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

Completed

• Conditions: Bipolar I Disorder

• Registration Number: NCT05956483
• Lead Sponsor: AbbVie

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-21
• Study Start: 2023-12-04
• Status Verified: 2024-08
• Primary Completion: 2024-08-16
• Study Completion: 2024-08-16
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 423

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of Rapid Mood Screener (RMS)	Day 1	Sensitivity is defined as TP/(TP+FN).
Positive Predictive Value (PPV) of Rapid Mood Screener (RMS)	Day 1	PPV is defined as True Positive(TP)/(TP + False Positive (FP)).
Negative Predictive Value (NPV) of Rapid Mood Screener (RMS)	Day 1	NPV is defined as True Negative(TN)/(TN + False Negative (FN)).
Specificity of Rapid Mood Screener (RMS)	Day 1	Specificity is defined as TN/(TN+FP).

Trial Locations

Locations (9)

Richard Louis Price, M.D., LLC /ID# 253527; 🇺🇸 Monsey, New York, United States

Health Synergy Clinical Research LLC /ID# 262998; 🇺🇸 Okeechobee, Florida, United States

ATP Clinical Research, Inc /ID# 255223; 🇺🇸 Costa Mesa, California, United States

CT Clinical Research /ID# 253488; 🇺🇸 Cromwell, Connecticut, United States

UHC Research /ID# 263151; 🇺🇸 Doral, Florida, United States

J&A Clinical Research /ID# 263034; 🇺🇸 Doral, Florida, United States

Interventional Psychiatry of Tampa Bay /ID# 253526; 🇺🇸 Tampa, Florida, United States

Oceanic Research Group /ID# 263032; 🇺🇸 North Miami Beach, Florida, United States

MedOne Clinical Research /ID# 263031; 🇺🇸 Miami, Florida, United States