← Back to Search

Sertraline for Anxiety in Neurodevelopmental Disorders (CALM Trial)

Phase 2
Waitlist Available
Led By Evdokia Anagnostou
Research Sponsored by Anagnostou, Evdokia, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet DSM-5 criteria for one of the following anxiety disorders: Separation Anxiety Disorder, Social Anxiety Disorder, Agoraphobia, Generalized Anxiety Disorder, or Unspecified Anxiety Disorder, based on expert clinical interview, supported by the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS; Kaufman et al., 2016). Other specified anxiety disorder is included to account for youth with impairing anxiety symptoms who may not meet criteria for one of the other anxiety disorders
Females of childbearing potential who are sexually active and agree to use medically acceptable birth control throughout the study and at least one week post last dose of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

CALM Trial Summary

This trial seeks to determine if sertraline could help reduce anxiety in kids/youth with neurodevelopmental disorders. More research is needed to confirm its effectiveness.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Sertraline can cause side effects like digestive issues, changes in mood or behavior, headaches, sleep problems, and may affect growth rate or weight gain in children. Some might experience increased thoughts of suicide at the start of treatment.

CALM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with an anxiety disorder like separation, social anxiety, or agoraphobia.
Select...
I agree to use birth control during and for a week after the study ends.
Select...
I am between 8 and 17 years old.
Select...
My medication doses affecting my behavior have been stable for the last month and won't change during the study.

CALM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Screen for Child Anxiety Related Emotional Disorders (SCARED) - parent version
Secondary outcome measures
Clinical Global Impressions - Improvement Scale - Global (CGI-I)
Pediatric Quality of Life Inventory (PedsQL)
The Health Utilities Index-3 (HUI-3)
+2 more
Other outcome measures
Anxiety Depression and Mood Scale (ADAMS)
Clinical Global Impressions - Severity Scale - Global (CGI-S) focused on anxiety
Clinical Global Impressions- Improvement Scale (CGI-I) focused on anxiety
+4 more

CALM Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: SertralineActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of TorontoOTHER
690 Previous Clinical Trials
1,019,513 Total Patients Enrolled
5 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
735 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
The Hospital for Sick ChildrenOTHER
689 Previous Clinical Trials
6,945,291 Total Patients Enrolled
4 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
601 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Dalhousie UniversityOTHER
167 Previous Clinical Trials
403,008 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
116 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent does Sertraline pose a risk for those taking it?

"Our risk assessment of sertraline was a 2, since it is in the middle phase of clinical trials and has some evidence to support its safety but not efficacy."

Answered by AI

What criteria must participants meet to take part in this experiment?

"This clinical trial has a limited number of spots available and is seeking participants who meet the criteria for autism spectrum disorder, as well as are within the age range of 8 to 17. The study can accept up to 130 applicants."

Answered by AI

Are elderly patients eligible to participate in this clinical trial?

"This trial's admittance criteria specify that applicants must be between 8 and 17 years old. Also, clinicaltrials.gov has 964 trials for minors and 1584 studies targeting persons aged 65 or above."

Answered by AI

How many healthcare facilities have been enlisted to facilitate the implementation of this trial?

"This research is being conducted at seven different sites, which are located in Edmonton, Halifax and Hamilton along with four other locations. To reduce the burden of travel for potential participants, it may be best to choose the closest site when enrolling."

Answered by AI

Does the trial currently have spots open for participants?

"Clinicaltrials.gov data suggests that this medical experiment is not taking on any more patients, having been initially posted on October 1st 2023 and last updated 11 days later. Nevertheless, there are currently 2,661 other active trials looking for participants at the moment."

Answered by AI

Who else is applying?

What site did they apply to?
Queen's University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
2023. "Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06081348.
All > Mental Illness
~87 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top