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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid Mood Screener (RMS) | Participants with Unipolar Major Depressive Disorder and Bipolar 1 Depression will be evaluated with RMS questionnaire and MINI interview. |
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| 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 |
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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:
Exclusion Criteria:
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Adult participants with Bipolar 1 Disorder or Unipolar Major Depressive Disorder
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATP Clinical Research, Inc /ID# 255223 | Costa Mesa | California | 92626-4607 | United States | ||
| CT Clinical Research /ID# 253488 |
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| Cromwell |
| Connecticut |
| 06416 |
| United States |
| UHC Research /ID# 263151 | Doral | Florida | 33126-1829 | United States |
| J&A Clinical Research /ID# 263034 | Doral | Florida | 33126-1834 | United States |
| MedOne Clinical Research /ID# 263031 | Miami | Florida | 33145 | United States |
| Oceanic Research Group /ID# 263032 | North Miami Beach | Florida | 33169-5510 | United States |
| Health Synergy Clinical Research LLC /ID# 262998 | Okeechobee | Florida | 34972-2568 | United States |
| Interventional Psychiatry of Tampa Bay /ID# 253526 | Tampa | Florida | 33629-5837 | United States |
| Richard Louis Price, M.D., LLC /ID# 253527 | Monsey | New York | 10952-1233 | United States |