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

Bipolar I Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05956483
• Other study ID #: H23-890
• Status: Not yet recruiting
• Start date: July 15, 2023
• Est. completion date: June 28, 2024

Study information

• Verified date: July 2023
• Source: AbbVie
• Contact: Anita Johnson
• Phone: 847-936-5375
• Email: anita.johnson[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 404
• Est. completion date: June 28, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar I Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Predictive Value (PPV) of Rapid Mood Screener (RMS)	PPV is defined as True Positive(TP)/(TP + False Positive (FP)).	Day 1
Primary	Negative Predictive Value (NPV) of Rapid Mood Screener (RMS)	NPV is defined as True Negative(TN)/(TN + False Negative (FN)).	Day 1
Primary	Sensitivity of Rapid Mood Screener (RMS)	Sensitivity is defined as TP/(TP+FN).	Day 1
Primary	Specificity of Rapid Mood Screener (RMS)	Specificity is defined as TN/(TN+FP).	Day 1

External Links

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