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Selective Serotonin Reuptake Inhibitor

Sertraline for Anxiety Disorders (EV-SoPRANO Trial)

Phase 4
Recruiting
Led By Jeffrey R Strawn, MD, FAACAP
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
8-17 years of age, inclusive, at Visit 1, and who have a parent/guardian/LAR.
No first-degree relatives with an affective, anxiety or psychotic disorder.
Must not have
eating, bipolar, or psychotic disorders.
A history of treatment with SSRIs within 12 weeks of Visit 2 (Baseline) or current pharmacotherapy with CNS effects that require >5 half-lives for discontinuation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial tested whether the drug sertraline is effective in treating acute depression.

Who is the study for?
This trial is for children and teens aged 8-17 with generalized, social, or separation anxiety disorders. They must be able to use contraception if sexually active, have no major psychiatric or neurological conditions other than anxiety, not be on certain medications recently, and commit to the study schedule.
What is being tested?
The trial tests Sertraline's effectiveness in treating youth with anxiety disorders compared to a placebo. It's a multicenter study where participants are randomly assigned to receive either Sertraline or a dummy pill without knowing which one they're getting.
What are the potential side effects?
Sertraline can cause side effects like nausea, headaches, sleep problems, increased sweating, fatigue and might affect appetite. Some may experience more serious effects such as mood changes but these vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 8 and 17 years old and have a parent or guardian.
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None of my immediate family has mental health disorders.
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I use a vaginal ring or contraceptive implant for birth control.
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I use an IUD or diaphragm and a condom for birth control.
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I have no major health issues and am not pregnant.
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I have been diagnosed with anxiety without a history of mania, OCD, or major trauma.
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I am between 8 and 17 years old and have a parent or guardian.
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I have undergone surgical sterilization.
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I use skin patches or injections for birth control.
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I am currently using oral contraceptives.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have eating, bipolar, or psychotic disorders.
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I haven't taken SSRIs in the last 12 weeks or am not on long-lasting CNS drugs.
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I have had a major illness, head injury, or was unconscious for 5+ minutes.
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I cannot swallow capsules.
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I live too far from the University of Cincinnati to attend follow-up visits.
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I am not pregnant, breastfeeding, or lactating.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2

Side effects data

From 2009 Phase 4 trial • 38 Patients • NCT00159965
5%
tiredness/ sleepiness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sertraline

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: sertralineExperimental Treatment1 Intervention
90 patients will be randomized to sertraline
Group II: Healthy ControlActive Control1 Intervention
30 healthy comparison subjects will be followed over the course of 12 weeks
Group III: PlaceboPlacebo Group1 Intervention
30 patient will be randomized to placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sertraline
2006
Completed Phase 4
~4030

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
436 Previous Clinical Trials
635,212 Total Patients Enrolled
6 Trials studying Anxiety Disorders
945 Patients Enrolled for Anxiety Disorders
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,744 Total Patients Enrolled
4 Trials studying Anxiety Disorders
344 Patients Enrolled for Anxiety Disorders
Jeffrey R Strawn, MD, FAACAPPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
84 Total Patients Enrolled

Media Library

Sertraline (Selective Serotonin Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04221997 — Phase 4
Anxiety Disorders Research Study Groups: sertraline, Placebo, Healthy Control
Anxiety Disorders Clinical Trial 2023: Sertraline Highlights & Side Effects. Trial Name: NCT04221997 — Phase 4
Sertraline (Selective Serotonin Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04221997 — Phase 4
~38 spots leftby Sep 2026
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