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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
Must not have
Not planning to return for follow-up in the same primary care clinic
Inability to consent to participation in research
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

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 below
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I have been diagnosed with bipolar disorder and am currently experiencing severe symptoms.
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I have been diagnosed with bipolar disorder by a doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not plan to return to the same primary care clinic for follow-up.
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I am unable to give consent for research participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Treatment changes
Secondary outcome measures
Additional instrument 1
Additional instrument 2
Additional instrument 3
+2 more
Other 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
1,762 Previous Clinical Trials
1,876,452 Total Patients Enrolled
9 Trials studying Bipolar Disorder
2,344 Patients Enrolled for Bipolar Disorder
Mayo ClinicOTHER
3,255 Previous Clinical Trials
3,835,376 Total Patients Enrolled
9 Trials studying Bipolar Disorder
275 Patients Enrolled for Bipolar Disorder
National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,789 Total Patients Enrolled
146 Trials studying Bipolar Disorder
64,055 Patients Enrolled for Bipolar Disorder

Media Library

Measurement based care Clinical Trial Eligibility Overview. Trial Name: NCT05300919 — N/A
Bipolar Disorder Research Study Groups: MBC for depressive and manic symptoms, MBC for depressive symptoms only
Bipolar Disorder Clinical Trial 2023: Measurement based care Highlights & Side Effects. Trial Name: NCT05300919 — N/A
Measurement based care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05300919 — N/A
~2 spots leftby Sep 2024
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