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Combination Therapy for Anxiety Disorders (PCAY Trial)

Phase 3

Recruiting

Led By John Walkup, MD

Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 7-17 years (inclusive at time of consent/assent)

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the primary outcome is anxiety disorder remission based on a parent- and child-reported cgi-s rating of 1 (not at all ill) or 2 (borderline ill) at 12 months from first treatment visit

Awards & highlights

PCAY Trial Summary

This trial will help to determine if the combination of CBT and an SSRI is superior to CBT only, when CBT is of longer duration, and includes more family involvement and exposure sessions.

Who is the study for?

This trial is for children and teens aged 7-17 with separation anxiety, generalized anxiety, or social anxiety. They must be medically cleared and have a primary caretaker involved. It's not for those with certain severe psychiatric disorders, major medical illnesses that could interfere, or if they're pregnant without using birth control.Check my eligibility

What is being tested?

The study tests whether Cognitive Behavioral Therapy (CBT) alone or combined with an SSRI (fluoxetine, sertraline, escitalopram) is more effective in treating pediatric anxiety. The CBT will last 6 months with increased family involvement and exposure sessions followed by a 6-month follow-up.See study design

What are the potential side effects?

While the trial description does not list specific side effects of CBT or SSRIs used in this context, generally SSRIs can cause nausea, headaches, sleep disturbances and other side effects; CBT itself typically has no physical side effects but may initially increase distress as patients confront anxieties.

PCAY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 7 and 17 years old.

PCAY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the primary outcome is anxiety disorder remission based on a parent- and child-reported cgi-s rating of 1 (not at all ill) or 2 (borderline ill) at 12 months from first treatment visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the primary outcome is anxiety disorder remission based on a parent- and child-reported cgi-s rating of 1 (not at all ill) or 2 (borderline ill) at 12 months from first treatment visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and the primary outcome is anxiety disorder remission based on a parent- and child-reported cgi-s rating of 1 (not at all ill) or 2 (borderline ill) at 12 months from first treatment visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Anxiety

Clinical Global Impression-Severity Scale (CGI-S)

PCAY Trial Design

2Treatment groups

Active Control

Group I: Combination therapy (COMB)Active Control2 Interventions

Participants randomized to this arm will receive cognitive behavioral therapy and one of three study medications (fluoxetine, sertraline, or escitalopram).

Group II: Cognitive behavioral therapy (CBT)Active Control1 Intervention

Participants randomized to this arm will receive cognitive behavioral therapy (CBT) only

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CincinnatiOTHER

428 Previous Clinical Trials

633,926 Total Patients Enrolled

University of California, Los AngelesOTHER

1,530 Previous Clinical Trials

10,264,240 Total Patients Enrolled

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor

258 Previous Clinical Trials

5,188,662 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy (CBT) Clinical Trial Eligibility Overview. Trial Name: NCT04598230 — Phase 3

Separation Anxiety Research Study Groups: Combination therapy (COMB), Cognitive behavioral therapy (CBT)

Separation Anxiety Clinical Trial 2023: Cognitive Behavioral Therapy (CBT) Highlights & Side Effects. Trial Name: NCT04598230 — Phase 3

Cognitive Behavioral Therapy (CBT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04598230 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial have an age limit for participants?

"In order to participate in this research, patients must be within the age group of 7-17. Out of all the ongoing clinical trials, 124 are for people under 18 and 288 are for those over 65."

Answered by AI

For which patient group is this clinical trial designed?

"This clinical trial is looking for 468 people, between the ages of 7 and 17 who currently have anxiety, separation. It is required that participants also meet the following criteria: Primary Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosis of separation anxiety disorder (SAD), and/or generalized anxiety disorder (GAD), and/or social anxiety disorder (SocAD) as determined by self-reported structured interview (MINI-KID) and confirmation by a study clinician., Stable/treated Attention Deficit Hyperactivity Disorder (ADHD), combined or hyperactive impulsive subtypes,"

Answered by AI

How many volunteers are included in this research project?

"That is correct, the clinicaltrials.gov website lists this trial as currently recruiting 468 patients from 3 sites. The study was first posted on February 9th, 2021 and updated September 1st, 2021."

Answered by AI

What are some risks associated with CBT?

"There is some evidence of CBT's efficacy, as well as numerous reports vouching for its safety. Consequently, we've given it a rating of 3."

Answered by AI

Are people who meet the qualifications still able to join this experiment?

"Yes, the study is still recruiting patients. According to the information available on clinicaltrials.gov, the trial was posted on February 9th 2021 and edited September 1st 2021. The team conducting the trial are looking for 468 people total, at 3 different locations."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Cognitive Behavioral Therapy, Sertraline, or a Combination in Childhood Anxiety

Walkup, John T., Anne Marie Albano, John Piacentini, Boris Birmaher, Scott N. Compton, Joel T. Sherrill, Golda S. Ginsburg, et al.. 2008. “Cognitive Behavioral Therapy, Sertraline, or a Combination in Childhood Anxiety”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa0804633.

Journal of Child and Adolescent PsychopharmacologyJournal

Placebo Response in Pediatric Anxiety Disorders: Results from the Child/adolescent Anxiety Multimodal Study

Strawn, Jeffrey R., Eric T. Dobson, Jeffrey A. Mills, Gary J. Cornwall, Dara Sakolsky, Boris Birmaher, Scott N. Compton, et al.. 2017. “Placebo Response in Pediatric Anxiety Disorders: Results from the Child/adolescent Anxiety Multimodal Study”. Journal of Child and Adolescent Psychopharmacology. Mary Ann Liebert Inc. doi:10.1089/cap.2016.0198.

Journal of the American Academy of Child & Adolescent PsychiatryJournal

Child/adolescent Anxiety Multimodal Study: Evaluating Safety

Rynn, Moira A., John T. Walkup, Scott N. Compton, Dara J. Sakolsky, Joel T. Sherrill, Sa Shen, Philip C. Kendall, et al.. 2015. “Child/adolescent Anxiety Multimodal Study: Evaluating Safety”. Journal of the American Academy of Child & Adolescent Psychiatry. Elsevier BV. doi:10.1016/j.jaac.2014.12.015.

Journal of the American Academy of Child & Adolescent PsychiatryJournal