Phenylketonuria Trial, Recruiting NCT06560736 Sponsor: University of Missouri-Columbia Condition: Phenylketonuria
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Phenylketonuria Trial, Recruiting

NCT06560736
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:

  • The participant must be a young person between 10 and 17 years old, and at least one parent or guardian must also take part
  • The young person must have a formal diagnosis of PKU (a condition affecting how the body processes a protein called phenylalanine), identified through newborn screening with a specific blood test result, and must have started treatment within the first 30 days of life
  • The young person and/or their parent must be interested in taking part in a short, skills-based mental health program aimed at preventing or managing feelings of anxiety and/or depression
  • The family must currently live in Missouri, Kansas, or Illinois

Who may not be able to join:

  • Young people who have a significant intellectual disability or significant difficulty with understanding or expressing language that would make it hard to take part in talking-based therapy (as reported by the young person or parent)
  • Those who are planning to receive other therapy or counselling outside of this study during the time they would be taking part
  • Those who are planning to change any current mental health or PKU-related medications during the time they would be taking part
  • Young people who are currently having serious thoughts of suicide that would require immediate or more intensive professional support than a brief therapy program can provide (confirm with trial site)

⚠️ 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 28 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

Phone: 573-884-8140

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
Sponsor
University of Missouri-Columbia
Registry
ClinicalTrials.gov
Start date
1 October 2024
Est. completion
31 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

PROMIS Anxiety & Depression scales; Test My Brain phone-based EMA cognitive test

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: 28 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