Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation

NCT06763081 | Recruiting

• 1 other identifier: HS26592 (H2024:248)
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Behavioral Activation; Major Depressive Disorder; Anxiety Disorders; Antidepressant Drug Adverse Reaction; Obsessive Compulsive Disorder (OCD); Major Depression

Keywords

SSRI; Depression; OCD; Anxiety; Antidepressants; Children; Adolescents; Mood Disorders; Drug-induced Adverse Events; Youth; Mental Illness; Mental disorders; Drug-Related Side Effects and Adverse Reactions; Selective Serotonin Reuptake Inhibitor; Disinhibition

Outcome Measures

Primary Outcomes (2)

• Pharmacogenomics variants associated with SSRI-induced behavioural activation

  DNA will be extracted from all participants at baseline using standard procedures and genotyped using the Infinium global diversity array (GDA) with an enhanced PGx array (Illumina Canada, Vancouver, Canada). Pharmacogenomic profiles (1,933,117 markers) of participants who developed (cases) or did not develop (controls) behavioural activation after taking an SSRI will be compared to identify a panel of genetic variants associated with SSRI-induced behavioural activation.

  Baseline, study-enrollment

• Assessment of behavioural activation

  To characterize and systematically assess SSRI-induced activation syndrome, all participants at baseline will be asked to complete a modified version of the Treatment-Emergent Activation and Suicidality Assessment Profile (TEASAP) scale with the help of their parents/guardians (informants).

  Baseline, at study enrollment

Secondary Outcomes (1)

• Effect of genetic variation on SSRI-Induced adverse effects

  Baseline, at study enrollment

Interventions

Not applicable- observational study OTHER

It's an observational study. Participants are not assigned an intervention as part of the study.

Eligibility Criteria

• Age: 6 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

SSRI-treated children and adolescents diagnosed with major depression, anxiety disorders, or OCD, aged 6 to 24 years, recruited from the Child and Adolescent Mental Health Program at the Health Sciences Centre, Manitoba Adolescent Treatment Centre, the Children's Hospital of Winnipeg, pediatric community clinics, and family health clinics in Manitoba, Canada.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• Health Sciences Centre Foundation, Manitoba: collaborator
• Children's Hospital Research Institute of Manitoba: collaborator
• University of Calgary Cumming School of Medicine: collaborator

Study Sites (2)

Shared Health Facilities

Winnipeg, Manitoba, R3C 3H8, Canada

RECRUITING

University of Manitoba College of Pharmacy

Winnipeg, Manitoba, R3E 0T5, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1 mL saliva sample. DNA will be extracted and biobanked.

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders; Obsessive-Compulsive Disorder; Depression; Mood Disorders; Mental Disorders; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Depressive Disorder; Behavioral Symptoms; Behavior; Chemically-Induced Disorders

Central Study Contacts

Abdullah A Maruf, BPharm, MPharm, PhD

CONTACT

204-318-2575; abdullah.maruf@umanitoba.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 8, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)