NCT05300919Completed
Bipolar Disorder Measures in Clinical Care
Source: ClinicalTrials.gov · Last updated 27 Apr 2025
Brief summary (registry, in English)
Measurement based care (MBC) is an emerging best practice involving serial assessment of clinical status and using those findings to inform clinical decision making. However, there is a lack of research on how to best apply principles of MBC for patients with bipolar disorder. The proposed project goal is to assess the feasibility of comparing effectiveness of measurement-based care (MBC) to enhanced usual care in a randomized trial. Many individuals with bipolar disorder experience fluctuating depressive and manic symptoms which can impair functioning and reduce quality of life. 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 9 Mar 2022
- Start date
- 1 Nov 2023
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- University of Cincinnati
- Diseases
- Bipolar disorder
- NCT number
- NCT05300919
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 1 Nov 2023 to the primary completion date, 30 Nov 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Inability to consent to participation in research, not planning to return for follow-up in the same primary care clinic
Who the study is looking for
- clinician diagnosis of bipolar disorder, and elevated symptoms of bipolar disorder based on classification by the Internal State Scale (ISS) as depressed, mixed manic-depressive, or (hypo)manic state, planned continued care in the same primary care clinic, and either a new consultation by or referral to the integrated behavioral health (IBH) mental health clinicians, or a recent change in bipolar disorder medication treatment,
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.