NCT06763081 Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation
| NCT ID | NCT06763081 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Manitoba |
| Condition | Behavioral Activation |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2025-03-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06763081 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 24 Years, studying Behavioral Activation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06763081 currently recruiting?
Yes, NCT06763081 is actively recruiting participants. Contact the research team at abdullah.maruf@umanitoba.ca for enrollment information.
Where is the NCT06763081 trial being conducted?
This trial is being conducted at Winnipeg, Canada, Winnipeg, Canada.
Who is sponsoring the NCT06763081 clinical trial?
NCT06763081 is sponsored by University of Manitoba. The trial plans to enroll 160 participants.