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New program aims to boost medication adherence in bipolar youth

NCT ID NCT04348604

Disease control Sponsor: Case Western Reserve University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a behavioral program called CAE-AYA to help teens and young adults with bipolar disorder take their medication more consistently. The program included up to five in-person sessions and a follow-up phone call over eight weeks. Researchers measured adherence using questionnaires and a special pill bottle that records when it's opened. The goal was to see if this approach could improve medication routines and reduce the risk of relapse and suicide in this high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA) - a behavioral program
What this could lead to
If successful, this program could help young people with bipolar disorder stick to their medication routine, potentially reducing relapses and suicide risk.
What could go wrong
This is a small, completed study with only 36 participants, so results may not apply to everyone. The program requires in-person sessions, which may not be practical for all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

36 people

The number who actually took part.

Started

Mar 2021

Finished

Sep 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * DSM-5 diagnosis of bipolar disorder (BD), type I or II as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-5) * Poor adherence defined as missing ≥ 20% of prescribed evidence-based BD medications, i.e., mood stabilizer (e.g., lithium, valproic acid, or carbamazepine) or second generation antipsychotics, on the TRQ for the past week or past month * If \< 18 years, able and willing to give written informed assent and have a legal guardian provide written informed consent; if \> 18 years, able and willing to provide written informed consent * Fluent in English Exclusion Criteria: * Unable to receive care in the outpatient setting due to illness severity * A DSM-5 diagnosis of an autism spectrum disorder or primary psychotic disorder * Documented or suspected IQ \< 70 * Prior enrollment in CAE or Phase 2 * Have recently (in the past month) started a new psychotherapy/behavioral intervention

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Conditions

The condition(s) this trial relates to.

bipolar disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar disorder

Contacts and locations

Locations

  • Case Western Reserve Universty

    Cleveland, Ohio, 44106, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

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