Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
Recruiting · 8 sites across 4 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Outpatients ages 8–17 (inclusive).
- •Females who can become pregnant and are sexually active must agree to use medically acceptable birth control during the study and for at least one week after the last dose.
- •Have a neurodevelopmental disorder diagnosis such as ASD, ADHD, Tic Disorders, or a genetic diagnosis like Fragile X, tuberous sclerosis, or 22q11 deletions.
- •Have an anxiety disorder diagnosis based on DSM-5 criteria (including separation anxiety, social anxiety, agoraphobia, generalized anxiety, unspecified anxiety, and other specified anxiety disorder).
- •Have anxiety that is at least “moderately ill” based on the CGI-S score (≥ 4).
🚫 You may not be able to join if…
- •Are taking another SSRI within 4 weeks of randomization (6 weeks for fluoxetine).
- •Have taken sertraline before at an adequate dose for at least 6 weeks (or lower dose/duration if not tolerated) and had no response or had significant side effects.
- •Have had more than 2 prior appropriate SSRI trials with no adequate response.
- •Are pregnant, or are sexually active females who cannot use adequate contraception.
- •Have certain safety issues (like serious medical conditions that could interfere with the study), diabetes on glycemic-control medication, or known problems related to sertraline/heart rhythm (for example, congenital QT prolongation or medications that significantly raise QT interval).
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 8–17
- ✓Have Anxiety
- !Some conditions may not be a fit: Depression
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT06081348 · Locations: Alberta · Nova Scotia · Ontario · Quebec