This study is completed in the United States, in France, in Bulgaria, .... It is testing lurasidone for depression.
Bipolarity, DepressionDrugFrom 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 Lurasidone may be useful for adolescents experiencing bipolarity.
What would participation involve?
Participants may receive Lurasidone, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Bulgaria, in Colombia, and in France.
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.
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
What are the exact eligibility criteria, and what could exclude someone?
How many visits, assessments, or follow-ups are expected, and over what period?
What risks, side effects, practical burdens, or alternatives should be understood first?
Who should be contacted to confirm locations, timing, compensation, and next steps?
Study clarity
Things to check before joining
Study start dateMarch 2014
Recruitment status
Completed
Enrollment listed in the registry
350
Sponsor
Sumitomo Pharma America, Inc.
Sponsor type
Pharmaceutical company
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, France, Bulgaria, ...
Age range
From 10 Years to 17 Years
Official registry ID
NCT02046369
Official title
A Randomized, 6-Week, Double-blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Bipolar I Depression
Ask HopeStage to help me review this study
This record does not confirm open recruitment. We can help you understand it and explore other studies.
Study ID: NCT02046369. 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.
Chair of Psychiatry and Narcology, Vinnytsia National Medical University, O.I. Yushchenko Regional Psychoneurological Hospital
Vinnytsia
Site status: Not listed — confirm with the team
United States · 30 sites
Harmonex Neuroscience Research
Dothan, Alabama
Site status: Not listed — confirm with the team
ProScience Research Group
Culver City, California
Site status: Not listed — confirm with the team
Hartford Hospital
Hartford, Connecticut
Site status: Not listed — confirm with the team
Sarkis Clinical Trials - Parent
Gainesville, 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
Attalla Consultants, LLC
Smyrna, Georgia
Site status: Not listed — confirm with the team
Capstone Clinical Research, Inc.
Libertyville, Illinois
Site status: Not listed — confirm with the team
Psychiatric Associates
Overland Park, Kansas
Site status: Not listed — confirm with the team
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana
Site status: Not listed — confirm with the team
Kennedy Krieger Institute
Baltimore, Maryland
Site status: Not listed — confirm with the team
Neurobehavioral Medicine Group, PLLC
Bloomfield Hills, Michigan
Site status: Not listed — confirm with the team
St. Charles Psychiatric Associates
Saint Charles, Missouri
Site status: Not listed — confirm with the team
Jersey Shore University Medical Center
Neptune City, New Jersey
Site status: Not listed — confirm with the team
North Shore/Long Island Jewish PRIME
Glen Oaks, New York
Site status: Not listed — confirm with the team
Bioscience Research, LLC
Mount Kisco, 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
Richmond Behavioral Associates
Staten Island, New York
Site status: Not listed — confirm with the team
University of Cincinnati Medical Center
Cincinnati, Ohio
Site status: Not listed — confirm with the team
University Hospitals Case Medical Center
Cleveland, Ohio
Site status: Not listed — confirm with the team
Cutting Edge Research of Enid
Oklahoma City, Oklahoma
Site status: Not listed — confirm with the team
Research Strategies of Memphis, LLC
Memphis, Tennessee
Site status: Not listed — confirm with the team
BioBehavioral Research of Austin
Austin, Texas
Site status: Not listed — confirm with the team
Pillar Clinical Research, LLC
Dallas, Texas
Site status: Not listed — confirm with the team
Family Psychiatry of The Woodlands, P.A.
The Woodlands, Texas
Site status: Not listed — confirm with the team
Ericksen Research & Development, LLC
Clinton, Utah
Site status: Not listed — confirm with the team
Aspen Clinical Research
Orem, Utah
Site status: Not listed — confirm with the team
University of Virginia
Charlottesville, Virginia
Site status: Not listed — confirm with the team
Clinical Research Partners, LLC
Petersburg, Virginia
Site status: Not listed — confirm with the team
Pacific Institute Of Medical Sciences
Bothell, 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 Lurasidone, 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 Sumitomo Pharma America, Inc., which appears to be a pharmaceutical company. 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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