Trial Title:
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
NCT ID:
NCT06081348
Condition:
Neurodevelopmental Disorders
Autism
Autism Spectrum Disorder
Fragile X Syndrome
Tuberous Sclerosis
22Q11 Deletion Syndrome
22Q11 Deletion
ADHD
Tic Disorders
Tourette Syndrome
Tourette Syndrome in Children
Tourette Syndrome in Adolescence
ADHD - Combined Type
ADHD Predominantly Inattentive Type
ADHD, Predominantly Hyperactive - Impulsive
Anxiety
Anxiety Disorders
Conditions: Official terms:
Tuberous Sclerosis
DiGeorge Syndrome
22q11 Deletion Syndrome
Tourette Syndrome
Fragile X Syndrome
Tic Disorders
Syndrome
Anxiety Disorders
Autistic Disorder
Autism Spectrum Disorder
Neurodevelopmental Disorders
Sertraline
Selective Serotonin Reuptake Inhibitors
Serotonin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Sertraline
Description:
Oral capsule (25mg, 50mg, 100mg, 200mg)
Arm group label:
Sertraline
Other name:
Sertraline Hydrochloride
Other name:
Zoloft
Other name:
Serotonin Reuptake Inhibitor
Intervention type:
Other
Intervention name:
Placebo
Description:
Oral placebo capsule
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Outpatients 8-17 years of age, inclusive
2. Females of child bearing 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.
3. Meet Diagnostic and Statistical Manual of Mental Disorders - DSM-5 criteria for ASD,
ADHD, Tic Disorders, or genetic diagnosis of Fragile X, tuberous sclerosis or 22q11
deletions.
4. 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.
5. Have a Clinician's Global Impression-Severity for anxiety (CGI-S; Guy, 1976)) score
≥ 4 (moderately ill) (inter-rater reliability will be done prior to initiation of
enrollment, using videotapes of interviews and vignettes)
6. Have at least phrase speech, to allow for some self-report. So that results can be
generalized to children and youth with NDD and various levels of ability, no IQ
cut-off will be employed. Full-scale IQ (as measured by the Stanford-Binet) is
measured to explore its effect on efficacy and safety*
7. If already receiving interventions, must meet the following criteria:
1. If receiving concomitant medications affecting behaviour, must be on a stable
dose during the month prior to screening and will not electively modify ongoing
medications for study duration
2. If already receiving stable non-pharmacological behavioural interventions, have
stable participation during 3 months prior to screening, and will not
electively modify ongoing interventions
8. Ability to complete assessments in English/French
Exclusion Criteria:
1. Receiving other SSRIs within four weeks of randomization (6 weeks for fluoxetine)
2. Previous treatment with sertraline, at an adequate dose (at least 100mg for 6 weeks,
or lower dose and duration if not well-tolerated), associated with no response or
significant-to-the-participant side effects.
3. Received more than 2 previous appropriate trials of SSRIs with no adequate response
4. Pregnant females or sexually active females on inadequate contraception
5. Serious medical condition that, based on Investigator judgment, might interfere with
the conduct of the study, confound interpretation of the study results, or endanger
participant. In addition diabetic patients on medications for glycemic control will
be excluded as sertraline may interfere with glycemic control.
6. Hypersensitivity to sertraline or any components of its formulation
7. On Monoamine Oxidase Inhibitors or pimozide (as per product monograph)
8. On concomitant medications known to significantly increase QT interval where this
would result in unacceptable risk per Investigator judgment.
9. Known congenital QT prolongation
10. HIV, hepatitis B or C, hemophilia, abnormal blood pressure, substance abuse,
immunity disorder, major depressive episode or psychosis (as required by Health
Canada)
11. Unable to tolerate venipuncture
12. Unable to swallow capsules
13. Enrolled in another intervention study
Gender:
All
Minimum age:
8 Years
Maximum age:
17 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Alberta Children's Hospital - University of Calgary
Address:
City:
Calgary
Country:
Canada
Facility:
Name:
University of Alberta-Glenrose
Address:
City:
Edmonton
Country:
Canada
Facility:
Name:
Dalhousie University - IWK Health Centre
Address:
City:
Halifax
Country:
Canada
Facility:
Name:
McMaster University
Address:
City:
Hamilton
Zip:
L8S4K1
Country:
Canada
Facility:
Name:
Queen's University
Address:
City:
Kingston
Zip:
K7M8A6
Country:
Canada
Facility:
Name:
University of Western Ontario, Lawson Health Research Institute
Address:
City:
London
Zip:
N6A 5W9
Country:
Canada
Facility:
Name:
Ste Justine Hospital - Universite de Montreal
Address:
City:
Montréal
Country:
Canada
Start date:
June 10, 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Anagnostou, Evdokia, M.D.
Agency class:
Other
Collaborator:
Agency:
Azrieli Foundation (Funder)
Agency class:
Other
Collaborator:
Agency:
Canadian Institutes of Health Research (Funder)
Agency class:
Other
Collaborator:
Agency:
Ontario Brain Institute (Funder)
Agency class:
Other
Collaborator:
Agency:
Holland Bloorview Kids Rehabilitation Hospital
Agency class:
Other
Collaborator:
Agency:
McMaster University
Agency class:
Other
Collaborator:
Agency:
Western University
Agency class:
Other
Collaborator:
Agency:
Queen's University
Agency class:
Other
Collaborator:
Agency:
University of Alberta
Agency class:
Other
Collaborator:
Agency:
Alberta Health services
Agency class:
Other
Collaborator:
Agency:
St. Justine's Hospital
Agency class:
Other
Collaborator:
Agency:
Dalhousie University
Agency class:
Other
Collaborator:
Agency:
Unity Health Toronto
Agency class:
Other
Collaborator:
Agency:
University of Toronto
Agency class:
Other
Collaborator:
Agency:
The Hospital for Sick Children
Agency class:
Other
Source:
Anagnostou, Evdokia, M.D.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06081348
