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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05956483

Enrollment

423

Registered

2023-07-21

Start date

2023-12-04

Completion date

2024-08-16

Last updated

2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar I Disorder

Keywords

Bipolar I Disorder (BP1), Unipolar major depressive disorder (MDD), Rapid Mood Screener (RMS)

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

United States

Outcome results