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OpenTrials
Completed

NCT Number: NCT05956483

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 (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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Key information

Conditions

Bipolar I Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ATP Clinical Research, Inc /ID# 255223, Costa Mesa, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Positive Predictive Value (PPV) of Rapid Mood Screener (RMS)

    Time frame: Day 1

    PPV is defined as True Positive(TP)/(TP + False Positive (FP)).

  2. Negative Predictive Value (NPV) of Rapid Mood Screener (RMS)

    Time frame: Day 1

    NPV is defined as True Negative(TN)/(TN + False Negative (FN)).

  3. Sensitivity of Rapid Mood Screener (RMS)

    Time frame: Day 1

    Sensitivity is defined as TP/(TP+FN).

  4. Specificity of Rapid Mood Screener (RMS)

    Time frame: Day 1

    Specificity is defined as TN/(TN+FP).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2023
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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