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NCT05427123 · ClinicalTrials.gov registry record
Children's Bipolar Network Treatment Trial I
A clinical trial of Bipolar Disorder and Bipolar I Disorder, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- 80
- Enrollment target
- 4
- Study locations
NCT05427123: Recruiting study of Bipolar Disorder and Bipolar I Disorder, sponsored by University of California, Los Angeles.
NCT05427123 is a study of Bipolar Disorder and Bipolar I Disorder that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 80 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (76% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05427123, a study of Bipolar Disorder and Bipolar I Disorder, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- 80 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a naturalistic treatment and follow-up study of youth with bipolar spectrum disorders (BSDs) across four US sites of The Childhood Bipolar Network (CBN). CBN sites have expertise in diagnosing, assessing, and treating BSDs in youth. The primary aims of this study are to (1) identify and reliably diagnose youth (ages 9 to 19 yrs) with full bipolar disorder (BD) and BSDs, and (2) examine predictors (e.g., mood instability, inflammatory marker C-reactive protein) of clinical outcome over a 12 month period. Participating youth will initially complete a screening that includes a structured diagnostic interview and a baseline blood draw to measure inflammatory processes. Youth with BSD and parents (80 families) will be asked to participate in multiple follow up research visits with interviews, rating instruments, and questionnaires. Per established CBN guidelines, study psychiatrists will provide and track medication management and sites will also track psychosocial treatments. This study ultimately aims to further understanding of best practice pediatric BSD psychiatric and psychosocial treatments and development of a standardized and validated set of clinical tools for patient assessment, diagnosis, and tracking.
Primary Outcome
The A-LIFE is a measure of severity of youth mood symptoms and episodes, including first episode onset, duration, recovery, and recurrence. Independent evaluators administer the A-LIFE interview to the youth and one parent, and rate each week of the prior 6 month interval (i.e., 6 months prior to intake) on Psychiatric Status Ratings (PSRs) of depression, hypomania, mania, and suicidality. The minimum and maximum Psychiatric Status Ratings values are 0 and 6 respectively, with higher Psychiatric
Conditions Studied
Interventions
- OTHER Medication or psychosocial treatment
Study Locations (4)
California
- University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP) - Los Angeles
Colorado
- University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center - Aurora
Pennsylvania
- University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS) - Pittsburgh
Virginia
- Virginia Commonwealth University Medical Center - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-07-01 |
| Est. Completion | 2027-07-01 |
What NCT05427123 shows while recruiting
NCT05427123 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (76% lower).
The record links to 7 conditions, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention - of which Medication or psychosocial treatment is the first listed.
NCT05427123 reports a single indexed study location in California, Colorado, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05427123 about?
NCT05427123 is a clinical study titled "Children's Bipolar Network Treatment Trial I". This is a naturalistic treatment and follow-up study of youth with bipolar spectrum disorders (BSDs) across four US sites of The Childhood Bipolar Network (CBN). CBN sites have expertise in diagnosing, assessing, and treating BSDs in youth. The primary aims of this study are to (1) identify and reli...
What is the current status of trial NCT05427123?
This trial is currently recruiting. The enrollment target is 80 participants. The study started on 2022-07-01. Estimated completion is 2027-07-01.
What conditions does trial NCT05427123 study?
This clinical trial studies the following conditions: Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder, Adolescent - Emotional Problem, Child Mental Disorder.
What interventions are being tested in trial NCT05427123?
The interventions under investigation include: Medication or psychosocial treatment (OTHER).
Who is sponsoring clinical trial NCT05427123?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05427123 being conducted?
This trial has 4 study locations across California, Colorado, Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05427123's enrollment target sits among peer trials
80 76th of 162 higher than 85 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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