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Sertraline for Anxiety in Neurodevelopmental Disorders (CALM Trial)

Phase 2
Recruiting
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
Must not have
Received more than 2 previous appropriate trials of SSRIs with no adequate response
Known congenital QT prolongation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I've tried at least two SSRIs without success.
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I have a known genetic heart condition that affects my heart's rhythm.
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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.
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I cannot swallow capsules.
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I am not pregnant or I use reliable birth control methods.
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I am not taking Monoamine Oxidase Inhibitors or pimozide.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Screen for Child Anxiety Related Emotional Disorders (SCARED) - parent version
Secondary study objectives
Adverse events
Clinical Global Impressions - Improvement Scale - Global (CGI-I)
Clinical Global Impressions- Improvement Scale (CGI-I) focused on anxiety
+2 more
Other study objectives
Anxiety Depression and Mood Scale (ADAMS)
Clinical Global Impressions - Severity Scale - Global (CGI-S) focused on anxiety
Multidimensional Anxiety Scale for Children - 2nd addition (MASC-2)
+3 more

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
719 Previous Clinical Trials
1,042,422 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
549 Patients Enrolled for Autism Spectrum Disorder
The Hospital for Sick ChildrenOTHER
710 Previous Clinical Trials
6,958,066 Total Patients Enrolled
8 Trials studying Autism Spectrum Disorder
260 Patients Enrolled for Autism Spectrum Disorder
Dalhousie UniversityOTHER
173 Previous Clinical Trials
401,724 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
270 Patients Enrolled for Autism Spectrum Disorder
~87 spots leftby Mar 2026
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