PGx-SImBA
Please click on the link to participate (aged 6 - 24 years): https://redcap.link/pgxsimba
Major depressive disorder (MDD), anxiety disorders, and obsessive-compulsive disorder (OCD) are among the most common mental health disorders in children and youth. Antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), are frequently prescribed for these children and youth. Although these medications are generally effective and safe, some children suffer from behavioural adverse effects. One such adverse effect is behavioural activation, characterized by hyperactivity, impulsivity, or irritability. Unfortunately, we do not currently know why some children and youth develop behavioural adverse effects while others do not. The proposed project aims to identify a panel of genetic variants that could assist clinicians in detecting children and youth at-risk for developing these adverse effects.
Objectives:
The proposed study aims to identify a panel of genetic markers associated with SSRI-induced behavioural adverse effects in children and youth with MDD, anxiety disorders, or OCD that could ultimately be used clinically to reduce the incidence of these adverse events and improve health outcomes.
Inclusion criteria:
Exclusion criteria:
Please click on the link to participate: https://redcap.link/pgxsimba
ClinicalTrials.gov ID: NCT06763081
This study has been approved by the Health Research Ethics Board [RITHIM/CHIPER] (HS26592(H2024:248) and Shared Health Research and Innovation (SH2024:130).
Major depressive disorder (MDD), anxiety disorders, and obsessive-compulsive disorder (OCD) are among the most common mental health disorders in children and youth. Antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), are frequently prescribed for these children and youth. Although these medications are generally effective and safe, some children suffer from behavioural adverse effects. One such adverse effect is behavioural activation, characterized by hyperactivity, impulsivity, or irritability. Unfortunately, we do not currently know why some children and youth develop behavioural adverse effects while others do not. The proposed project aims to identify a panel of genetic variants that could assist clinicians in detecting children and youth at-risk for developing these adverse effects.
Objectives:
The proposed study aims to identify a panel of genetic markers associated with SSRI-induced behavioural adverse effects in children and youth with MDD, anxiety disorders, or OCD that could ultimately be used clinically to reduce the incidence of these adverse events and improve health outcomes.
Inclusion criteria:
- Resident of Manitoba, Canada
- 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) therapy, e.g., Citalopram [Celexa], Escitalopram [Cipralex], Fluoxetine [Prozac], Fluvoxamine [Luvox], Sertraline [Zoloft], Paroxetine [Paxil/Plaxil CR])
- Have experienced or did not experience any side effects after taking an SSRI
Exclusion criteria:
- Inability of parent/legal guardian/mature minors/youth to give informed consent
- Inability of the child (6 – 13 years) to give informed assent
- Unwillingness of the participant 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, or pervasive developmental disorder.
- History of liver or bone marrow (hematopoietic cell) transplant.
Please click on the link to participate: https://redcap.link/pgxsimba
ClinicalTrials.gov ID: NCT06763081
This study has been approved by the Health Research Ethics Board [RITHIM/CHIPER] (HS26592(H2024:248) and Shared Health Research and Innovation (SH2024:130).
Team:
Principal Investigator:
Abdullah Al Maruf, PhD, M.Pharm (University of Manitoba)
Co-Investigators/Collaborators:
Laurence Katz, MD, FRCPC (University of Manitoba)
Cara Katz, MD, FRCPC (University of Manitoba)
Geert ‘t Jong, MD, PhD (University of Manitoba)
Alexander Singer, MB BAO BCh, CCFP (University of Manitoba)
Jessica Hartley, MS, CGC (University of Manitoba)
Kaarina Kowalec, MSc, PhD (University of Manitoba)
Anna Chudyk, MSc, PhD (University of Manitoba)
Christine Leong, PharmD, MSc, PhD (University of Manitoba)
Terry Klassen, MD, MSc, FRCPC (University of Saskatchewan)
Chad Bousman, PhD, MPH (University of Calgary)
Paul Arnold, MD, PhD, FRCPC (University of Calgary)
Research Pharmacist:
Anju Sareen, BSc(Pharm), RPh (University of Manitoba)
Research Nurse:
Laina McAusland, RN, MSc (University of Calgary)
Clinical Research Coordinator:
Madison Heintz, MSW, RSW (University of Calgary)
Research Assistants:
Mahin Hasan, PhD student (University of Manitoba)
Nuzhat Tabassum, MSc Student (University of Manitoba)
Abdullah Al Maruf, PhD, M.Pharm (University of Manitoba)
Co-Investigators/Collaborators:
Laurence Katz, MD, FRCPC (University of Manitoba)
Cara Katz, MD, FRCPC (University of Manitoba)
Geert ‘t Jong, MD, PhD (University of Manitoba)
Alexander Singer, MB BAO BCh, CCFP (University of Manitoba)
Jessica Hartley, MS, CGC (University of Manitoba)
Kaarina Kowalec, MSc, PhD (University of Manitoba)
Anna Chudyk, MSc, PhD (University of Manitoba)
Christine Leong, PharmD, MSc, PhD (University of Manitoba)
Terry Klassen, MD, MSc, FRCPC (University of Saskatchewan)
Chad Bousman, PhD, MPH (University of Calgary)
Paul Arnold, MD, PhD, FRCPC (University of Calgary)
Research Pharmacist:
Anju Sareen, BSc(Pharm), RPh (University of Manitoba)
Research Nurse:
Laina McAusland, RN, MSc (University of Calgary)
Clinical Research Coordinator:
Madison Heintz, MSW, RSW (University of Calgary)
Research Assistants:
Mahin Hasan, PhD student (University of Manitoba)
Nuzhat Tabassum, MSc Student (University of Manitoba)
Recruitment materials are prepared by Grace. RedCap project is developed by Laina McAusland.
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