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Customized Adherence Enhancement for Bipolar Disorder (CAE-E Trial)
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.
CAE-E Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCAE-E Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 30 Patients • NCT03408873CAE-E Trial Design
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Who is running the clinical trial?
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- I often miss taking my bipolar disorder medication.I own a cell phone capable of receiving text messages.I have been diagnosed with Bipolar Disorder Type I or II.I am under 18 years old.I have been on mood-stabilizing medication for at least 6 months.You have a high risk of suicide and cannot be safely treated where you currently receive care.You have been diagnosed with bipolar disorder for at least two years.
- Group 1: Customized Adherence Enhancement (CAE)
- Group 2: Enhanced Treatment as Usual (eTAU)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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"
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."
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."
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