RECRUITINGOBSERVATIONAL
Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation
Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation in Children and Youth (PGx-SImBA)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify: 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
Who Should NOT Join This Trial: Participants will be excluded from participation if any of the following are true.
- Inability of parent/legal guardian/mature minors to give willing to sign a consent form
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
OTHER
Not applicable- observational study
It's an observational study. Participants are not assigned an intervention as part of the study.
Locations (2)
Shared Health Facilities
Winnipeg, Manitoba, Canada
University of Manitoba College of Pharmacy
Winnipeg, Manitoba, Canada