Sertraline for Anxiety Disorders
(EV-SoPRANO Trial)
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
45678How 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.
345910Eligibility 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.
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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.
+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
Participant Groups
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.
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
Sertraline is already approved in United States, European Union for the following indications:
๐บ๐ธ 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
๐ช๐บ 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of CincinnatiCincinnati, OH
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Who Is Running the Clinical Trial?
University of CincinnatiLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Methodologies and outcomes from the sertraline multicenter flexible-dose trials. [2013]This article summarizes the results of a combined analysis from two identical multicenter clinical trials that investigated the efficacy and safety of sertraline versus placebo for treating panic disorder. Patients with panic disorder who were treated with sertraline had a statistically significant reduction in the mean number of panic attacks per week (the primary efficacy measure) as compared with placebo (4.8 vs. 2.5, p
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]This study is the first to investigate the relative effectiveness of cognitive-behavioral therapy (CBT) compared with a selective serotonin reuptake inhibitor (SSRI; sertraline) in a randomized, controlled trial on the treatment of anxiety disorders in older adults.
Sertraline in the treatment of anxiety disorders. [2022]Sertraline was first developed and approved for the treatment of depression. However, considerable research has been conducted on its use in anxiety disorders. This paper reviews the data emerging from controlled and open trials of the use of sertraline in anxiety disorders. Sertraline has been tested extensively in the treatment of panic and obsessive-compulsive disorders. Less extensive testing has been completed on social phobia and post-traumatic stress disorder. The reviewed studies show that sertraline is an effective and well-tolerated treatment of all of these disorders. A comparison of sertraline with other pharmacotherapeutic options shows it to be at least equivalent to other medications for anxiety disorders.
Coadministration of sertraline with cisapride or pimozide: an open-label, nonrandomized examination of pharmacokinetics and corrected QT intervals in healthy adult volunteers. [2022]Sertraline hydrochloride is a selective serotonin reuptake inhibitor with demonstrated efficacy and safety for the treatment of the following disorders: major depressive, obsessive-compulsive, panic, premenstrual dysphoric, social anxiety, and posttraumatic stress. Although sertraline is unlikely to cause clinically significant inhibition of cytochrome P450 (CYP) 3A4 substrates, even modest concentration increases for narrow therapeutic index drugs, such as pimozide or cisapride, are potentially important.
Sertraline in the treatment of panic disorder: a flexible-dose multicenter trial. [2022]The serotonin selective reuptake inhibitors are increasingly being used for the treatment of panic disorder. We examined the efficacy and safety of the serotonin selective reuptake inhibitor sertraline hydrochloride in patients with panic disorder.
Sertraline in the treatment of panic disorder. A multi-site, double-blind, placebo-controlled, fixed-dose investigation. [2022]This study compared the efficacy and safety of sertraline to placebo in treating panic disorder.
Adverse events in users of sertraline: results from an observational study in psychiatric practice in The Netherlands. [2022]To evaluate the safety profile of sertraline versus other Selective Serotonin Reuptake Inhibitors (SSRIs) directly following the introduction of sertraline to the Dutch market.
Sertraline and alprazolam in the treatment of panic desorder. [2022]A compared, 12 week, placebo controlled study, with fixed dose, outpatient study of patients diagnosed with panic disorder with and without agoraphobia according to ICD-10, was conducted to evaluate the efficacy and safety of sertraline and alprazolam. The study included 40 patients, divided in two groups. We evaluated number of ICD-10-defined panic attacks, agoraphobia and anticipatory anxiety. All patients were aged 18 year and older and were randomized to either sertraline or alprazolam. Sertraline applied in fixed doses of 20 mg/day and alprazolam in doses 1-1,5 mg/day significantly reduced the frequency of panic attacks in panic disorder patients, reduced symptoms of agoraphobia and anticipatory anxiety.
Efficacy of sertraline in severe generalized social anxiety disorder: results of a double-blind, placebo-controlled study. [2022]Generalized social anxiety disorder is an early onset, highly chronic, frequently disabling disorder with a lifetime prevalence of approximately 13%. The goal of the current study was to evaluate the efficacy and tolerability of sertraline for the treatment of severe generalized social anxiety disorder in adults.
Sertraline in the treatment of panic disorder. [2022]Sertraline has been used as a treatment for anxiety disorders since the mid 1990s and has proven itself an effective, well-tolerated and economically viable treatment for panic disorder (PD) when used in the range of 50 to 175 mg per day. Numerous short- and long-term studies have demonstrated the efficacy of sertraline in the treatment of PD. In addition, in an 80-week relapse prevention trial, sertraline was found to reduce severity and frequency of panic attacks, baseline anxiety and to confer protection from relapse for up to 36 weeks following withdrawal from medication Data on sertraline as an alternative to tricyclic antidepressants and paroxetine in terms of tolerability is presented here. The efficacy of sertraline is shown to be comparable to cognitive behavioral therapy in one study and recent attempts at adjunctive therapy for PD with atypical antipsychotics are reviewed as well. Anxiety disorders constitute the most prevalent grouping of mental illnesses in the general population. Patients with panic disorder suffer a significant degree of medical comorbidity in addition to overlap with major depressive disorder, generalized anxiety disorder and somatization disorders. Further, PD patients experience a high degree of debility as measured by public assistance, emergency room and medical service utilization and suicide risk. Epidemiological data and studies linking significant decrease in medical, emergency service and laboratory utilization in PD patients taking sertraline are also presented. When reviewed in context with the efficacy trials, a compelling argument can be made for making sertraline a first choice among the serotonin reuptake inhibitors in the treatment of PD.