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.
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
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
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.
Case-control
Prospective
Not applicable- observational study
Other interventionIt's an observational study. Participants are not assigned an intervention as part of the study.
Pharmacogenomics variants associated with SSRI-induced behavioural activation
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
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).
Effect of genetic variation on SSRI-Induced adverse effects
A self-report instrument, The Antidepressant Side-Effect Checklist (ASEC) will be used to compare the common adverse drug reactions to SSRI antidepressants in all participants.
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University of Manitoba
Lead sponsor
Health Sciences Centre Foundation, Manitoba
Collaborator
Children's Hospital Research Institute of Manitoba
Collaborator
University of Calgary
Collaborator
