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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

Must not have

Patients or caregivers who do not speak English or Spanish

Primary Attention Deficit Hyperactivity Disorder (ADHD), combined or hyperactive impulsive subtypes

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

Pivotal Trial

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am between 7 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I or my caregiver do not speak English or Spanish.

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I have been diagnosed with ADHD, either the combined or hyperactive/impulsive type.

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My depression is more severe than my anxiety and needs treatment outside of primary care.

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My child has complex mental health needs that require specialized care.

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My anxiety hasn't improved with medication or therapy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Anxiety

Clinical Global Impression-Severity Scale (CGI-S)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met