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Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA) for Bipolar Disorder (IGNITE Trial)

N/A

Waitlist Available

Led By Martha Sajatovic, MD

Research Sponsored by Case Western Reserve University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 24 weeks

Awards & highlights

IGNITE Trial Summary

This trial will test a customized adherence enhancement intervention developed by the investigative team to see if it is effective in bipolar disorder adults in a high-risk, high-need group: AYAs with BD who are poorly adherent with prescribed BD medications.

Eligible Conditions

Bipolar Disorder

IGNITE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in the Tablet Routine Questionaire (TRQ) "past month" item at 24 weeks

Change from baseline in the Tablet Routine Questionaire (TRQ) "past week" item at 24 weeks

Change from baseline in treatment adherence as measured by special pill counter at 24 weeks

IGNITE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Customized Adherence Enhancement for AYAExperimental Treatment1 Intervention

This arm will receive the experimental intervention, Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA).

Group II: Enhanced Treatment as Usual (ETAU)Active Control1 Intervention

This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA)

2021

N/A

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor

299 Previous Clinical Trials

259,914 Total Patients Enrolled

12 Trials studying Bipolar Disorder

1,171 Patients Enrolled for Bipolar Disorder

Martha Sajatovic, MDPrincipal Investigator - Case Western Reserve University

Case Western Reserve University

20 Previous Clinical Trials

1,530 Total Patients Enrolled

11 Trials studying Bipolar Disorder

841 Patients Enrolled for Bipolar Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently engaged in this research endeavor?

"Affirmative. Clinicaltrials.gov provides evidence that this experiment, which was initially advertised on March 15th 2021, is actively enrolling patients. Specifically, 40 individuals are needed from 2 different medical institutions."

Answered by AI

Might I be qualified to partake in this research?

"This trial is looking for 40 adolescents aged between 14 - 21 who have been diagnosed with manic disorder. To be eligible, participants must exhibit inadequate adherence to prescribed medications such as mood stabilizers or antipsychotics, and meet the DSM-5 criteria for bipolar type I or II as evaluated by a SCID-5 assessment. Those under 18 will also need written assent from guardians alongside consent; all applicants should possess English fluency."

Answered by AI

Are persons under the age of 80 admissible to participate in this research?

"The criteria for this trial specifies that its participants must be between the ages of 14 and 21. This study contains a total of 35 patients below 18 years old, while those over 65 are represented by 114 individuals."

Answered by AI

Are there available slots for individuals to join this experiment?

"As detailed on clinicaltrials.gov, this research project continues to seek out eligible participants; the initial post was dated March 15th 2021 and a recent update occurred October 2nd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Adherence in Adolescents and Young Adults With Bipolar Disorder

Martha Sajatovic, MD 2021. "Improving Adherence in Adolescents and Young Adults With Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04348604.