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

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.

Study Overview

• Status: Completed
• Conditions: Bipolar I Disorder

• Study Type: Observational
• Enrollment (Actual): 423

Contacts and Locations

Study Locations

• United States
  • California
    • Costa Mesa, California, United States, 92626-4607
      • ATP Clinical Research, Inc /ID# 255223
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • CT Clinical Research /ID# 253488
  • Florida
    • Doral, Florida, United States, 33126-1829
      • UHC Research /ID# 263151
    • Doral, Florida, United States, 33126-1834
      • J&A Clinical Research /ID# 263034
    • Miami, Florida, United States, 33145
      • MedOne Clinical Research /ID# 263031
    • North Miami Beach, Florida, United States, 33169-5510
      • Oceanic Research Group /ID# 263032
    • Okeechobee, Florida, United States, 34972-2568
      • Health Synergy Clinical Research LLC /ID# 262998
    • Tampa, Florida, United States, 33629-5837
      • Interventional Psychiatry of Tampa Bay /ID# 253526
  • New York
    • Monsey, New York, United States, 10952-1233
      • Richard Louis Price, M.D., LLC /ID# 253527

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with Bipolar 1 Disorder or Unipolar Major Depressive Disorder

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Actual): August 16, 2024
• Study Completion (Actual): August 16, 2024

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Bipolar I Disorder (BP1); Unipolar major depressive disorder (MDD); Rapid Mood Screener (RMS)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: H23-890

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No