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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 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.

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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.

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

FieldValue
Enrollment Target 36 participants
Start Date 2021-03-15
Est. Completion 2023-09-01
Phase NA

Sponsor

Case Western Reserve University

141 total trials

What the Registry Record Tells You About NCT04348604

The ClinicalTrials.gov registry entry for NCT04348604 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (89% lower). The listed sponsor is Case Western Reserve University, which has 141 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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