Sertraline for Anxiety Disorders

(EV-SoPRANO Trial)

Overseen By Heidi K Schroeder

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests sertraline, a medication, to determine its effectiveness in helping children and teens with anxiety disorders. Researchers aim to compare its effects to a placebo (a pill with no active medicine) and observe healthy participants without anxiety. The goal is to determine if sertraline can reduce anxiety symptoms, such as constant worry or fear. Children and teens diagnosed with generalized, social, or separation anxiety who frequently experience anxiety issues might be suitable for this study. As a Phase 4 trial, sertraline is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

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 is the safety track record for sertraline?

Research shows that sertraline is generally well-tolerated. This medication often treats depression, anxiety, and OCD. In studies, most people taking sertraline report only mild side effects, such as nausea, dizziness, or dry mouth, while serious side effects are rare.

The FDA has approved sertraline for several conditions due to its strong safety record. Extensive research supports its safety for long-term use. In one study on anxiety, sertraline reduced anxiety symptoms and improved mental health.

While all medications can have side effects, sertraline's long history of use provides doctors with valuable safety information. Most people taking sertraline do not experience serious problems, making it a reliable choice for treating anxiety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Sertraline is unique because it specifically targets anxiety disorders by increasing serotonin levels in the brain, which can improve mood and reduce anxiety symptoms. Unlike some treatments that may take longer to become effective, sertraline typically starts to show benefits within a few weeks. Researchers are excited about sertraline because it has the potential to offer a more rapid relief from anxiety symptoms compared to other options, with a well-established safety profile from its use in treating depression.

What is the effectiveness track record for sertraline in treating anxiety disorders?

Research has shown that sertraline can effectively reduce anxiety symptoms. In one study, patients noticed improvements in their mental health within just six weeks of starting the medication. Sertraline is already a well-known treatment for conditions like major depression and panic disorder. It is safe and generally well-tolerated by patients. In this trial, participants will receive either sertraline or a placebo at random. This will allow researchers to further explore how sertraline can help with anxiety disorders, building on evidence that it can manage these symptoms. ^{1 2 4 6 7}

Who Is on the Research Team?

Jeffrey R Strawn, MD, FAACAP

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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 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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7029306/

The clinical effectiveness of sertraline in primary care and the ... Sertraline leads to reduced anxiety symptoms and self-reported improvements in mental health within 6 weeks, but any effect on depressive ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK547689/

Sertraline - StatPearls - NCBI Bookshelf - NIH Sertraline is a medication used to manage and treat the major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress ...

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2016/019839s74s86s87_20990s35s44s45lbl.pdf

ZOLOFT (sertraline hydrochloride) Label - accessdata.fda.gov Efficacy of ZOLOFT was established in the following trials: • MDD: two short-term trials and one maintenance trials in adults [See Clinical Studies (14.1)]. • ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0165178123003414

Selection of the optimal dose of sertraline for depression: A ... Studies have shown that sertraline significantly reduces the Hamilton Depression Rating Scale (HAM-D) scores compared with placebo in the treatment of patients ...

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/204431

Sertraline in the Treatment of Panic Disorder The results of this study indicate that sertraline is an effective, safe, and well-tolerated treatment for patients with panic disorder, with or without ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/sertraline-oral-route/description/drg-20065940

Sertraline (oral route) - Side effects & dosage Sertraline is used to treat depression, obsessive-compulsive disorder (OCD), panic disorder, premenstrual dysphoric disorder (PMDD), posttraumatic stress ...

7. drugs.com drugs.com/sertraline.html

Sertraline: Side Effects, Uses, and Dosage Sertraline (Zoloft) is an SSRI used to treat depression, anxiety, OCD, PTSD, and PMDD by increasing serotonin levels to improve mood and ...