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Customized Adherence Enhancement for Bipolar Disorder (CAE-E Trial)

N/A
Recruiting
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
20% or more non-adherent with current BD medication treatment (i.e. lithium, anticonvulsant, or antipsychotic mood stabilizer)
Have their own cellular phone in order to receive text messages as part of the intervention
Must not have
Children under the age of 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether a technology-facilitated Customized Adherence Enhancement (CAE) can improve outcomes for people with bipolar disorder who are at high risk for poor adherence.

Who is the study for?
This trial is for adults with Bipolar Disorder who struggle to stick to their medication regimen. They must have been treated with mood stabilizers like lithium or antipsychotics for at least six months, own a cell phone, and be able to give consent. It's not for those under 18, unable to consent or participate in interviews due to severe psychiatric symptoms, previous Phase 1 participants, or individuals at high suicide risk.
What is being tested?
The study compares two methods: Customized Adherence Enhancement (CAE), which uses technology and a curriculum-based approach; versus Enhanced Treatment as Usual (eTAU) in public mental health settings. The goal is to see if CAE can better help people with Bipolar Disorder follow their medication plans.
What are the potential side effects?
Since this trial focuses on adherence rather than new medications, side effects are related more to the intervention method itself rather than drug reactions. Participants may experience discomfort from increased monitoring of medication habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I often miss taking my bipolar disorder medication.
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I own a cell phone capable of receiving text messages.
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I have been diagnosed with Bipolar Disorder Type I or II.
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I have been on mood-stabilizing medication for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in the Tablet Routine Questionaire (TRQ) "past month" item at 12 months
Change from baseline in the Tablet Routine Questionaire (TRQ) "past week" item at 12 months
Change from baseline in treatment adherence as measured by electronic pill monitoring (eCAPS) at 12 months
Secondary study objectives
change in Brief Psychiatric Rating Scale (BPRS)
change in Clinical Global Impressions Scale (CGI)
change in Global Assessment of Functioning (GAF)
+2 more

Side effects data

From 2020 Phase 4 trial • 30 Patients • NCT03408873
30%
Drowsiness
30%
Injection site pain or reaction
26%
Tremor
13%
Sexual dysfunction
9%
Drooling
9%
Muscle Movement complaints
9%
Weight gain
100%
80%
60%
40%
20%
0%
Study treatment Arm
CAE-L

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Customized Adherence Enhancement (CAE)Experimental Treatment1 Intervention
This arm will receive the experimental intervention, Customized Adherence Enhancement (CAE).
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 (CAE)
2012
Completed Phase 4
~220

Find a Location

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor
306 Previous Clinical Trials
247,226 Total Patients Enrolled
12 Trials studying Bipolar Disorder
1,017 Patients Enrolled for Bipolar Disorder
National Institute of Mental Health (NIMH)NIH
2,897 Previous Clinical Trials
2,732,496 Total Patients Enrolled
146 Trials studying Bipolar Disorder
63,895 Patients Enrolled for Bipolar Disorder
Martha Sajatovic, MDPrincipal InvestigatorCase Western Reserve University
20 Previous Clinical Trials
1,376 Total Patients Enrolled
11 Trials studying Bipolar Disorder
687 Patients Enrolled for Bipolar Disorder

Media Library

Customized Adherence Enhancement (CAE) Clinical Trial Eligibility Overview. Trial Name: NCT04622150 — N/A
Bipolar Disorder Research Study Groups: Enhanced Treatment as Usual (eTAU), Customized Adherence Enhancement (CAE)
Bipolar Disorder Clinical Trial 2023: Customized Adherence Enhancement (CAE) Highlights & Side Effects. Trial Name: NCT04622150 — N/A
Customized Adherence Enhancement (CAE) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04622150 — N/A
~51 spots leftby Nov 2025
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