Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04598230 · ClinicalTrials.gov registry record · Phase 3
Partners in Caring for Anxious Youth
A Phase 3 study of Anxiety, Separation and Anxiety Generalized, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Active
- Registry status
- Phase 3
- Development phase
- 468
- Enrollment target
- 3
- Study locations
NCT04598230: Active Phase 3 study of Anxiety, Separation and Anxiety Generalized, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
NCT04598230 is a Phase 3 study of Anxiety, Separation and Anxiety Generalized that is active but no longer recruiting, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 468 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04598230, a Phase 3 study of Anxiety, Separation and Anxiety Generalized, is active but no longer recruiting, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 468 participants
- Enrollment target
- 3
- Study locations
Study Summary
Pediatric onset anxiety disorders (generalized anxiety, social anxiety, separation anxiety) are highly prevalent, and if untreated, are impairing into adolescence and adulthood. In the largest comparative efficacy study remission occurred in about 65% of children and adolescents treated with a combination of a selective serotonin reuptake inhibitors (SSRI) and cognitive behavioral therapy (CBT). In contrast, CBT without an SSRI achieved remission in 35% of children at 3 months and 45% at 6 months-a 30% and 20% difference, respectively. Despite the difference in remission rates, CBT alone is the preferred treatment of most patients and families. Lack of awareness of the significant difference in remission rates and concerns about medication side effects may drive patient and family preference even though SSRIs have a positive safety profile. Critiques of CBT in the above study suggest that CBT was not as effective as it could be due to short treatment duration, restricted family involvement and limited exposure sessions. Would the combination of CBT and an SSRI still be superior to CBT only, if CBT was of longer duration, and included more family involvement and exposure sessions? In the Partners in Care for Anxious Youth (PCAY) study, children and adolescents with an anxiety disorder ages 7-17 years followed in pediatric primary care clinics affiliated with three institution: Lurie Children's Hospital of Chicago, University of California Los Angeles and University of Cincinnati will be randomized to one of two treatment arms; either CBT only or CBT combined with an SSRI (either fluoxetine, sertraline, or escitalopram). CBT in PCAY will be 6 months in duration and include more family involvement, and more exposure opportunities than past trials. The 6-month acute treatment phase will be followed by 6 months of followup. The primary outcome will be anxiety symptom remission and reduction in impairment over 6 and 12-months.
Primary Outcome
The CGI-S score provides a global rating of anxiety symptom severity ranging from 1 (not at all ill) to 7 (extremely ill). The CGI-S is commonly used in clinical trials and will allow us to benchmark across prior studies in the field.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy (CBT)
- DRUG Combination therapy (COMB)
Study Locations (3)
California
- UCLA Semel Institute for Neuroscience and Human Behavior - Los Angeles
Illinois
- Lurie Children's Hospital and Affiliated Pediatric Practices - Chicago
Ohio
- University of Cincinnati - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 468 participants |
| Start Date | 2021-02-09 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What the registry record for NCT04598230 still lists
NCT04598230 is an interventional study that assigns participants to a tested intervention. The registered 468 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower).
The record links to 3 conditions, with Anxiety, Separation appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Behavioral Therapy (CBT) is the first listed.
NCT04598230 reports a single indexed study location in California, Illinois, Ohio.
Frequently Asked Questions
What is clinical trial NCT04598230 about?
NCT04598230 is a clinical study titled "Partners in Caring for Anxious Youth". Pediatric onset anxiety disorders (generalized anxiety, social anxiety, separation anxiety) are highly prevalent, and if untreated, are impairing into adolescence and adulthood. In the largest comparative efficacy study remission occurred in about 65% of children and adolescents treated with a combi...
What is the current status of trial NCT04598230?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 468 participants. The study started on 2021-02-09. Estimated completion is 2026-12-31.
What conditions does trial NCT04598230 study?
This clinical trial studies the following conditions: Anxiety, Separation, Anxiety Generalized, Anxiety, Social.
What interventions are being tested in trial NCT04598230?
The interventions under investigation include: Cognitive Behavioral Therapy (CBT) (BEHAVIORAL), Combination therapy (COMB) (DRUG).
Who is sponsoring clinical trial NCT04598230?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04598230 being conducted?
This trial has 3 study locations across California, Illinois, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anxiety, Separation
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 NCT04598230's enrollment target sits among peer trials
468 816th of 2000 higher than 1,185 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03124303 · 468 participants
Interventions for Postoperative Delirium: Biomarker-3
- NCT03901924 · 468 participants · NA
Volume Support/Assist Control Mode Ventilation and Diaphragmatic Atrophy
- NCT04482309 · 468 participants · Phase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
- NCT05357170 · 468 participants
Microbiome Dysfunction in Surgical Intensive Care Unit Survivors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI