Sertraline for Anxiety in Neurodevelopmental Disorders (CALM Trial)
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Anagnostou, Evdokia, M.D.
Prior Safety Data
Trial Summary
What is the purpose of this trial?There are currently no approved medications for the treatment of anxiety in children and youth with neurodevelopmental disorders (NDDs), both common and rare. Sertraline, a selective serotonin reuptake inhibitor, has extensive evidence to support its use in children's and youth with anxiety but not within NDDs. More research is needed to confirm whether or not sertraline could help improve anxiety in children and youth with common and rare neurodevelopmental conditions. This is a pilot study, in which we plan to estimate the effect size of reduction in anxiety of sertraline vs. placebo. across rare and common neurodevelopmental disorders, and determine the best measure(s) to be used as a primary transdiagnostic outcome measure of anxiety, as well as diagnosis specific measures in future, larger-scale clinical trials of anxiety in NDDs.
What data supports the effectiveness of the drug sertraline for anxiety in neurodevelopmental disorders?
Research shows that sertraline, a drug used to treat anxiety, has been effective in reducing symptoms of social anxiety and panic disorder in adults, as well as generalized anxiety disorder in children. In these studies, patients taking sertraline experienced significant improvements compared to those taking a placebo (a dummy treatment with no active drug).
127810How does the drug sertraline differ from other treatments for anxiety in neurodevelopmental disorders?
Sertraline is unique because it has been extensively tested and shown to be effective for various anxiety disorders, including panic and obsessive-compulsive disorders, and is well-tolerated in children without affecting cognitive functions. This makes it a promising option for anxiety in neurodevelopmental disorders, where standard treatments may not be well-established.
12346Is sertraline safe for humans?
Sertraline, also known as Zoloft, has been studied extensively and is generally considered safe and well-tolerated in both adults and children for various conditions, including anxiety and mood disorders. It has a good safety profile with low risk of serious side effects.
23579Will I have to stop taking my current medications?
If you are taking medications that affect behavior, you must be on a stable dose for at least a month before the trial and cannot change them during the study. You cannot be on other SSRIs (a type of antidepressant) within four weeks of starting the trial, and certain other medications are also not allowed. The protocol does not specify a complete stop of all current medications.
Eligibility Criteria
This trial is for children and adolescents aged 8-17 with neurodevelopmental disorders like ASD, ADHD, or genetic conditions such as Fragile X syndrome. They must have anxiety symptoms and be able to communicate in English/French. Participants should not have had more than two unsuccessful SSRI treatments or any previous adverse reactions to sertraline.Inclusion Criteria
I have been diagnosed with an anxiety disorder like separation, social anxiety, or agoraphobia.
I agree to use birth control during and for a week after the study ends.
I am between 8 and 17 years old.
My medication doses affecting my behavior have been stable for the last month and won't change during the study.
Exclusion Criteria
I've tried at least two SSRIs without success.
I have a known genetic heart condition that affects my heart's rhythm.
I do not have HIV, hepatitis B or C, hemophilia, abnormal blood pressure, substance abuse issues, an immunity disorder, or a history of major depression or psychosis.
I cannot swallow capsules.
I am not pregnant or I use reliable birth control methods.
I am not taking Monoamine Oxidase Inhibitors or pimozide.
Participant Groups
The study tests Sertraline, a medication thought to help with anxiety, against a placebo in kids with various neurodevelopmental issues. It aims to find out how effective Sertraline is and identify the best ways to measure its impact on anxiety across different conditions.
2Treatment groups
Active Control
Placebo Group
Group I: SertralineActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Holland Bloorview Kids Rehabilitation HospitalToronto, Canada
Alberta Children's Hospital - University of CalgaryCalgary, Canada
University of Alberta-GlenroseEdmonton, Canada
Dalhousie University - IWK Health CentreHalifax, Canada
More Trial Locations
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Who is running the clinical trial?
Anagnostou, Evdokia, M.D.Lead Sponsor
University of TorontoCollaborator
The Hospital for Sick ChildrenCollaborator
Dalhousie UniversityCollaborator
Unity Health TorontoCollaborator
St. Justine's HospitalCollaborator
Azrieli FoundationCollaborator
Canadian Institutes of Health Research (CIHR)Collaborator
Ontario Brain InstituteCollaborator
Holland Bloorview Kids Rehabilitation HospitalCollaborator
References
Sertraline in social phobia. [2019]Twenty-two patients meeting a primary DSM-III-R diagnosis of Social Phobia, entered a 12 week open trial of sertraline. Twenty patients completed at least 8 weeks of treatment. Sixteen patients (80%) were considered responders and 4 (20%) were considered non-responders. All measures of social anxiety and avoidance, depression and social functioning showed a statistically significant change from baseline to end point.
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
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.
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.
Sertraline in children and adolescents with social anxiety disorder: an open trial. [2013]The aim of this open-label study was to assess the therapeutic benefits, response pattern, and safety of sertraline in children with social anxiety disorder.
[Sertraline in child and adolescent psychiatry]. [2022]The aim of the study was to research the efficiency of sertraline (zoloft) in depressions, anxious states and obsessive-compulsive disorders. Diagnosis of the mental disorders was carried out according to ICD-10. 72 children (59 boys, 13 girls) aged 6-18 years were treated. There were 32 inpatients and 40 outpatients. Therapy with sertraline was performed during 8 weeks with a gradual increase (titration) and individual selection of the dose from 12.5 to 100 mg/day. During the therapy clinical observation was combined with the patients' examination using Hamilton Depression Scale and Hamilton Anxiety Scale (HAM-D and HAM-A), and a Clinical Global Impression Scale (CGI). It was established that sertraline was very effective and safe drug in children (it has no influence on cognitive functions, has neither myorelaxing or sedative effects). Activity of this drug is characterized by quick manifestation of thymoanaleptic and anxiolytic effects. It mild depressive states 50 mg/day is a significant dose; in more severe depressions and obsessive-compulsive disorders the dose in juveniles was to 100 mg, the duration of the therapy was more than 2 months.
Placebo-controlled trial of sertraline in the treatment of children with generalized anxiety disorder. [2022]The study compared the safety and efficacy of sertraline, a selective serotonin reuptake inhibitor, and placebo in the treatment of generalized anxiety disorder in children and adolescents.
Multidimensional effects of sertraline in social anxiety disorder. [2022]Clinical trials of social anxiety disorder (SAD) have largely focused on the effect of treatment on symptoms of fear and avoidance, while neglecting the third clinically relevant dimension, physiological arousal. Data were combined from two previously reported placebo-controlled trials of sertraline in the treatment of moderate-to-severe generalized SAD. Efficacy was evaluated using the Brief Social Phobia Scale (BSPS). Three hundred forty-six subjects were randomized to 12-13 weeks of treatment with sertraline and 273 subjects to placebo. Following treatment, significant improvement was noted in favor of sertraline on the full BSPS (P
An evidence-based review of the clinical use of sertraline in mood and anxiety disorders. [2022]Sertraline is a selective serotonin reuptake inhibitor that has been used and studied extensively throughout the world and found to be safe and well tolerated in numerous patient populations, including those with either psychiatric and/or medical comorbidities. Randomized clinical trials have shown that it is an effective treatment for depressive and anxiety disorders and its efficacy is unaffected by psychiatric comorbidity. In non-comorbid patients, sertraline is effective for the acute treatment of major depressive disorders and prevention of relapse or recurrence. It is effective for acute treatment and longer-term management of social anxiety disorder, posttraumatic stress disorder,panic disorder, and generalized anxiety disorder. In adults and in pediatric patients, it is an effective short-term and long-term treatment for obsessive compulsive disorder.Sertraline has a good tolerability profile and has low fatal toxicity. In summary, sertraline is as effective as other antidepressants over a wide range of indications but may offer tolerability benefits as well as efficacy in patients with psychiatric and/or medical comorbidities and certain subtypes of depression.
Remission after acute treatment in children and adolescents with anxiety disorders: findings from the CAMS. [2022]To report on remission rates in anxious youth who participated in the Child/Adolescent Anxiety Multimodal Study (CAMS). The CAMS, a multisite clinical trial, randomized 488 children and adolescents (ages 7-17 years; 79% Caucasian; 50% female) with separation, social, and/or generalized anxiety disorder to a 12-week treatment of sertraline (SRT), cognitive behavioral therapy (CBT), their combination (COMB), or clinical management with pill placebo (PBO).