Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation in Children and Youth (PGx-SImBA)
Genetics Study for Children on Antidepressants
Plain English Summary
Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation is a Not Applicable clinical trial sponsored by University of Manitoba studying Behavioral Activation, Major Depressive Disorder, Anxiety Disorders, Antidepressant Drug Adverse Reaction, Obsessive Compulsive Disorder (OCD), Major Depression. This study looks at how a child's genes might affect their response to common antidepressants (SSRIs). It's for children and young adults (ages 6-24) diagnosed with depression, anxiety, or OCD who are taking or have taken SSRIs. Participation involves providing a saliva sample for genetic testing and completing questionnaires about behavioral changes. There are no alternative treatments offered within this study; it is observational. The trial aims to enroll 160 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Children and young adults aged 6 to 24 years old. Must be a resident of Manitoba, Canada. Must have a diagnosis of depression, anxiety, or OCD. Must be currently taking or have previously taken SSRI medications. This trial is studying Behavioral Activation, Major Depressive Disorder, Anxiety Disorders, Antidepressant Drug Adverse Reaction, Obsessive Compulsive Disorder (OCD), Major Depression, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures will help identify specific genetic variations that are linked to behavioral activation when using SSRIs, which could guide doctors in choosing the right medication and do The specific primary outcome measures are: Pharmacogenomics variants associated with SSRI-induced behavioural activation (Baseline, study-enrollment); Assessment of behavioural activation (Baseline, at study enrollment). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aims to find genetic markers that predict if a child will experience behavioral activation side effects from SSRIs, potentially leading to safer and more effective treatment choices. This research targets Behavioral Activation, Major Depressive Disorder, Anxiety Disorders, Antidepressant Drug Adverse Reaction, Obsessive Compulsive Disorder (OCD), Major Depression, where improved treatment options are needed.
Investor Insight
This observational study focuses on a critical unmet need in pediatric mental health, potentially improving the safety profile of widely used antidepressants and offering a personalized medicine appro
Is This Trial Right for Me?
Ask your doctor if your child's specific genetic makeup might influence their response to SSRIs. Participation involves a simple saliva sample collection and answering questions about your child's behavior and medication history. The study is observational, meaning your child will continue their current treatment as prescribed by their doctor. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 160 participants
Interventions
- OTHER: Not applicable- observational study — It's an observational study. Participants are not assigned an intervention as part of the study.
Primary Outcomes
- Pharmacogenomics variants associated with SSRI-induced behavioural activation (Baseline, study-enrollment)
- Assessment of behavioural activation (Baseline, at study enrollment)
Secondary Outcomes
- Effect of genetic variation on SSRI-Induced adverse effects (Baseline, at study enrollment)
Full 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.
Trial Locations
- Shared Health Facilities, Winnipeg, Manitoba, Canada
- University of Manitoba College of Pharmacy, Winnipeg, Manitoba, Canada
Frequently Asked Questions
What is clinical trial NCT06763081?
NCT06763081 is a Not Applicable OBSERVATIONAL study titled "Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation." It is currently recruiting and is sponsored by University of Manitoba. The trial targets enrollment of 160 participants.
What conditions does NCT06763081 study?
This trial investigates treatments for Behavioral Activation, Major Depressive Disorder, Anxiety Disorders, Antidepressant Drug Adverse Reaction, Obsessive Compulsive Disorder (OCD), Major Depression. The primary condition under study is Behavioral Activation.
What treatments are being tested in NCT06763081?
The interventions being studied include: Not applicable- observational study (OTHER). It's an observational study. Participants are not assigned an intervention as part of the study.
What does Not Applicable mean for NCT06763081?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06763081?
This trial is currently "Recruiting." It started on 2025-03-01. The estimated completion date is 2030-12-31.
Who is sponsoring NCT06763081?
NCT06763081 is sponsored by University of Manitoba. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06763081?
The trial aims to enroll 160 participants. The trial is currently recruiting and accepting new participants.
How is NCT06763081 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06763081?
The primary outcome measures are: Pharmacogenomics variants associated with SSRI-induced behavioural activation (Baseline, study-enrollment); Assessment of behavioural activation (Baseline, at study enrollment). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06763081 being conducted?
This trial is being conducted at 2 sites, including Winnipeg, Manitoba (Canada).
Where can I find official information about NCT06763081?
The official record for NCT06763081 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06763081. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06763081 testing in simple terms?
This study looks at how a child's genes might affect their response to common antidepressants (SSRIs). It's for children and young adults (ages 6-24) diagnosed with depression, anxiety, or OCD who are taking or have taken SSRIs.
Why is this trial significant?
This trial aims to find genetic markers that predict if a child will experience behavioral activation side effects from SSRIs, potentially leading to safer and more effective treatment choices.
What are the potential risks of participating in NCT06763081?
The main risk is the potential for discomfort during saliva sample collection. There is a small risk of breach of privacy for genetic information, though strict protocols are in place to protect data. No direct health risks are associated with participation as it is an observational study and no new treatments are given. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06763081?
Ask your doctor if your child's specific genetic makeup might influence their response to SSRIs. Participation involves a simple saliva sample collection and answering questions about your child's behavior and medication history. The study is observational, meaning your child will continue their current treatment as prescribed by their doctor. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06763081 signal from an investment perspective?
This observational study focuses on a critical unmet need in pediatric mental health, potentially improving the safety profile of widely used antidepressants and offering a personalized medicine appro This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing a saliva sample for genetic testing and completing questionnaires about behavioral changes. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.