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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

423 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-04

Study Completion Date

2024-08-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Bipolar I Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rapid Mood Screener (RMS)

Participants with Unipolar Major Depressive Disorder and Bipolar 1 Depression will be evaluated with RMS questionnaire and MINI interview.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No