Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar I Disorder
Keywords: Bipolar I Disorder (BP1)
Unipolar major depressive disorder (MDD)
Rapid Mood Screener (RMS)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-07-21
Enrollment: 423
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with Bipolar 1 Disorder or Unipolar Major Depressive Disorder

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Positive Predictive Value (PPV) of Rapid Mood Screener (RMS)
timeFrame: Day 1
measure: Negative Predictive Value (NPV) of Rapid Mood Screener (RMS)
timeFrame: Day 1
measure: Sensitivity of Rapid Mood Screener (RMS)
timeFrame: Day 1
measure: Specificity of Rapid Mood Screener (RMS)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc /ID# 255223
state: California
city: Cromwell
country: United States
facility: CT Clinical Research /ID# 253488
state: Connecticut
city: Doral
country: United States
facility: UHC Research /ID# 263151
state: Florida
city: Doral
country: United States
facility: J&A Clinical Research /ID# 263034
state: Florida
city: Miami
country: United States
facility: MedOne Clinical Research /ID# 263031
state: Florida
city: North Miami Beach
country: United States
facility: Oceanic Research Group /ID# 263032
state: Florida
city: Okeechobee
country: United States
facility: Health Synergy Clinical Research LLC /ID# 262998
state: Florida
city: Tampa
country: United States
facility: Interventional Psychiatry of Tampa Bay /ID# 253526
state: Florida
city: Monsey
country: United States
facility: Richard Louis Price, M.D., LLC /ID# 253527
state: New York
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: