Bipolar DisorderCAE-ENCT04622150
Effectiveness RCT of Customized Adherence Enhancement
A study testing Customized Adherence Enhancement (CAE) and Enhanced Treatment as Usual (eTAU) in people with Bipolar Disorder, run by Case Western Reserve University at 3 sites in United States.
Trial summary
Approximately one in two individuals with bipolar disorder (BD) are non-adherent with medication, often leading to severe and negative consequences. Unfortunately, there is no widely used evidence-based approach to target poor adherence among individuals with BD. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Customized Adherence Enhancement (CAE) 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
- 190 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2022to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will have a diagnosis of Bipolar Disorder Type I or Type II determined by the Structured Clinical Interview for DSM-5 patient version (SCID-P).
- Have had BD for at least two years duration
- Have received treatment with at least one evidence-based medication to stabilize mood for at least six months (lithium, anticonvulsant, or antipsychotic mood stabilizer)
- Yes to either of the following questions:
- Do you ever have any trouble taking all of your medications? Or
- Do you ever try to cope on your own without medication?
Show all 9Show fewer
- a BPRS ≥ 36 or YRMS ≥8 or MADRS ≥8
- Be able to participate in psychiatric interviews and give written informed consent
- Have their own cellular phone in order to receive text messages as part of the intervention
Who cannot join
- Unable or unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales
- Unable or unwilling to give written, informed consent to study participation
- Individuals who participated in Phase 1 of the study
- Children under the age of 18
- Individuals at high risk for suicide who cannot be safely managed in their current treatment setting
Trial locations and contacts
3 sites in 1 country.
United States3 sites
W.O. Walker Center
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
The Nord Center
Lorain, Ohio, 44053
About this study
Approximately one in two individuals with bipolar disorder (BD) are non-adherent with medication, often leading to severe and negative consequences. Unfortunately, there is no widely used evidence-based approach to target poor adherence among individuals with BD. Building upon positive efficacy trial results, the proposed project will test the effectiveness of technology-facilitated Customized Adherence Enhancement (CAE) vs. enhanced treatment as usual (eTAU) using a prospective randomized controlled design in public mental health care settings and preferentially enrolling poorly adherent/high-risk individuals with BD. Deliverables include a curriculum-driven adherence enhancement approach that can be implemented in public healthcare settings and which can improve outcomes for the most vulnerable groups of people with BD.
Read the detailed description
A cornerstone of treatment uniformly recommended for individuals with bipolar disorder (BD) is mood stabilizing medication. However, approximately one in two individuals with BD are non-adherent with medication, often leading to severe and negative consequences. Unfortunately, there is no widely used evidence-based approach to target poor adherence in BD.
Customized Adherence Enhancement (CAE), developed by this study team, is a brief, practical BD-specific approach that identifies individual adherence barriers and then targets these areas for intervention using a flexibly-administered modular format. A prospective, 6-month, randomized controlled efficacy trial (RCT) of CAE vs. a rigorous control, BD-specific education (EDU) found that medication adherence and functional status were improved in CAE vs. EDU for poorly-adherent patients. Remarkably, the benefits of CAE occurred in individuals who had been living with BD, on average, for over 2 decades. While promising, the original efficacy RCT was limited by the fact that it was performed in an academic medical center, did not make use of existing web/text messaging technology, and did not address potential challenges to scale-up in standard clinical settings.
In response to PA-18-722 "Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health", this Type 1 hybrid effectiveness-implementation project will adapt CAE for use in community/public-sector care settings, test effectiveness in high-risk, poorly adherent individuals in these settings, and gather evidence on barriers and facilitators to implementation of the intervention in order to inform subsequent scale-up. The project will examine putative mechanistic engagement targets suggested by previous work and include implementation elements that will inform future dissemination should findings be positive. The project will be implemented in 4 specific aims: 1) Refine the CAE intervention guided by stakeholders at a community mental health clinic (CMHC) and a safety-net county healthcare system, 2) Test the effectiveness of technology-facilitated CAE vs. enhanced treatment as usual (eTAU) using a prospective, 2-site RCT, 3) Test the effects of CAE vs. eTAU on functional status in poorly adherent individuals with BD, and 4) Identify barriers and facilitators to CAE implementation in order to inform subsequent scale-up and spread using qualitative methods and guided by implementation conceptual models. Additional exploratory analysis will assess whether changes in patient-level adherence barriers and facilitators mediate the treatment effects on adherence. Finally, the project will evaluate on-site (outpatient visits, no-show rates) and off-site (emergency department visits, hospitalizations) health resource use to help characterize relative value and inform future sustainability efforts. An over-arching goal of this project will be to provide a curriculum-driven adherence enhancement approach that can be implemented in public-sector care settings and which can improve outcomes for the most vulnerable groups of people with BD.
- Conditions
- Bipolar Disorder
- Being tested
- Customized Adherence Enhancement (CAE), 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 (CAE)Behavioural
CAE is comprised of a series of up to four treatment modules whose inclusion is determined based upon an individuals reasons for nonadherence (adherence barriers).The standardized modules are Psychoeducation, Modified Motivational Interviewing, Communication with Providers, Medication Routines. CAE participants will have a core series of approximately four sessions spaced about one week apart over a period of 4-6 weeks, and one booster in-person session 4 weeks after the completion of the four core sessions (total of approximately 5 sessions). Sessions 2-4 will be delivered remotely by the study interventionist. All participants will have the first session in-person. The final booster session will be conducted at the sites and will review all previously introduced materials. There will be a follow-up phone call with the study interventionist that will occur in the four-week time period between completion of four CAE core sessions and prior to initiation of the booster CAE session.
Enhanced Treatment as Usual (eTAU)Behavioural
eTAU participants will receive monthly text messages (or phone calls for participants who prefer not to receive texts) to refill medications, fill eCAPs and brief general adherence promotion messages during the follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Customized Adherence Enhancement (CAE) | Experimental | This arm will receive the experimental intervention, Customized Adherence Enhancement (CAE). Receives: Behavioral: Customized Adherence Enhancement (CAE) |
| 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 week" item at 6 months
The TRQ "past week" item is a subject report of the percentage of prescribed medications not taken within the past week. The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Measured: Baseline and 6 Months; extension phase will be Baseline up to 12 months
Change from baseline in the Tablet Routine Questionaire (TRQ) "past month" item at 6 months
The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month. The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Measured: Baseline and 6 Months; extension phase will be Baseline up to 12 months
Change from baseline in treatment adherence as measured by electronic pill monitoring (eCAPS) at 6 months
A special pill cap (eCAPS) will record bottle openings. Adherence is defined as the percentage of pills missed, with a higher value indicating poorer adherence.
Measured: Baseline and 6 Months; extension phase will be Baseline up to 12 months
Secondary outcomes (5)
change in Global Assessment of Functioning (GAF)
The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.
Measured: Baseline and 6 Months; extension phase will be Baseline up to 12 months
change in Brief Psychiatric Rating Scale (BPRS)
The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.
Measured: Baseline and 6 Months; extension phase will be Baseline up to 12 months
change in Young Mania Rating Scale (YMRS)
The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Measured: Baseline and 6 Months; extension phase will be Baseline up to 12 months
change in Montgomery Asberg Depression Rating Scale (MADRS)
The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Measured: Baseline and 6 Months; extension phase will be Baseline up to 12 months
change in Clinical Global Impressions Scale (CGI)
The minimum possible score is 1 and the maximum score is 7. A higher scores implies a worse condition.
Measured: Baseline and 6 Months; extension phase will be Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Feb 2022
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- 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
- NCT04622150
- Sponsor's protocol ID
- STUDY20210857
- Other IDs
- R01MH119487
- Acronym
- CAE-E
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2020
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will collaborate with our project office to determine the best mechanism to ensure that our study 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
Sajatovic M, Levin JB, Adeniyi C, Black J, Weise C, Fiorelli N, Kelley E, Einstadter D, Bauer M, Briggs FBS. Association Between Adherence Barriers, Self-Reported Adherence, and Psychiatric Symptoms Among Adults With Bipolar Disorder. Bipolar Disord. 2025 Dec;27(8):567-577. doi: 10.1111/bdi.70067. Epub 2025 Nov 11.
PubMed 41220091Sajatovic M, Briggs F, Adeniyi C, Koopman J, Black J, Weise C, Fiorelli N, Yala J, Lesanpezeshki M, Einstadter D, Levin JB. Association Between Symptom Severity and Medication Adherence in Adults with Bipolar Disorder Reporting Adherence Challenges. Psychopharmacol Bull. 2024 Jul 8;54(3):60-72. doi: 10.64719/pb.4494.
PubMed 38993661Levin JB, Briggs F, Blixen C, Bauer M, Einstadter D, Albert JM, Weise C, Woods N, Fuentes-Casiano E, Cassidy KA, Rentsch J, Sarna K, Sajatovic M. A randomized controlled trial of customized adherence enhancement (CAE-E): study protocol for a hybrid effectiveness-implementation project. Trials. 2022 Aug 4;23(1):634. doi: 10.1186/s13063-022-06517-0.
PubMed 35927740
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness RCT of Customized Adherence Enhancement
- ClinicalTrials.gov ID
- NCT04622150
- Acronym / sponsor ID
- CAE-E / STUDY20210857
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately one in two individuals with bipolar disorder (BD) are non-adherent with medication, often leading to severe and negative consequences. Unfortunately, there is no widely used evidence-based approach to target poor adherence among individuals with BD. Building upon positive efficacy trial results, the proposed project will test the effectiveness of technology-facilitated Customized Adherence Enhancement (CAE) vs. enhanced treatment as usual (eTAU) using a prospective randomized controlled design in public mental health care settings and preferentially enrolling poorly adherent/high-risk individuals with BD. Deliverables include a curriculum-driven adherence enhancement approach that can be implemented in public healthcare settings and which can improve outcomes for the most vulnerable groups of people with BD.
Detailed description
A cornerstone of treatment uniformly recommended for individuals with bipolar disorder (BD) is mood stabilizing medication. However, approximately one in two individuals with BD are non-adherent with medication, often leading to severe and negative consequences. Unfortunately, there is no widely used evidence-based approach to target poor adherence in BD.
Customized Adherence Enhancement (CAE), developed by this study team, is a brief, practical BD-specific approach that identifies individual adherence barriers and then targets these areas for intervention using a flexibly-administered modular format. A prospective, 6-month, randomized controlled efficacy trial (RCT) of CAE vs. a rigorous control, BD-specific education (EDU) found that medication adherence and functional status were improved in CAE vs. EDU for poorly-adherent patients. Remarkably, the benefits of CAE occurred in individuals who had been living with BD, on average, for over 2 decades. While promising, the original efficacy RCT was limited by the fact that it was performed in an academic medical center, did not make use of existing web/text messaging technology, and did not address potential challenges to scale-up in standard clinical settings.
In response to PA-18-722 "Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health", this Type 1 hybrid effectiveness-implementation project will adapt CAE for use in community/public-sector care settings, test effectiveness in high-risk, poorly adherent individuals in these settings, and gather evidence on barriers and facilitators to implementation of the intervention in order to inform subsequent scale-up. The project will examine putative mechanistic engagement targets suggested by previous work and include implementation elements that will inform future dissemination should findings be positive. The project will be implemented in 4 specific aims: 1) Refine the CAE intervention guided by stakeholders at a community mental health clinic (CMHC) and a safety-net county healthcare system, 2) Test the effectiveness of technology-facilitated CAE vs. enhanced treatment as usual (eTAU) using a prospective, 2-site RCT, 3) Test the effects of CAE vs. eTAU on functional status in poorly adherent individuals with BD, and 4) Identify barriers and facilitators to CAE implementation in order to inform subsequent scale-up and spread using qualitative methods and guided by implementation conceptual models. Additional exploratory analysis will assess whether changes in patient-level adherence barriers and facilitators mediate the treatment effects on adherence. Finally, the project will evaluate on-site (outpatient visits, no-show rates) and off-site (emergency department visits, hospitalizations) health resource use to help characterize relative value and inform future sustainability efforts. An over-arching goal of this project will be to provide a curriculum-driven adherence enhancement approach that can be implemented in public-sector care settings and which can improve outcomes for the most vulnerable groups of people with BD.
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 (CAE) | Experimental | Behavioral: Customized Adherence Enhancement (CAE)This arm will receive the experimental intervention, Customized Adherence Enhancement (CAE). |
| 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
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants will have a diagnosis of Bipolar Disorder Type I or Type II determined by the Structured Clinical Interview for DSM-5 patient version (SCID-P).
- Have had BD for at least two years duration
- Have received treatment with at least one evidence-based medication to stabilize mood for at least six months (lithium, anticonvulsant, or antipsychotic mood stabilizer)
- Yes to either of the following questions:
- a BPRS ≥ 36 or YRMS ≥8 or MADRS ≥8
Key exclusion criteria (5 listed)
- Unable or unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales
- Unable or unwilling to give written, informed consent to study participation
- Individuals who participated in Phase 1 of the study
- Children under the age of 18
- Individuals at high risk for suicide who cannot be safely managed in their current treatment setting
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 (CAE)CAE is comprised of a series of up to four treatment modules whose inclusion is determined based upon an individuals reasons for nonadherence (adherence barriers).The standardized modules are Psychoeducation, Modified Motivational Interviewing, Communication with Providers, Medication Routines. CAE participants will have a core series of approximately four sessions spaced about one week apart over a period of 4-6 weeks, and one booster in-person session 4 weeks after the completion of the four core sessions (total of approximately 5 sessions). Sessions 2-4 will be delivered remotely by the study interventionist. All participants will have the first session in-person. The final booster session will be conducted at the sites and will review all previously introduced materials. There will be a follow-up phone call with the study interventionist that will occur in the four-week time period between completion of four CAE core sessions and prior to initiation of the booster CAE session. | Behavioural | Customized Adherence Enhancement (CAE) |
| Enhanced Treatment as Usual (eTAU)eTAU participants will receive monthly text messages (or phone calls for participants who prefer not to receive texts) to refill medications, fill eCAPs and brief general adherence promotion messages during the follow-up period. | Behavioural | Enhanced Treatment as Usual (eTAU) |
Primary outcome
Change from baseline in the Tablet Routine Questionaire (TRQ) "past week" item at 6 months
Time frame: Baseline and 6 Months; extension phase will be Baseline up to 12 months
The TRQ "past week" item is a subject report of the percentage of prescribed medications not taken within the past week. The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Change from baseline in the Tablet Routine Questionaire (TRQ) "past month" item at 6 months
Time frame: Baseline and 6 Months; extension phase will be Baseline up to 12 months
The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month. The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Change from baseline in treatment adherence as measured by electronic pill monitoring (eCAPS) at 6 months
Time frame: Baseline and 6 Months; extension phase will be Baseline up to 12 months
A special pill cap (eCAPS) will record bottle openings. Adherence is defined as the percentage of pills missed, with a higher value indicating poorer adherence.
5 secondary outcomes
change in Global Assessment of Functioning (GAF)
Time frame: Baseline and 6 Months; extension phase will be Baseline up to 12 months
change in Brief Psychiatric Rating Scale (BPRS)
Time frame: Baseline and 6 Months; extension phase will be Baseline up to 12 months
change in Young Mania Rating Scale (YMRS)
Time frame: Baseline and 6 Months; extension phase will be Baseline up to 12 months
change in Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Baseline and 6 Months; extension phase will be Baseline up to 12 months
change in Clinical Global Impressions Scale (CGI)
Time frame: Baseline and 6 Months; extension phase will be Baseline up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Derived from this study: PubMed 41220091Sajatovic M, Levin JB, Adeniyi C, Black J, Weise C, Fiorelli N, Kelley E, Einstadter D, Bauer M, Briggs FBS. Association Between Adherence Barriers, Self-Reported Adherence, and Psychiatric Symptoms Among Adults With Bipolar Disorder. Bipolar Disord. 2025 Dec;27(8):567-577. doi: 10.1111/bdi.70067. Epub 2025 Nov 11.
- Derived from this study: PubMed 38993661Sajatovic M, Briggs F, Adeniyi C, Koopman J, Black J, Weise C, Fiorelli N, Yala J, Lesanpezeshki M, Einstadter D, Levin JB. Association Between Symptom Severity and Medication Adherence in Adults with Bipolar Disorder Reporting Adherence Challenges. Psychopharmacol Bull. 2024 Jul 8;54(3):60-72. doi: 10.64719/pb.4494.
- Derived from this study: PubMed 35927740Levin JB, Briggs F, Blixen C, Bauer M, Einstadter D, Albert JM, Weise C, Woods N, Fuentes-Casiano E, Cassidy KA, Rentsch J, Sarna K, Sajatovic M. A randomized controlled trial of customized adherence enhancement (CAE-E): study protocol for a hybrid effectiveness-implementation project. Trials. 2022 Aug 4;23(1):634. doi: 10.1186/s13063-022-06517-0.
- Individual participant dataSharing planned: Yes. We will collaborate with our project office to determine the best mechanism to ensure that our study 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.
Related trials for Bipolar Disorder
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Mania, Bipolar Disorder
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
Bipolar Disorder, Major Depressive Disorder
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
3 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 (CAE) and Enhanced Treatment as Usual (eTAU) in people with Bipolar Disorder, run by Case Western Reserve University at 3 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 9 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 3 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 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 week" item at 6 months (time frame: Baseline and 6 Months; extension phase will be Baseline up to 12 months). 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 NCT04622150, which also lists 3 linked publications.
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 3 Jun 2026.