Identifying genetic markers for SSRI-induced behavioral activation in youth
Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation in Children and Youth (PGx-SImBA)
This study is trying to find genetic markers that can help predict which children and teens with depression or anxiety might experience increased energy or restlessness from taking certain antidepressants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 6 Years to 24 Years |
| Sex | All |
| Sponsor | University of Manitoba Academic / other |
| Locations | 2 sites (Winnipeg, Manitoba and 1 other locations) |
| Trial ID | NCT06763081 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify and validate genetic markers associated with behavioral activation caused by selective serotonin reuptake inhibitors (SSRIs) in children and adolescents diagnosed with major depressive disorder, anxiety disorders, or obsessive-compulsive disorder. By analyzing participants who have experienced adverse effects from SSRIs, the study seeks to develop clinically useful markers that can predict which patients are at risk for these side effects. The ultimate goal is to improve health outcomes and reduce the incidence of behavioral activation in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates include children and adolescents aged 6 to 17 years with a diagnosis of major depressive disorder, anxiety disorders, or obsessive-compulsive disorder who have a history of SSRI therapy.
Not a fit: Patients who have not taken SSRIs or do not have a diagnosis of the specified mental health disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment approaches that minimize adverse effects of SSRIs in children and adolescents.
How similar studies have performed: While there have been studies on SSRIs and genetic markers, this specific approach to identifying behavioral activation in youth is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Winnipeg, Manitoba and 1 other locations
- Shared Health Facilities — Winnipeg, Manitoba, Canada (Recruiting)
- University of Manitoba College of Pharmacy — Winnipeg, Manitoba, Canada (Recruiting)
Study contacts
- Study coordinator: Abdullah A Maruf, BPharm, MPharm, PhD
- Email: abdullah.maruf@umanitoba.ca
- Phone: 204-318-2575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.