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Gene hunt aims to prevent SSRI agitation in children

NCT ID NCT06763081

Knowledge-focused Sponsor: University of Manitoba Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is looking for genetic markers linked to a side effect called behavioral activation—feeling overly excited or agitated—that can happen when children and youth take SSRI antidepressants for depression, anxiety, or OCD. Researchers will collect DNA from 160 participants aged 6 to 24 in Manitoba and compare those who had the side effect to those who didn't. The goal is to find a set of genes that could one day help doctors choose safer medications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors predict which kids might have bad side effects from common antidepressants, making treatment safer.
What could go wrong
This is an observational study, not a treatment trial. It may not find clear genetic markers, and results might not change practice for years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

SSRI-treated children and adolescents diagnosed with major depression, anxiety disorders, or OCD, aged 6 to 24 years, recruited from the Child and Adolescent Mental Health Program at the Health Sciences Centre, Manitoba Adolescent Treatment Centre, the Children's Hospital of Winnipeg, pediatric community clinics, and family health clinics in Manitoba, Canada.

Ages

6 to 24 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: Participants will be eligible for participation if all of the following are true. * Resident of Manitoba * Age, 6 - 24 years * Diagnosis of major depressive disorder (MDD), anxiety disorder, or obsessive-compulsive disorder (OCD) * Current or past history of selective serotonin reuptake inhibitor (SSRI), e.g., Citalopram \[Celexa\], Escitalopram \[Cipralex\], Fluoxetine \[Prozac\], Fluvoxamine \[Luvox\], Sertraline \[Zoloft\], Paroxetine \[Paxil/Plaxil CR\]) therapy * \[Cases Only\] Have experienced behavioural side effects after taking an SSRI that resolved after reducing the dose or discontinuation of the drug * \[Controls Only\] Did not experience any side effects after taking an SSRI for eight (8) continuous weeks Exclusion criteria: Participants will be excluded from participation if any of the following are true. * Inability of parent/legal guardian/mature minors to give informed consent * Inability of the child (6 - 13 years) to give informed assent * Unwillingness of the child to provide a saliva sample for genetic analysis * Current, past, or suspected diagnosis of attention deficit hyperactivity disorder (combined or hyperactive type), oppositional defiant disorder, conduct disorder, bipolar disorder, psychotic disorder, pervasive developmental disorder * History of liver or bone marrow (hematopoietic cell) transplant.

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Conditions

The condition(s) this trial relates to.

anxiety disorder Depression Drug-Related Side Effects and Adverse Reactions major depressive disorder mood disorder obsessive-compulsive disorder psychiatric disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antidepressant drug adverse reaction Anxiety disorders Behavioral activation Major depression Major depressive disorder Obsessive compulsive disorder (OCD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shared Health Facilities

    RECRUITING

    Winnipeg, Manitoba, R3C 3H8, Canada

  • University of Manitoba College of Pharmacy

    RECRUITING

    Winnipeg, Manitoba, R3E 0T5, Canada

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