Improving Adherence in Adolescents and Young Adults With Bipolar Disorder (IGNITE)

April 28, 2026 updated by: Martha Sajatovic, MD, Case Western Reserve University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve Universty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Customized Adherence Enhancement for AYA
This arm will receive the experimental intervention, Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA).
Behavioral: Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA)
Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA): CAE-AYA participants will have 4 core in-person sessions (45-60 minutes each) spaced about 1 week apart over a period of approximately 4 weeks and one "booster" in-person session approximately 4 weeks after completion of the 4 core sessions (total of up to 5 in-person sessions spaced out over 8 weeks). There will be one follow-up phone call with a study interventionist, approximately 6 weeks post-baseline (timed half-way between completion of the core sessions and the "booster" session). All AYAs assigned to the CAE-AYA arm will receive all 4 modules (Psychoeducation on BD Medications; Communication with Providers & Caregivers; Medication Routines; and Targeting Risky Behavior via Modified Motivational Enhancement Therapy (MET)), with the content within each module being customized to developmental stage and behavioral experience.
Active Comparator: Enhanced Treatment as Usual (ETAU)
This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU).
Behavioral: Enhanced Treatment as Usual (ETAU)
Enhanced Treatment as Usual (ETAU): ETAU will consist of usual clinical care with prescribing clinicians and therapists, augmented by written materials specific to BD for AYAs and 6 follow-up telephone calls to briefly review the materials and be available for questions by social workers with mental health experience and at least some experience in working with AYA with BD. In order to ensure that there is not treatment contamination, different trained interventionists will be used for CAE and eTAU. Therapists will briefly review the materials and be available for questions during the phone calls. Materials will cover general self-management in BD. The calls will be relatively brief (maximum of 20-30 minutes).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Month" Item at 24 Weeks
Time Frame: Baseline and 24 weeks
The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month.
Baseline and 24 weeks
Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Week" Item at 24 Weeks
Time Frame: Baseline and 24 weeks
The TRQ "past week" item is a subject report of the percentage of prescribed medications not taken within the past week.
Baseline and 24 weeks
Change From Baseline in Treatment Adherence as Measured by Special Pill Counter at 24 Weeks
Time Frame: Baseline and 24 weeks
A special pill cap/box will record the time/date of bottle opening. A dose will be counted as "taken" if the bottle is opened within two hours of the prescribed time. A percent of doses taken (treatment adherence) will be calculated by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.
Baseline and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Case Western Reserve University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martha Sajatovic, MD, Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34MH117206 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data entered into the NIMH National Database: We will collaborate with our project office to determine the best mechanism to ensure that our Phase 3 data is entered into the common informatics platform by NIMH, called the National Database for Clinical Trials Related to Mental Illness (http://ndct.nimh.nih.gov, NDCT). We will work with NIMH to transform the data we collect into relevant information using the suggested consent form language, NIMH software that will create global unique identifiers and a useful data dictionary as much as we are able in order to deposit data into the National Database allowing other researchers and NIMH to use available data.

In line with accepted data sharing practices and ethical principles, we will share de-identified raw data with other researchers attempting to replicate our findings or including our findings in subsequent projects.

IPD Sharing Time Frame

One year after the final results have been published.

IPD Sharing Access Criteria

Researchers will be able to contact us by telephone or email to request these data, which we will provide in a timely manner. We will not release any data that are considered identifying or protected by IRB, HIPAA, or federal regulations unless that researcher and the PI of the current project have obtained proper administrative agreements or participation in the NIMH national database.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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