Bipolar DisorderIGNITENCT04348604
Improving Adherence in Adolescents and Young Adults With Bipolar Disorder
A study testing Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA) and Enhanced Treatment as Usual (ETAU) in people with Bipolar Disorder, run by Case Western Reserve University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA) and Enhanced Treatment as Usual (ETAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Mar 2021to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Cincinnati
Cincinnati, Ohio, 45219
Case Western Reserve Universty
Cleveland, Ohio, 44106
About this study
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
- Bipolar Disorder
- Being tested
- Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA), Enhanced Treatment as Usual (ETAU)
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA)Behavioural
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.
Enhanced Treatment as Usual (ETAU)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Customized Adherence Enhancement for AYA | Experimental | This arm will receive the experimental intervention, Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA). Receives: Behavioral: Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA) |
| Enhanced Treatment as Usual (ETAU) | Active comparator | This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU). Receives: Behavioral: Enhanced Treatment as Usual (ETAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Month" Item at 24 Weeks
The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month.
Measured: Baseline and 24 weeks
Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Week" Item at 24 Weeks
The TRQ "past week" item is a subject report of the percentage of prescribed medications not taken within the past week.
Measured: Baseline and 24 weeks
Change From Baseline in Treatment Adherence as Measured by Special Pill Counter at 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.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start15 Mar 2021
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Sajatovic, MD, Case Western Reserve University
- Investigators
- Martha Sajatovic, MD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348604
- Sponsor's protocol ID
- R34MH117206
- Acronym
- IGNITE
- Status last verified
- May 2026
- First submitted
- 14 Apr 2020
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Levin JB, DelBello M, Modi AC, Briggs F, Forthun LF, McVoy M, Yala J, Cooley R, Black J, Conroy C, Sajatovic M. A 6-month, prospective, randomized controlled trial of customized adherence enhancement versus a bipolar-specific educational control in poorly adherent adolescents and young adults living with bipolar disorder. Bipolar Disord. 2024 Nov;26(7):696-707. doi: 10.1111/bdi.13489. Epub 2024 Sep 4.
PubMed 39231780
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence in Adolescents and Young Adults With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT04348604
- Acronym / sponsor ID
- IGNITE / R34MH117206
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Customized Adherence Enhancement for AYA | Experimental | Behavioral: Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA)This arm will receive the experimental intervention, Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA). |
| Enhanced Treatment as Usual (ETAU) | Active comparator | Behavioral: Enhanced Treatment as Usual (ETAU)This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU). |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Customized Adherence Enhancement for AYA |
| 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). | Behavioural | Enhanced Treatment as Usual (ETAU) |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39231780Levin JB, DelBello M, Modi AC, Briggs F, Forthun LF, McVoy M, Yala J, Cooley R, Black J, Conroy C, Sajatovic M. A 6-month, prospective, randomized controlled trial of customized adherence enhancement versus a bipolar-specific educational control in poorly adherent adolescents and young adults living with bipolar disorder. Bipolar Disord. 2024 Nov;26(7):696-707. doi: 10.1111/bdi.13489. Epub 2024 Sep 4.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Sajatovic, MD principal investigator
Case Western Reserve University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA) and Enhanced Treatment as Usual (ETAU) in people with Bipolar Disorder, run by Case Western Reserve University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Month" Item at 24 Weeks (time frame: Baseline and 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04348604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.