NCT06763081Recruiting
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)
Source: ClinicalTrials.gov · Last updated 8 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 160 (estimated)
- First submitted
- 24 Dec 2024
- Start date
- 1 Mar 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- University of Manitoba
- Diseases
- Depression
- NCT number
- NCT06763081
What you commit to
- Study type: Observational
- Planned participants: 160
- From 1 Mar 2025 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 6 years to 24 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Manitoba College of Pharmacy Coordinator of this site? Confirm its status | Winnipeg | Canada | Recruiting |
| Shared Health Facilities Coordinator of this site? Confirm its status | Winnipeg | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.