Improving Adherence in Adolescents and Young Adults With Bipolar Disorder (NCT04348604) | Clinical Trial Compass
CompletedNot Applicable
Improving Adherence in Adolescents and Young Adults With Bipolar Disorder
United States36 participantsStarted 2021-03-15
Plain-language summary
Although poor medication adherence occurs in more than 65% of adolescent and young adults (AYA) with bipolar disorder (BD) and is associated with poor recovery, high rates of relapse, and a 5.2 fold increased suicide risk, there have been no interventions that specifically target adherence in AYA with BD. This proposal will modify and test a customized adherence enhancement (CAE) intervention developed by the investigative team and found to be effective in BD adults in a high-risk, high-need group: AYAs with BD who are poorly adherent with prescribed BD medications. The project addresses the critical need for evidence-based interventions to improve adherence in AYAs with BD and has the potential to change outcome trajectories in high-risk young people with BD as they transition to adulthood.
Who can participate
Age range
14 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Month" Item at 24 Weeks
Timeframe: Baseline and 24 weeks
2
Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Week" Item at 24 Weeks
Timeframe: Baseline and 24 weeks
3
Change From Baseline in Treatment Adherence as Measured by Special Pill Counter at 24 Weeks