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

Completed

Conditions studied: Bipolar I Disorder

In brief

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.

Key facts

Study ID

NCT05956483

Run by

AbbVie

People needed

423

Starts

2023-12-04

Expected to finish

2024-08-16

Last updated by the study team

2024-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• ATP Clinical Research, Inc /ID# 255223 — Costa Mesa, California, United States
• CT Clinical Research /ID# 253488 — Cromwell, Connecticut, United States
• UHC Research /ID# 263151 — Doral, Florida, United States
• J&A Clinical Research /ID# 263034 — Doral, Florida, United States
• MedOne Clinical Research /ID# 263031 — Miami, Florida, United States
• Oceanic Research Group /ID# 263032 — North Miami Beach, Florida, United States
• Health Synergy Clinical Research LLC /ID# 262998 — Okeechobee, Florida, United States
• Interventional Psychiatry of Tampa Bay /ID# 253526 — Tampa, Florida, United States
• Richard Louis Price, M.D., LLC /ID# 253527 — Monsey, New York, United States

Full record on ClinicalTrials.gov

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