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 Identifier
H23-890
CT.gov Identifier
NCT05956483
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Bipolar Disorder
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    ATP Clinical Research, Inc /ID# 255223
    Costa Mesa, California, United States, 92626-4607
    Status
    Not applicable
    Location
    CT Clinical Research /ID# 253488
    Cromwell, Connecticut, United States, 06416
    Status
    Not applicable
    Location
    UHC Research /ID# 263151
    Doral, Florida, United States, 33126-1829
    Status
    Not applicable
    Location
    J&A Clinical Research /ID# 263034
    Doral, Florida, United States, 33126-1834
    Status
    Not applicable
    Location
    MedOne Clinical Research /ID# 263031
    Miami, Florida, United States, 33145
    Status
    Not applicable
    Location
    Oceanic Research Group /ID# 263032
    North Miami Beach, Florida, United States, 33169-5510
    Status
    Not applicable
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