RETRIAL Study

Mental Health arm

For people who had mental health symptoms on TRIKAFTA

The RETRIAL Mental Health arm is for PWCF who experienced new or worsening mental health symptoms (such as mood changes, anxiety, depression, sleep issues, or problems with thinking or memory) while taking TRIKAFTA (elexacaftor / tezacaftor / ivacaftor) and are now starting ALYFTREK (vanzacaftor / tezacaftor / deutivacaftor) for the first time.

Shared eligibility

Everyone in RETRIAL meets these baseline criteria.

  • PWCF ages 6 and older

  • Planning to start ALYFTREK for the first time with your CF care team

Mental Health arm

You may be eligible if…

  • Had new or worsening mental health symptoms (such as mood changes, anxiety, depression, sleep issues, or problems with thinking or memory) while on TRIKAFTA
  • Had to change the TRIKAFTA dose or stop TRIKAFTA because of those symptoms
  • Starting ALYFTREK for the first time

OPTIONAL NEUROCOGNITIVE SUB-STUDY

For those who experienced brain fog, or issues with attention, memory, and word finding. The optional Neurocognitive component (ages 7+) sits within the mental health arm for those who also have brain fog, memory issues, or difficulty concentrating.

  • Requires an in-person visit.
Optional biobanking is available alongside this arm.
  • Requires an in-person visit.

This study may not be a fit for…

  • People who are pregnant or breastfeeding
  • People on the transplant list, or within 3 months after a transplant
  • People who cannot access ALYFTREK
  • People who have already taken ALYFTREK — RETRIAL only follows people starting it for the first time
Each CF center has its own process for review. Your CF care team is the best resource to help decide if the study is right for you. They can also connect you with a participating site.

What to expect

Participation is voluntary. You can ask questions at any time, and you can stop at any time. See the FAQ section for additional information.

  1. Step 1

    Talk with your CF care team

    Your CF doctor or coordinator will explain the study and answer any questions before you decide.

  2. Step 2

    Surveys every two weeks

    Brief online surveys with questions about mood changes, anxiety, depression, sleep issues, or problems with thinking or memory. Most take just a few minutes.

  3. Step 3

    Daily diary for the first 6 weeks

    A quick daily check-in on your phone every day before and after you start ALYFTREK to see how you are feeling that day.

  4. Optional

    Optional thinking tests (Ages 7+)

    Requires an in-person visit. Short memory and attention tests on an iPad; under 25 minutes, before and after starting ALYFTREK.

  5. Optional

    Optional samples (Biobank)

    Requires an in-person visit. You may choose to share blood, stool, AND/OR nasal swab samples to help researchers learn more.

See the Liver Eligibility