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

Sponsor

AbbVie (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05956483

Collaborator

(none)

404

Enrollment

11.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar I Disorder

Study Design

Study Type:

Observational

Anticipated Enrollment :

404 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Jul 15, 2023

Anticipated Primary Completion Date :

Jun 28, 2024

Anticipated Study Completion Date :

Jun 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Rapid Mood Screener (RMS) Participants with Unipolar Major Depressive Disorder and Bipolar 1 Depression will be evaluated with RMS questionnaire and MINI interview.

Outcome Measures

Primary Outcome Measures

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)).
Sensitivity of Rapid Mood Screener (RMS) [Day 1]
Sensitivity is defined as TP/(TP+FN).
Specificity of Rapid Mood Screener (RMS) [Day 1]
Specificity is defined as TN/(TN+FP).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.