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Measurement-Based Care for Bipolar Disorder
N/A
Waitlist Available
Led By Joseph Cerimele, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Elevated symptoms of bipolar disorder based on classification by the Internal State Scale (ISS) as depressed, mixed manic-depressive, or (hypo)manic state
Clinician diagnosis of bipolar disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will compare the effectiveness of measurement-based care to enhanced usual care in people with bipolar disorder. The main hypothesis is that treatment adjustments will occur more often in the MBC group than the enhanced usual care group. The exploratory hypothesis is that symptoms of bipolar disorder will decrease more in the MBC group than the enhanced usual care group.
Who is the study for?
This trial is for individuals with bipolar disorder who show elevated symptoms, are receiving care in the same primary care clinic, have a clinician's diagnosis of bipolar disorder, and are either newly referred to mental health clinicians or have recently changed their medication. It's not for those unable to consent to research or not planning on returning for follow-up.Check my eligibility
What is being tested?
The study is testing if measurement-based care (MBC), which involves regular assessments to guide treatment decisions, is more effective than enhanced usual care at managing bipolar disorder. Participants will be randomly assigned to one of these two approaches.See study design
What are the potential side effects?
Since this trial focuses on measuring clinical status and adjusting treatments accordingly rather than testing new medications, specific side effects aren't listed. However, changes in treatment could potentially lead to typical medication-related side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with bipolar disorder and am currently experiencing severe symptoms.
Select...
I have been diagnosed with bipolar disorder by a doctor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment changes
Secondary outcome measures
Additional instrument 1
Additional instrument 2
Additional instrument 3
+2 moreOther outcome measures
Exploratory
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MBC for depressive and manic symptomsExperimental Treatment1 Intervention
Measurement-based care (MBC) is a clinical strategy involving consistent assessment of clinical status and using those findings to drive clinical decision making. MBC involves clinic staff providing the measure to the patient at each visit which the patient completes and returns, staff enters results into the electronic medical record, clinician reviews current results and compares to past results, and discusses with the patient.
The experimental condition patients will receive MBC for manic and depressive symptoms.
Group II: MBC for depressive symptoms onlyActive Control1 Intervention
The active comparator arm patients will receive MBC for depressive symptoms.
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,321 Total Patients Enrolled
9 Trials studying Bipolar Disorder
2,344 Patients Enrolled for Bipolar Disorder
Mayo ClinicOTHER
3,205 Previous Clinical Trials
3,766,754 Total Patients Enrolled
9 Trials studying Bipolar Disorder
275 Patients Enrolled for Bipolar Disorder
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,689,077 Total Patients Enrolled
145 Trials studying Bipolar Disorder
63,555 Patients Enrolled for Bipolar Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with bipolar disorder and am currently experiencing severe symptoms.I've recently seen a mental health professional or changed my bipolar disorder medication.I have been diagnosed with bipolar disorder by a doctor.I do not plan to return to the same primary care clinic for follow-up.I am unable to give consent for research participation.
Research Study Groups:
This trial has the following groups:- Group 1: MBC for depressive and manic symptoms
- Group 2: MBC for depressive symptoms only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for individuals to enroll in this research study right now?
"According to clinicaltrials.gov, this particular trial is not actively seeking candidates at the moment. The study was published on June 1st 2023 and last updated over a year ago on April 28th 2022; nevertheless, there are still 154 other studies recruiting patients as we speak."
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