~29 spots leftby Sep 2026

Sertraline for Anxiety Disorders

(EV-SoPRANO Trial)

JR
Overseen byJeffrey R Strawn, MD, FAACAP
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Cincinnati
Must not be taking: SSRIs, CNS drugs
Disqualifiers: Mood, Eating, Bipolar, Psychotic, others
Prior Safety Data
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.

Will I have to stop taking my current medications?

The trial requires that participants have not used SSRIs (a type of antidepressant) within 12 weeks before starting the study and not be on medications affecting the central nervous system that need more than five half-lives to stop. This means you may need to stop certain medications before joining the trial.

What data supports the effectiveness of the drug sertraline for anxiety disorders?

Research shows that sertraline is effective in reducing panic attacks in people with panic disorder and is well-tolerated for treating various anxiety disorders, including obsessive-compulsive disorder and social anxiety.12345

Is sertraline generally safe for humans?

Sertraline, also known as Zoloft, has been shown to be safe for treating various conditions like depression, anxiety, and panic disorders. It is generally well-tolerated, but like all medications, it can have side effects. Studies have evaluated its safety in different settings, confirming its safety profile in humans.45678

How does the drug sertraline differ from other treatments for anxiety disorders?

Sertraline is unique because it is a selective serotonin reuptake inhibitor (SSRI) that has been extensively tested and proven effective for various anxiety disorders, including panic disorder and social anxiety, with a well-tolerated safety profile. It is comparable to other medications and therapies, such as cognitive behavioral therapy, and is considered a first choice among SSRIs for panic disorder due to its efficacy and tolerability.345910

Research Team

JR

Jeffrey R Strawn, MD, FAACAP

Principal Investigator

University of Cincinnati

Eligibility Criteria

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.

Inclusion Criteria

Caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient.
No clinically significant abnormalities on physical examination.
Negative pregnancy test at Visit 1 in females.
See 18 more

Exclusion 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 do not have eating, bipolar, or psychotic disorders.
See 10 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sertraline or placebo for 12 weeks, with plasma EVs collected at baseline and serially

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Sertraline (Selective Serotonin Reuptake Inhibitor)
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials
442
Recruited
639,000+
Dr. Greg Postel profile image

Dr. Greg Postel

University of Cincinnati

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

Dr. Neville G. Pinto profile image

Dr. Neville G. Pinto

University of Cincinnati

Chief Executive Officer since 2017

PhD in Chemistry from the University of Virginia

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+
Dr. Diana W. Bianchi profile image

Dr. Diana W. Bianchi

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich profile image

Dr. Alison Cernich

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Findings from Research

In a combined analysis of two multicenter clinical trials, sertraline significantly reduced the mean number of panic attacks per week in patients with panic disorder compared to placebo (4.8 vs. 2.5, p < .001).
Patients treated with sertraline also showed statistically significant improvements in various symptoms and functioning related to panic disorder, highlighting its efficacy as a treatment option.
Methodologies and outcomes from the sertraline multicenter flexible-dose trials.Rapaport, MH., Wolkow, RM., Clary, CM.[2013]
In a study of 84 older adults with anxiety disorders, both cognitive-behavioral therapy (CBT) and the SSRI sertraline significantly improved anxiety and depressive symptoms, but sertraline was more effective in reducing worry symptoms.
The effect sizes indicated that sertraline had a large impact on anxiety (mean d = 0.94) compared to CBT, which had a small to medium effect (mean d = 0.42), highlighting the potential underappreciation of SSRIs in treating anxiety in older adults.
A randomized, controlled trial of the effectiveness of cognitive-behavioral therapy and sertraline versus a waitlist control group for anxiety disorders in older adults.Schuurmans, J., Comijs, H., Emmelkamp, PM., et al.[2022]
Sertraline is an effective and well-tolerated treatment for various anxiety disorders, including panic disorder and obsessive-compulsive disorder, based on extensive research from controlled and open trials.
When compared to other medications for anxiety disorders, sertraline demonstrates at least equivalent efficacy, making it a viable option for patients seeking treatment.
Sertraline in the treatment of anxiety disorders.Hirschfeld, RM.[2022]

References

Methodologies and outcomes from the sertraline multicenter flexible-dose trials. [2013]
A randomized, controlled trial of the effectiveness of cognitive-behavioral therapy and sertraline versus a waitlist control group for anxiety disorders in older adults. [2022]
Sertraline in the treatment of anxiety disorders. [2022]
Coadministration of sertraline with cisapride or pimozide: an open-label, nonrandomized examination of pharmacokinetics and corrected QT intervals in healthy adult volunteers. [2022]
Sertraline in the treatment of panic disorder: a flexible-dose multicenter trial. [2022]
Sertraline in the treatment of panic disorder. A multi-site, double-blind, placebo-controlled, fixed-dose investigation. [2022]
Adverse events in users of sertraline: results from an observational study in psychiatric practice in The Netherlands. [2022]
8.Bosnia and Herzegovinapubmed.ncbi.nlm.nih.gov
Sertraline and alprazolam in the treatment of panic desorder. [2022]
Efficacy of sertraline in severe generalized social anxiety disorder: results of a double-blind, placebo-controlled study. [2022]
Sertraline in the treatment of panic disorder. [2022]