Not applicable- observational study: It's an observational study. Participants are not assigned an intervention as part of the study.
Study summary
The purpose of this study is to identify and validate a panel of genetic markers associated with selective serotonin reuptake inhibitors (SSRI)-induced behavioural activation in children and youth with major depressive disorder (MDD), anxiety disorders, or obsessive-compulsive disorder (OCD) that could be used clinically to reduce the incidence of this adverse event and improve health outcomes.
Eligibility
Sex
ALL
Min age
6 Years
Max age
24 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Pharmacogenomics variants associated with SSRI-induced behavioural activation — Baseline, study-enrollment DNA will be extracted from all participants at baseline using standard procedures and genotyped using the Infinium global diversity array (GDA) with an enhanced PGx array (Illumina Canada, Vancouver, Canada). Pharmacogenomic profiles (1,933,117 markers) of participants who developed (cases) or did not develop (controls) behavioural activation after taking an SSRI will be compared to identify a panel of genetic variants associated with SSRI-induced behavioural activation.
Assessment of behavioural activation — Baseline, at study enrollment To characterize and systematically assess SSRI-induced activation syndrome, all participants at baseline will be asked to complete a modified version of the Treatment-Emergent Activation and Suicidality Assessment Profile (TEASAP) scale with the help of their parents/guardians (informants).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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