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NCT05956483 · ClinicalTrials.gov registry record
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 clinical trial, sponsored by AbbVie.
- Completed
- Registry status
- 423
- Enrollment target
NCT05956483: Completed study, sponsored by AbbVie.
NCT05956483 is a clinical trial that has completed, run by AbbVie. The registered enrollment target is 423 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05956483 has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- 423 participants
- Enrollment target
Study 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.
Primary Outcome
PPV is defined as True Positive(TP)/(TP + False Positive (FP)).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 423 participants |
| Start Date | 2023-12-04 |
| Est. Completion | 2024-08-16 |
What the finished NCT05956483 record still lists
NCT05956483 is an observational study that tracks outcomes without assigning an intervention. The registered 423 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT05956483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05956483 about?
NCT05956483 is a clinical study titled "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...
What is the current status of trial NCT05956483?
This trial is currently completed. The enrollment target is 423 participants. The study started on 2023-12-04. Estimated completion is 2024-08-16.
Who is sponsoring clinical trial NCT05956483?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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