Clinical Trials Logo
  1. Home
  2. Neurodevelopmental Disorders
  3. NCT06081348

Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders — CALM  

Anxiety Clinical Trial

Official title:
A Randomized Placebo-Controlled Trial of Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • 22Q11 Deletion Syndrome
  • ADHD
  • ADHD - Combined Type
  • ADHD Predominantly Inattentive Type
  • ADHD, Predominantly Hyperactive - Impulsive
  • Agoraphobia
  • Anxiety
  • Anxiety Disorders
  • Anxiety, Separation
  • Autism
  • Autism Spectrum Disorder
  • Autistic Disorder
  • DiGeorge Syndrome
  • Fragile X Syndrome
  • Generalized Anxiety
  • Generalized Anxiety Disorder
  • Neurodevelopmental Disorders
  • Phobia, Social
  • Provisional Tic Disorder
  • Separation Anxiety
  • Social Anxiety
  • Social Anxiety Disorder
  • Syndrome
  • Tic Disorders
  • Tics
  • Tourette Syndrome
  • Tourette Syndrome in Adolescence
  • Tourette Syndrome in Children
  • Tuberous Sclerosis
Clinical Trial Details
NCT number NCT06081348
Study type Interventional
Source Anagnostou, Evdokia, M.D.
Contact Karly Janisse
Phone 4164256220
Email kjanisse@hollandbloorview.ca
Status Not yet recruiting
Phase Phase 2
Start date October 2023
Completion date April 2024
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Active, not recruiting NCT04961112 - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits N/A
Terminated NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Completed NCT05980845 - The Effect Nature Sounds and Music on Hemodialysis Patients N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Completed NCT05585749 - Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients N/A
Terminated NCT03272555 - WILD 5 Wellness: A 30-Day Intervention N/A
Recruiting NCT05997849 - Development of a Multiplatform Mental Health Mobile Tool N/A
Completed NCT06421233 - The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels N/A