Sertraline for Anxiety Disorders

(EV-SoPRANO Trial)

Overseen By Jeffrey R Strawn, MD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Cincinnati

Must not be taking: SSRIs, CNS drugs

Disqualifiers: Mood, Eating, Bipolar, Psychotic, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

150 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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. ^{1 2 5 9 10}

Research Team

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.

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.

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

Trial Overview 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.

Participant Groups

Group I: sertraline Experimental Treatment 1 Intervention

90 patients will be randomized to sertraline

Group II: Healthy Control Active Control 1 Intervention

30 healthy comparison subjects will be followed over the course of 12 weeks

Group III: Placebo Placebo Group 1 Intervention

30 patient will be randomized to placebo

Sertraline is already approved in United States, European Union for the following indications:

Approved in United States as Zoloft for:

• Depression
• Obsessive-compulsive disorder (OCD)
• Panic disorder
• Post-traumatic stress disorder (PTSD)
• Premenstrual dysphoric disorder (PMDD)
• Social anxiety disorder

Approved in European Union as Sertraline for:

• Major depressive episodes
• Panic disorder
• Obsessive compulsive disorder
• Social anxiety disorder
• Post traumatic stress disorder
• Premenstrual dysphoric disorder

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Coadministration of sertraline with cisapride significantly reduced cisapride plasma concentrations (by 29% for Cmax and 36% for AUC), but did not affect QTc intervals, indicating a safe interaction.

In contrast, sertraline increased pimozide plasma concentrations (by 35% for Cmax and 37% for AUC) without prolonging QTc intervals, suggesting that the interaction mechanisms may involve factors beyond the CYP3A4 enzyme.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coadministration of sertraline with cisapride or pimozide: an open-label, nonrandomized examination of pharmacokinetics and corrected QT intervals in healthy adult volunteers. Alderman, J.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sertraline in the treatment of anxiety disorders. Hirschfeld, RM.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 176 nondepressed outpatients with panic disorder, sertraline hydrochloride significantly reduced panic attack frequency compared to placebo over a 10-week treatment period.

Sertraline was found to be safe, with adverse events being mostly mild or moderate and not significantly different from those in the placebo group, supporting its use for short-term treatment of panic disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sertraline in the treatment of panic disorder: a flexible-dose multicenter trial. Pollack, MH., Otto, MW., Worthington, JJ., et al.[2022]

In a study of 178 out-patients with panic disorder, sertraline significantly reduced the frequency of panic attacks and anxiety symptoms compared to placebo over 12 weeks, demonstrating its efficacy in treating panic disorder.

Sertraline was found to be safe, with no serious adverse events reported, although some patients experienced mild side effects like dry mouth and ejaculation issues, and higher doses did not provide additional benefits over the 50 mg dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sertraline in the treatment of panic disorder. A multi-site, double-blind, placebo-controlled, fixed-dose investigation. Londborg, PD., Wolkow, R., Smith, WT., et al.[2022]

In a study involving 1251 patients, sertraline was found to have a similar safety profile to other SSRIs, with common side effects like nausea, headache, and diarrhea reported by both groups.

Despite the similarities, sertraline users reported a higher incidence of diarrhea compared to users of other SSRIs, and the study identified over 100 different unlabelled adverse events, indicating the need for ongoing monitoring of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in users of sertraline: results from an observational study in psychiatric practice in The Netherlands. Meijer, WE., Heerdink, ER., van Eijk, JT., et al.[2022]

In a 12-week study involving 40 patients with panic disorder, both sertraline (20 mg/day) and alprazolam (1-1.5 mg/day) significantly reduced the frequency of panic attacks, as well as symptoms of agoraphobia and anticipatory anxiety.

The study's design was a placebo-controlled, fixed-dose trial, indicating that both medications are effective options for treating panic disorder with and without agoraphobia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sertraline and alprazolam in the treatment of panic desorder. Fiseković, S., Loga-Zec, S.[2022]

In a study involving 211 adults with severe generalized social anxiety disorder, sertraline significantly reduced anxiety symptoms compared to placebo, as measured by the Liebowitz Social Anxiety Scale, with a mean score change of -31.0 for sertraline versus -21.7 for placebo.

Sertraline was well tolerated, with only 7.6% of patients discontinuing due to side effects, indicating it is a safe option for treating this chronic condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of sertraline in severe generalized social anxiety disorder: results of a double-blind, placebo-controlled study. Liebowitz, MR., DeMartinis, NA., Weihs, K., et al.[2022]

Sertraline is an effective and well-tolerated treatment for panic disorder (PD), with studies showing it reduces the severity and frequency of panic attacks and provides protection from relapse for up to 36 weeks after stopping the medication.

In an 80-week relapse prevention trial, sertraline demonstrated comparable efficacy to cognitive behavioral therapy, making it a strong candidate as a first-choice treatment among serotonin reuptake inhibitors for patients with PD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sertraline in the treatment of panic disorder. Hobgood, CD., Clayton, AH.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Coadministration of sertraline with cisapride or pimozide: an open-label, nonrandomized examination of pharmacokinetics and corrected QT intervals in healthy adult volunteers. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Sertraline in the treatment of anxiety disorders. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Methodologies and outcomes from the sertraline multicenter flexible-dose trials. [2013]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Sertraline in the treatment of panic disorder: a flexible-dose multicenter trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Sertraline in the treatment of panic disorder. A multi-site, double-blind, placebo-controlled, fixed-dose investigation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Adverse events in users of sertraline: results from an observational study in psychiatric practice in The Netherlands. [2022]

8. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

Sertraline and alprazolam in the treatment of panic desorder. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy of sertraline in severe generalized social anxiety disorder: results of a double-blind, placebo-controlled study. [2022]

10. Spain pubmed.ncbi.nlm.nih.gov

Sertraline in the treatment of panic disorder. [2022]