Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation
Recruiting · NCT06763081 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Manitoba
View the official record on ClinicalTrials.gov →Interventions studied
Not applicable- observational study
What this trial is about
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 can take part
Age range
6 Years to 24 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
2 locations listed.
- Shared Health Facilities - Winnipeg, Manitoba, Canada
- University of Manitoba College of Pharmacy - Winnipeg, Manitoba, Canada