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NCT05956483Completed

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

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

Source: ClinicalTrials.gov · Last updated 20 Aug 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
423 (actual)
First submitted
14 Jul 2023
Start date
4 Dec 2023
Primary completion date
16 Aug 2024
Lead sponsor
AbbVie
NCT number
NCT05956483

What you commit to

  • Study type: Observational
  • Participants enrolled: 423
  • From 4 Dec 2023 to the primary completion date, 16 Aug 2024
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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).

Other

  • Hospitalized or admitted to the emergency room due to mental health issues in the past 30 days.
  • Currently experiencing a manic episode.
  • Participant did not provide informed consent.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ATP Clinical Research, Inc /ID# 255223
Coordinator of this site? Confirm its status
Costa MesaUnited StatesUnknown status
CT Clinical Research /ID# 253488
Coordinator of this site? Confirm its status
CromwellUnited StatesUnknown status
J&A Clinical Research /ID# 263034
Coordinator of this site? Confirm its status
DoralUnited StatesUnknown status
UHC Research /ID# 263151
Coordinator of this site? Confirm its status
DoralUnited StatesUnknown status
MedOne Clinical Research /ID# 263031
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Richard Louis Price, M.D., LLC /ID# 253527
Coordinator of this site? Confirm its status
MonseyUnited StatesUnknown status
Oceanic Research Group /ID# 263032
Coordinator of this site? Confirm its status
North Miami BeachUnited StatesUnknown status
Health Synergy Clinical Research LLC /ID# 262998
Coordinator of this site? Confirm its status
OkeechobeeUnited StatesUnknown status
Interventional Psychiatry of Tampa Bay /ID# 253526
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.