with Intra-Cellular Therapies, Inc.. 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 recruiting. Individual sites may have different statuses. The research team must confirm whether a site is open and whether you meet the criteria.

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