Bipolar I DisorderNCT05956483
Study to Assess Accuracy of Rapid Mood Screener in Adult Participants With Unipolar Major Depressive Disorder or Bipolar 1 Disorder in Real World Setting
An observational study of Bipolar I Disorder, run by AbbVie at 9 sites in United States.
Trial summary
Bipolar I Disorder (BP1)is a severe chronic mood disorder characterized by manic and depression. BP1 has high probability of being misunderstood as unipolar major depressive disorder (MDD). The purpose of this study is to confirm Rapid Mood Screener (RMS) effectively classifies participants with BP1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar I Disorder
- How many people
- 423 participants
- Where
- 9 sitesUnited States
- Study dates
- 4 Dec 2023to 16 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with Bipolar 1 Disorder or Unipolar Major Depressive Disorder
Who may be able to join
- Presenting to provider with primary complaint of new or continuing depressive symptoms.
- May be treatment naïve even if not in their first depressive episode.
- Meets one of the following criteria:
- Previously treated and currently off medication.
- Currently using an antidepressant, atypical antipsychotic for mood disorder, or mood stabilizer.
Who cannot join
- Hospitalized or admitted to the emergency room due to mental health issues in the past 30 days.
- Currently experiencing a manic episode.
- History of schizophrenia or depression due to another psychotic disorder or a medical, organic, or drug-induced cause or a neurocognitive disorder (dementia/delirium) (as defined by Diagnostic and Statistical Manual of Mental Disorders [DSM-V] criteria).
- Participant did not provide informed consent.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
ATP Clinical Research, Inc /ID# 255223
Costa Mesa, California, 92626-4607
CT Clinical Research /ID# 253488
Cromwell, Connecticut, 06416
UHC Research /ID# 263151
Doral, Florida, 33126-1829
J&A Clinical Research /ID# 263034
Doral, Florida, 33126-1834
MedOne Clinical Research /ID# 263031
Miami, Florida, 33145
Richard Louis Price, M.D., LLC /ID# 253527
Monsey, New York, 10952-1233
Oceanic Research Group /ID# 263032
North Miami Beach, Florida, 33169-5510
Health Synergy Clinical Research LLC /ID# 262998
Okeechobee, Florida, 34972-2568
Interventional Psychiatry of Tampa Bay /ID# 253526
Tampa, Florida, 33629-5837
About this study
Official title: A Confirmatory Study of the Rapid Mood Screener for Bipolar 1 Disorder to Evaluate Capability to Distinguish Between Subjects With Unipolar Major Depressive Disorder and Bipolar 1 in a Real-world Setting
Bipolar I Disorder (BP1)is a severe chronic mood disorder characterized by manic and depression. BP1 has high probability of being misunderstood as unipolar major depressive disorder (MDD). The purpose of this study is to confirm Rapid Mood Screener (RMS) effectively classifies participants with BP1.
Rapid Mood Screener (RMS) is a brief 6-item clinician-administered checklist, in which a participant's endorsement of four or more questions should trigger further clinical evaluation for BP1. Approximately 404 participants (303 with confirmed unipolar MDD and 101 with confirmed BP1) will be enrolled in the United States.
Participants will be answering RMS questionnaire and accuracy will be measured against Mini-International Neuropsychiatric Interview (MINI) interview.
- Conditions
- Bipolar I Disorder
- Keywords
- Bipolar I Disorder (BP1), Unipolar major depressive disorder (MDD), Rapid Mood Screener (RMS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rapid Mood Screener (RMS) | Participants with Unipolar Major Depressive Disorder and Bipolar 1 Depression will be evaluated with RMS questionnaire and MINI interview. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value (PPV) of Rapid Mood Screener (RMS)
PPV is defined as True Positive(TP)/(TP + False Positive (FP)).
Measured: Day 1
Negative Predictive Value (NPV) of Rapid Mood Screener (RMS)
NPV is defined as True Negative(TN)/(TN + False Negative (FN)).
Measured: Day 1
Sensitivity of Rapid Mood Screener (RMS)
Sensitivity is defined as TP/(TP+FN).
Measured: Day 1
Specificity of Rapid Mood Screener (RMS)
Specificity is defined as TN/(TN+FP).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start4 Dec 2023
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956483
- Sponsor's protocol ID
- H23-890
- Status last verified
- Aug 2024
- First submitted
- 14 Jul 2023
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory Study of the Rapid Mood Screener for Bipolar 1 Disorder to Evaluate Capability to Distinguish Between Subjects With Unipolar Major Depressive Disorder and Bipolar 1 in a Real-world Setting
- ClinicalTrials.gov ID
- NCT05956483
- Acronym / sponsor ID
- H23-890
- Conditions
- Bipolar I Disorder
- Keywords
- Bipolar I Disorder (BP1), Unipolar major depressive disorder (MDD), Rapid Mood Screener (RMS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bipolar I Disorder (BP1)is a severe chronic mood disorder characterized by manic and depression. BP1 has high probability of being misunderstood as unipolar major depressive disorder (MDD). The purpose of this study is to confirm Rapid Mood Screener (RMS) effectively classifies participants with BP1.
Rapid Mood Screener (RMS) is a brief 6-item clinician-administered checklist, in which a participant's endorsement of four or more questions should trigger further clinical evaluation for BP1. Approximately 404 participants (303 with confirmed unipolar MDD and 101 with confirmed BP1) will be enrolled in the United States.
Participants will be answering RMS questionnaire and accuracy will be measured against Mini-International Neuropsychiatric Interview (MINI) interview.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapid Mood Screener (RMS) | – | –Participants with Unipolar Major Depressive Disorder and Bipolar 1 Depression will be evaluated with RMS questionnaire and MINI interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with Bipolar 1 Disorder or Unipolar Major Depressive Disorder
Key inclusion criteria (5 listed)
- Presenting to provider with primary complaint of new or continuing depressive symptoms.
- May be treatment naïve even if not in their first depressive episode.
- Meets one of the following criteria:
Key exclusion criteria (4 listed)
- Hospitalized or admitted to the emergency room due to mental health issues in the past 30 days.
- Currently experiencing a manic episode.
- History of schizophrenia or depression due to another psychotic disorder or a medical, organic, or drug-induced cause or a neurocognitive disorder (dementia/delirium) (as defined by Diagnostic and Statistical Manual of Mental Disorders [DSM-V] criteria).
- Participant did not provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive Predictive Value (PPV) of Rapid Mood Screener (RMS)
Time frame: Day 1
PPV is defined as True Positive(TP)/(TP + False Positive (FP)).
Negative Predictive Value (NPV) of Rapid Mood Screener (RMS)
Time frame: Day 1
NPV is defined as True Negative(TN)/(TN + False Negative (FN)).
Sensitivity of Rapid Mood Screener (RMS)
Time frame: Day 1
Sensitivity is defined as TP/(TP+FN).
Specificity of Rapid Mood Screener (RMS)
Time frame: Day 1
Specificity is defined as TN/(TN+FP).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar I Disorder, run by AbbVie at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value (PPV) of Rapid Mood Screener (RMS) (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.