NCT05956483

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
423

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

December 4, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

July 14, 2023

Last Update Submit

August 19, 2024

Conditions

Bipolar I Disorder

Keywords

Bipolar I Disorder (BP1)Unipolar major depressive disorder (MDD)Rapid Mood Screener (RMS)

Outcome Measures

Primary Outcomes (4)

  • Positive Predictive Value (PPV) of Rapid Mood Screener (RMS)

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

    Day 1

  • Negative Predictive Value (NPV) of Rapid Mood Screener (RMS)

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

    Day 1

  • Sensitivity of Rapid Mood Screener (RMS)

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

    Day 1

  • Specificity of Rapid Mood Screener (RMS)

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

    Day 1

Study Arms (1)

Rapid Mood Screener (RMS)

Participants with Unipolar Major Depressive Disorder and Bipolar 1 Depression will be evaluated with RMS questionnaire and MINI interview.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants with Bipolar 1 Disorder or Unipolar Major Depressive Disorder

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

ATP Clinical Research, Inc /ID# 255223

Costa Mesa, California, 92626-4607, United States

Location

CT Clinical Research /ID# 253488

Cromwell, Connecticut, 06416, United States

Location

UHC Research /ID# 263151

Doral, Florida, 33126-1829, United States

Location

J&A Clinical Research /ID# 263034

Doral, Florida, 33126-1834, United States

Location

MedOne Clinical Research /ID# 263031

Miami, Florida, 33145, United States

Location

Oceanic Research Group /ID# 263032

North Miami Beach, Florida, 33169-5510, United States

Location

Health Synergy Clinical Research LLC /ID# 262998

Okeechobee, Florida, 34972-2568, United States

Location

Interventional Psychiatry of Tampa Bay /ID# 253526

Tampa, Florida, 33629-5837, United States

Location

Richard Louis Price, M.D., LLC /ID# 253527

Monsey, New York, 10952-1233, United States

Location

Related Links

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2023

First Posted

July 21, 2023

Study Start

December 4, 2023

Primary Completion

August 16, 2024

Study Completion

August 16, 2024

Last Updated

August 20, 2024

Record last verified: 2024-08

Locations

US(9)