Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
NCT ID: NCT06081348
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
130 participants
INTERVENTIONAL
2024-09-16
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sertraline
Sertraline
Oral capsule (25mg, 50mg, 100mg, 200mg)
Placebo
Placebo
Oral placebo capsule
Interventions
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Sertraline
Oral capsule (25mg, 50mg, 100mg, 200mg)
Placebo
Oral placebo capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
8 Years
17 Years
ALL
No
Sponsors
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Azrieli Foundation (Funder)
UNKNOWN
Canadian Institutes of Health Research (Funder)
UNKNOWN
Ontario Brain Institute (Funder)
UNKNOWN
McMaster University
OTHER
Western University
OTHER
Queen's University
OTHER
University of Alberta
OTHER
Alberta Health services
OTHER
St. Justine's Hospital
OTHER
Dalhousie University
OTHER
Unity Health Toronto
OTHER
University of Toronto
OTHER
The Hospital for Sick Children
OTHER
Maternal, Infant, Child and Youth Research Network (MICYRN)
UNKNOWN
Holland Bloorview Kids Rehabilitation Hospital
OTHER
Responsible Party
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Principal Investigators
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Dr. Evdokia Anagnostou
Role: PRINCIPAL_INVESTIGATOR
Holland Bloorview Kids Rehab Hospital
Locations
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Alberta Children's Hospital - University of Calgary
Calgary, Alberta, Canada
University of Alberta-Glenrose
Edmonton, Alberta, Canada
Dalhousie University - IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster University
Hamilton, Ontario, Canada
Queen's University
Kingston, Ontario, Canada
University of Western Ontario, Lawson Health Research Institute
London, Ontario, Canada
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada
Ste Justine Hospital - Universite de Montreal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Baudouin Forgeot D'Arc
Role: primary
Other Identifiers
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SER-11-2020
Identifier Type: -
Identifier Source: org_study_id
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