Health TrialsbyHealthPanel

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

ConditionsNeurodevelopmental DisordersAutismAutism Spectrum DisorderFragile X SyndromeTuberous Sclerosis22Q11 Deletion Syndrome22Q11 DeletionADHDTic DisordersTourette SyndromeTourette Syndrome in ChildrenTourette Syndrome in AdolescenceADHD - Combined TypeADHD Predominantly Inattentive TypeADHD, Predominantly Hyperactive - ImpulsiveAnxietyAnxiety Disorders
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-17
SponsorHolland Bloorview Kids Rehabilitation Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Outpatients 8-17 years of age, inclusive

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.

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.

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.

Disqualifiers

Receiving other SSRIs within four weeks of randomization (6 weeks for fluoxetine)

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.

Received more than 2 previous appropriate trials of SSRIs with no adequate response

Pregnant females or sexually active females on inadequate contraception

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sertraline

    Drug

    Oral capsule (25mg, 50mg, 100mg, 200mg)

  • Placebo

    Other intervention

    Oral placebo capsule

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: SertralineActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The Screen for Child Anxiety Related Emotional Disorders (SCARED) - parent version

The SCARED is a 41-item measure of anxiety symptoms, with both child and parent versions. The parent version will be used as a primary outcome measure. The minimum overall score is 0 while the maximum overall score is 82. A score greater than or equal to 25 may indicate the presence of an Anxiety Disorder. Higher scores indicate a higher instance of anxiety symptoms while a lower score indicates a lower instance of anxiety symptoms.

Time frame
16 weeks

Secondary outcomes

1

Clinical Global Impressions - Improvement Scale - Global (CGI-I)

The CGI-I is a clinician reported scale which will be used to examine the effect of sertraline vs. placebo on measures of global function. The CGI-Improvement Scale employs a seven point (1 = very much improved to 7 = very much worse) to determine the participant's improvement in response to treatment.

Time frame
16 weeks
2

Adverse events

Adverse events as elicited by the SMURF.

Time frame
16 weeks
3

Pediatric Quality of Life Inventory (PedsQL)

The PedsQL will be used to examine the effect of sertraline vs. placebo on measures of quality of life. The PedsQL is measuring health-related quality of life (HRQOL) in 2- to 18-year-olds. The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent-proxy report scales that have been used extensively as an outcome measure, including in ASD. We will use the parent-proxy report scale, and optionally, age-appropriate child self-report scale. Each item is is rated between a 0 (Never a problem) to 4 (Almost always a problem).

Time frame
16 weeks
4

Whole blood serotonin (5-HT) assessment

A whole blood serotonin assessment will be completed to examine the effect of sertraline vs. placebo on biomarkers of serotonin. 3mL of blood will be drawn at screening and week 16 visits for the purpose of this assessment. High performance liquid chromatography will be performed using fluorometric detection of 5-HT, tryptophan (TRP), and 5-hydroxyindole acetic acid (5-HIAA), using N-methylserotonin as an internal standard. Using this method, 5-HT intra- and inter- assay coefficients of variation are reliably less than 5% and 10%, respectively.

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Holland Bloorview Kids Rehabilitation Hospital

Lead sponsor

Azrieli Foundation (Funder)

Collaborator

Canadian Institutes of Health Research (Funder)

Collaborator

Ontario Brain Institute (Funder)

Collaborator

McMaster University

Collaborator

Western University

Collaborator

Queen's University

Collaborator

University of Alberta

Collaborator

Alberta Health services

Collaborator

St. Justine's Hospital

Collaborator

Dalhousie University

Collaborator

Unity Health Toronto

Collaborator

University of Toronto

Collaborator

The Hospital for Sick Children

Collaborator

Maternal, Infant, Child and Youth Research Network (MICYRN)

Collaborator

Source ClinicalTrials.gov
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