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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights

CAE-E Trial 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.Check my eligibility
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.See study design
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.

CAE-E Trial 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.

CAE-E Trial 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

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 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 outcome measures
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

CAE-E 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
299 Previous Clinical Trials
259,904 Total Patients Enrolled
12 Trials studying Bipolar Disorder
1,017 Patients Enrolled for Bipolar Disorder
National Institute of Mental Health (NIMH)NIH
2,777 Previous Clinical Trials
2,674,182 Total Patients Enrolled
145 Trials studying Bipolar Disorder
63,395 Patients Enrolled for Bipolar Disorder
Martha Sajatovic, MDPrincipal InvestigatorCase Western Reserve University
19 Previous Clinical Trials
1,333 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: Customized Adherence Enhancement (CAE), Enhanced Treatment as Usual (eTAU)
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

Frequently Asked Questions

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

What is the ultimate goal of this research endeavor?

"This medical study seeks to measure the alteration in adherence at 12 months using electronic pill monitoring (eCAPS) as its primary outcome. The secondary outcomes revolve around changes in Young Mania Rating Scale, Global Assessment of Functioning and Clinical Global Impressions Scale, which are all rated on a 1-7 or 0-60 numerical scale respectively with higher numbers representing worse conditions."

Answered by AI

Could you provide an estimate of the total number of people participating in this research project?

"Affirmative. Per the clinicaltrials.gov website, this research is actively trying to recruit participants. It was first launched on February 1st 2022 and modified as of September 14th 2022. The study seeks 190 individuals at 2 sites for inclusion."

Answered by AI

Am I a viable candidate to be part of this research endeavor?

"This trial intends to recruit 190 people diagnosed with manic disorder, aged 18-89. To be considered an eligible candidate they must receive care from the Nord Center or MetroHealth system, have had BD for 2+ years and received evidence-based medication treatment to stabilise moods for 6 months (lithium, anticonvulsant or antipsychotic). Additionally their BPRS score should be ≥36; YRMS ≥8; MADRS ≥8 and a diagnosis of Bipolar disorder Type I/II via SCID-P is also required. Furthermore 20% nonadherence with current BD medication treatment is essential as"

Answered by AI

Are there any opportunities for recruitment into this study at present?

"Right. Clinicaltrials.gov records indicate that this trial, which was initially unveiled on February 1st 2022, is currently recruiting its cohort of 190 volunteers from 2 distinct medical centres."

Answered by AI

Is the age range for this investigation limited to individuals over 35?

"This specific trial is only open to individuals aged 18-89. There are 21 trials recruiting younger patients and 114 targeting those over 65 years old."

Answered by AI
~80 spots leftby Nov 2025