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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
EV-SoPRANO 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.Check my eligibility
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.See study design
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.
EV-SoPRANO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 8 and 17 years old and have a parent or guardian.
Select...
None of my immediate family has mental health disorders.
Select...
I use a vaginal ring or contraceptive implant for birth control.
Select...
I use an IUD or diaphragm and a condom for birth control.
Select...
I have no major health issues and am not pregnant.
Select...
I have been diagnosed with anxiety without a history of mania, OCD, or major trauma.
Select...
I am between 8 and 17 years old and have a parent or guardian.
Select...
I have undergone surgical sterilization.
Select...
I use skin patches or injections for birth control.
Select...
I am currently using oral contraceptives.
EV-SoPRANO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2
Side effects data
From 2009 Phase 4 trial • 38 Patients • NCT001599655%
tiredness/ sleepiness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sertraline
EV-SoPRANO 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
428 Previous Clinical Trials
634,244 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
1,964 Previous Clinical Trials
2,672,409 Total Patients Enrolled
4 Trials studying Anxiety Disorders
340 Patients Enrolled for Anxiety Disorders
Jeffrey R Strawn, MD, FAACAPPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
84 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an allergic reaction to sertraline in the past.You have a mental health condition related to mood, except for a few specific types. However, if you have anxiety disorder(s) as your primary diagnosis, you may still be eligible.I am between 8 and 17 years old and have a parent or guardian.I do not have eating, bipolar, or psychotic disorders.None of my immediate family has mental health disorders.You are currently at risk of harming yourself, which could affect the study's results.I use a vaginal ring or contraceptive implant for birth control.I use an IUD or diaphragm and a condom for birth control.I haven't taken SSRIs in the last 12 weeks or am not on long-lasting CNS drugs.I have no major health issues and am not pregnant.I have been diagnosed with anxiety without a history of mania, OCD, or major trauma.I have had a major illness, head injury, or was unconscious for 5+ minutes.My psychotherapy has been stable for less than 2 months before my second visit.You have had problems with drugs or alcohol in the past 6 months.You have a history of severe mood swings, obsessive-compulsive behavior, or have experienced significant traumatic events.I cannot swallow capsules.I am between 8 and 17 years old and have a parent or guardian.I have undergone surgical sterilization.I live too far from the University of Cincinnati to attend follow-up visits.I am not pregnant, breastfeeding, or lactating.I am using a reliable birth control method and will continue for the study duration.I use skin patches or injections for birth control.I am currently using oral contraceptives.
Research Study Groups:
This trial has the following groups:- Group 1: sertraline
- Group 2: Placebo
- Group 3: Healthy Control
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is sertraline administration known to be associated with any risks?
"With Phase 4 trials supporting the safety of sertraline, this medication was given a score of 3."
Answered by AI
Does this investigation accept participants aged twenty-five or older?
"To be accepted into this study, participants must between 8 and 17 years of age. Moreover, there are 113 other trials available for minors while 282 can cater to seniors."
Answered by AI
Are there any vacancies for patients in this clinical trial?
"Affirmative. Data accessible on clinicaltrials.gov reveals that this trial is presently recruiting patients, which began November 1st 2019 and was last updated February 14th 2022. 150 participants must be sourced from 2 medical centres for the study to progress."
Answered by AI
Could you elaborate on the experiments that have been conducted with sertraline?
"The first exploratory trials of sertraline began at Vanderbilt University Autonomic Dysfunction Center in 1997. Since then, 158 studies have been completed while 12 are still ongoing; many of these clinical sites lie within the boroughs of New york City."
Answered by AI
For what afflictions is sertraline typically prescribed?
"Sertraline is a viable option for managing premenstrual dysphoric disorder, anxiety disorders, and binge eating disorder."
Answered by AI
What is the enrolment cap for this research study?
"Affirmative. Clinicaltrials.gov data shows that this clinical trial, initially advertised on November 1st 2019, is currently recruiting participants. 150 people are needed from two different medical sites alike."
Answered by AI
What are the eligibility requirements for participating in this experiment?
"This clinical study seeks to enrol 150 children aged 8-17 suffering from anxiety disorders. Eligible candidates must comply with the criteria stipulated by DSM-5, have a PARS score of 15 or higher at both Visit 1 and 2, pass physical examinations without any abnormalities, be nonpregnant if female, and utilise reliable contraception methods throughout the trial period as well as 30 days afterwards."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
University of Columbia, New York State Psychiatric Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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