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NCT04348604 · ClinicalTrials.gov registry record · NA
Improving Adherence in Adolescents and Young Adults With Bipolar Disorder
A NA study of Bipolar Disorder, sponsored by Case Western Reserve University.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT04348604: Completed NA study of Bipolar Disorder, sponsored by Case Western Reserve University.
NCT04348604 is a NA study of Bipolar Disorder that has completed, run by Case Western Reserve University. The registered enrollment target is 36 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04348604, a NA study of Bipolar Disorder, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month.
Conditions Studied
Interventions
- BEHAVIORAL Enhanced Treatment as Usual (ETAU)
- BEHAVIORAL Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA)
Study Locations (2)
Ohio
- University of Cincinnati - Cincinnati
- Case Western Reserve Universty - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2023-09-01 |
| Phase | NA |
What the finished NCT04348604 record still lists
NCT04348604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Enhanced Treatment as Usual (ETAU) is the first listed.
NCT04348604 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04348604 about?
NCT04348604 is a clinical study titled "Improving Adherence in Adolescents and Young Adults With Bipolar Disorder". 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 wi...
What is the current status of trial NCT04348604?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2021-03-15. Estimated completion is 2023-09-01.
What conditions does trial NCT04348604 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT04348604?
The interventions under investigation include: Enhanced Treatment as Usual (ETAU) (BEHAVIORAL), Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04348604?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04348604 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04348604's enrollment target sits among peer trials
36 129th of 162 higher than 33 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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