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Selective Serotonin Reuptake Inhibitor

Escitalopram for Anxiety (PrEcISE Trial)

Phase 4

Recruiting

Led By Jeffrey R. Strawn,, MD

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

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

Must have

12 to 17 years of age, inclusive, at Visit 1.

Negative pregnancy test at Visit 1 in females

Must not have

Patients who are unable to swallow capsules

Major neurological or medical illness or head trauma with ≥5 minutes loss of consciousness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 12/early termination

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will test whether a person's metabolism affects how they respond to the drug escitalopram. 132 people will be given the drug and monitored for 12 weeks.

Who is the study for?

This trial is for youths aged 12-17 with generalized, social, or separation anxiety disorder. They must have a certain severity of anxiety, no recent psychotherapy initiation, and be English-speaking. Participants need normal physical exams and EKGs, not be pregnant or drug-positive, and use reliable contraception if sexually active.

What is being tested?

The study tests escitalopram dosing in anxious youth over 12 weeks. It's double-blind with participants randomly assigned to standard dosing or doses guided by their genetics. The randomization considers sex and how well their body processes drugs.

What are the potential side effects?

Escitalopram may cause side effects like nausea, sleep issues (insomnia or excessive sleepiness), increased sweating, fatigue, dry mouth, sexual dysfunction and could increase the risk of suicidal thoughts especially in young people.

Eligibility Criteria

Inclusion Criteria

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

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I am between 12 and 17 years old.

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I have taken a pregnancy test and it was negative.

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I am between 12 and 17 years old.

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I have been diagnosed with anxiety disorder.

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My drug test at the first visit was negative.

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I am using or willing to use an approved method of birth control during the study.

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My physical exam and heart test results are normal.

Exclusion Criteria

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

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I cannot swallow pills.

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I have had a major illness or head injury that caused me to lose consciousness for 5 minutes or more.

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I live more than 90 minutes away from the treatment center or cannot attend follow-up visits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12/early termination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12/early termination

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12/early termination for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pediatric Anxiety Rating Scale severity score

Secondary study objectives

Tolerability-Activation

Side effects data

From 2019 Phase 4 trial • 115 Patients • NCT01902004

23%

Sleepiness/Sedation

10%

Headache

Tension/Inner Unrest

Reduced Salivation

Concentration Difficulties

Diminished Sexual Drive

Asthenia/Lassitude/Increased Fatigability

Constipation

Polyuria/Polydipsia

Orthostatic Dizziness

Nausea/Vomiting

Erectile Dysfunction

Failing Memory

Diarrhea

Increased Duration of Sleep

Reduced Duration of Sleep

Increased Dream Activity

Accomodation Disturbance

Increased Tendancy to Sweating

Weight Gain

Ejaculatory Dysfunction

Micturtion Disturbances

100%

80%

60%

40%

20%

Study treatment Arm

Escitalopram and Placebo

Escitalopram and Memantine

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard dosingExperimental Treatment1 Intervention

Patients randomized to standard dosing (std) will initiate escitalopram at 5 mg daily and will then increase to 20 mg/day at week 4.

Group II: Pharmacogenetically-guided escitalopram dosingExperimental Treatment1 Intervention

Patients randomized to PGx-guided treatment, escitalopram titration will be based on CYP2C19 phenotype and predicted escitalopram exposure. In poor metabolizers (PM), escitalopram will be initiated at 5 mg daily and increased to 10 mg daily at week 4.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Escitalopram

2005

Completed Phase 4

~2330

0 / 10Eligibility criteria met