Bipolar Disorder Trial, Recruiting NCT07622927 Sponsor: University of Texas Southwestern Medical Center Condition: Bipolar Disorder
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Bipolar Disorder Trial, Recruiting

NCT07622927
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

This trial has three separate groups. People may be considered for one of the following:

Group A – Parents with Bipolar Disorder:

  • Adults aged 18 or older
  • People who have been diagnosed with Bipolar I or II disorder at some point in their lifetime, confirmed by a clinician
  • People who have at least one biological child between the ages of 7 and 21
  • People who are willing and able to give informed consent to participate
  • People who are able to take part in study activities such as co-design sessions, interviews, and assessments
  • People who can read, speak, and understand English

Group B – Adult Caregivers:

  • Adults aged 18 or older
  • Adults who are the main caregiver responsible for the daily care and/or medical decisions of a child aged 7–21, for at least 6 months, where that child's biological parent has a clinician-confirmed lifetime diagnosis of Bipolar I or II disorder
  • People who are willing and able to give informed consent to participate
  • People who are able to take part in study activities such as co-design sessions, interviews, and assessments
  • People who can read, speak, and understand English

Group C – Young People at Risk:

  • Young people aged 13–18 for the earlier phases of the study (co-design, alpha testing, and beta testing), or aged 7–21 for the screening phase
  • Young people who do not currently have a diagnosis of Bipolar I or II disorder
  • Young people who have at least one biological parent with a clinician-confirmed lifetime diagnosis of Bipolar I or II disorder
  • For young people aged 18–21: those who are willing and able to give verbal informed consent themselves
  • For young people aged 7–21: those whose parent, guardian, or legal authorised representative is willing and able to give verbal informed consent, and where the young person is also able to give their verbal agreement (assent)
  • Young people who are willing and able to take part in study activities such as discussions, questionnaires, or screening assessments
  • Young people with enough English to understand the study materials and procedures

Who may not be able to join:

  • People who are unable to give informed consent due to cognitive difficulties or language barriers
  • People who are experiencing acute psychiatric instability at the time of enrolment, such as active psychosis or suicidal crisis that has not been stabilised
  • People who have a medical or psychiatric condition that, in the judgement of the Principal Investigator or study clinician, could put them at undue risk or interfere with their standard clinical care

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Karabi Nandy, PhD, University of Texas Southwestern Medical Center

Phone: 214-648-4490

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
11 March 2026
Est. completion
30 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Decision Aid Acceptability Score; Decision Aid Usability Score; Youth Screening Uptake Rate; Youth Screening Completion Rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov