Study to Assess Accuracy of Rapid Mood Screener in Adult Participants With Unipolar Major Depressive Disorder or Bipolar 1 Disorder in Real World Setting

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bipolar I Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rapid Mood Screener (RMS)<br>Participants with Unipolar Major Depressive Disorder and Bipolar 1 Depression will be evaluated with RMS questionnaire and MINI interview. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Predictive Value (PPV) of Rapid Mood Screener (RMS) | PPV is defined as True Positive(TP)/(TP + False Positive (FP)). | Day 1 | 
| Negative Predictive Value (NPV) of Rapid Mood Screener (RMS) | NPV is defined as True Negative(TN)/(TN + False Negative (FN)). | Day 1 | 
| Sensitivity of Rapid Mood Screener (RMS) | Sensitivity is defined as TP/(TP+FN). | Day 1 | 
| Specificity of Rapid Mood Screener (RMS) | Specificity is defined as TN/(TN+FP). | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar I Disorder (BP1), Unipolar major depressive disorder (MDD), Rapid Mood Screener (RMS)