Behavioral ActivationPGx-SImBANCT06763081
Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation
An observational study of Behavioral Activation and Major Depressive Disorder, run by University of Manitoba at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 24 years
- Conditions the study is for
- Behavioral Activation, Major Depressive Disorder, Anxiety Disorders
- What is being tested?
- Not applicable- observational study
- How many people
- 160 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Mar 2025to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
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 and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Shared Health Facilities
Winnipeg, Manitoba, R3C 3H8
Abdullah Al Maruf, PhD, M.Pharm., B.Pharm, 204-318-2575, abdullah.maruf@umanitoba.ca
- Recruiting
University of Manitoba College of Pharmacy
Winnipeg, Manitoba, R3E 0T5
Abdullah Al Maruf, PhD, M.Pharm, B.Pharm, 204-318-2575, abdullah.maruf@umanitoba.ca
Mahin Hasan, MSc, BSc, hasanm33@myumanitoba.ca
About this study
Official title: Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation in Children and Youth (PGx-SImBA)
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.
Read the detailed description
Background and Rationale: 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 the most frequently prescribed medications for this population. Although SSRIs are generally effective and well-tolerated, some children and youth suffer from burdensome adverse effects. One such adverse effect is "behavioural activation", which is characterized by a rapid onset of hyperactivity, impulsivity, irritability, or insomnia that can lead to consequences such as violence and suicidal ideation. Collectively, this can impose a major burden on families as well as a substantial economic cost to society. Unfortunately, there are no clinically useful markers available to assist clinicians in predicting which children and youth will experience behavioural activation as a result of SSRI treatment. Given that the use of these medicines in Canada is steadily increasing, solutions to curb the incidence of SSRI-induced behavioural activation are needed. The proposed study provides one such solution by identifying genetic markers associated with this adverse event.
Objectives: The proposed study aims to identify and validate a panel of genetic markers associated with SSRI-induced behavioural activation in children and youth with MDD, anxiety disorders, or OCD that could ultimately be used clinically to reduce the incidence of this adverse event and improve health outcomes.
Methods: Children and youth (aged 24 years or younger) who developed (cases) or did not develop (controls) behavioural activation after taking an SSRI will be matched on age, sex, ethnicity, diagnosis, and the SSRI prescribed. One hundred participants (50 cases, 50 controls) will be recruited. Participants will be recruited from the Child and Adolescent Mental Health Program at the Health Sciences Centre, the Children's Hospital of Winnipeg, pediatric community clinics, and clinics currently participating in the Manitoba Primary Care Research Network. Saliva samples will be collected from these children and youth. DNA will be extracted and genotyped using a comprehensive pharmacogenomic array. Pharmacogenomic profiles of the two groups will be compared to identify a panel of genetic variants associated with SSRI-induced behavioural activation. Finally, the panel will be replicated using an independent cohort of children and youth with SSRI-induced behavioural activation from the University of Calgary.
Expected Outcomes: The study not only provides the opportunity to advance knowledge in a grossly understudied area but also directly addresses a clinical need that, if fulfilled, could drastically reduce the incidence of a potentially severe adverse event associated with the care of children and youth with MDD, anxiety disorders, and OCD. The study will provide an initial and crucial step for achieving this anticipated impact by enabling the discovery of pharmacogenomic markers that could then be taken forward and tested in prospective clinical trials and ultimately integrated into clinical practice.
- Conditions
- Behavioral Activation, Major Depressive Disorder, Anxiety Disorders, Antidepressant Drug Adverse Reaction, Obsessive Compulsive Disorder (OCD), Major Depression
- Being tested
- Not applicable- observational study
- 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
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders, Obsessive-Compulsive Disorder, Depression, Mood Disorders, Mental Disorders, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
It's an observational study. Participants are not assigned an intervention as part of the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline, at study enrollment
Secondary outcomes (1)
Effect of genetic variation on SSRI-Induced adverse effects
A self-report instrument, The Antidepressant Side-Effect Checklist (ASEC) will be used to compare the common adverse drug reactions to SSRI antidepressants in all participants.
Measured: Baseline, at study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral ActivationStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Health Sciences Centre Foundation, Manitoba, Children's Hospital Research Institute of Manitoba, University of Calgary
- Responsible party
- Principal investigator, Abdullah Al Maruf, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763081
- Sponsor's protocol ID
- HS26592 (H2024:248)
- Acronym
- PGx-SImBA
- Status last verified
- Sep 2025
- First submitted
- 24 Dec 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation in Children and Youth (PGx-SImBA)
- ClinicalTrials.gov ID
- NCT06763081
- Acronym / sponsor ID
- PGx-SImBA / HS26592 (H2024:248)
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Health Sciences Centre Foundation, Manitoba, Children's Hospital Research Institute of Manitoba, University of Calgary
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale: 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 the most frequently prescribed medications for this population. Although SSRIs are generally effective and well-tolerated, some children and youth suffer from burdensome adverse effects. One such adverse effect is "behavioural activation", which is characterized by a rapid onset of hyperactivity, impulsivity, irritability, or insomnia that can lead to consequences such as violence and suicidal ideation. Collectively, this can impose a major burden on families as well as a substantial economic cost to society. Unfortunately, there are no clinically useful markers available to assist clinicians in predicting which children and youth will experience behavioural activation as a result of SSRI treatment. Given that the use of these medicines in Canada is steadily increasing, solutions to curb the incidence of SSRI-induced behavioural activation are needed. The proposed study provides one such solution by identifying genetic markers associated with this adverse event.
Objectives: The proposed study aims to identify and validate a panel of genetic markers associated with SSRI-induced behavioural activation in children and youth with MDD, anxiety disorders, or OCD that could ultimately be used clinically to reduce the incidence of this adverse event and improve health outcomes.
Methods: Children and youth (aged 24 years or younger) who developed (cases) or did not develop (controls) behavioural activation after taking an SSRI will be matched on age, sex, ethnicity, diagnosis, and the SSRI prescribed. One hundred participants (50 cases, 50 controls) will be recruited. Participants will be recruited from the Child and Adolescent Mental Health Program at the Health Sciences Centre, the Children's Hospital of Winnipeg, pediatric community clinics, and clinics currently participating in the Manitoba Primary Care Research Network. Saliva samples will be collected from these children and youth. DNA will be extracted and genotyped using a comprehensive pharmacogenomic array. Pharmacogenomic profiles of the two groups will be compared to identify a panel of genetic variants associated with SSRI-induced behavioural activation. Finally, the panel will be replicated using an independent cohort of children and youth with SSRI-induced behavioural activation from the University of Calgary.
Expected Outcomes: The study not only provides the opportunity to advance knowledge in a grossly understudied area but also directly addresses a clinical need that, if fulfilled, could drastically reduce the incidence of a potentially severe adverse event associated with the care of children and youth with MDD, anxiety disorders, and OCD. The study will provide an initial and crucial step for achieving this anticipated impact by enabling the discovery of pharmacogenomic markers that could then be taken forward and tested in prospective clinical trials and ultimately integrated into clinical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyIt's an observational study. Participants are not assigned an intervention as part of the study. | Other | – |
Primary outcome
Pharmacogenomics variants associated with SSRI-induced behavioural activation
Time frame: Baseline, study-enrollment
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.
Assessment of behavioural activation
Time frame: Baseline, at study enrollment
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).
1 secondary outcome
Effect of genetic variation on SSRI-Induced adverse effects
Time frame: Baseline, at study enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavioral Activation and Major Depressive Disorder, run by University of Manitoba at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdullah A Maruf, BPharm, MPharm, PhD (204-318-2575, abdullah.maruf@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacogenomics variants associated with SSRI-induced behavioural activation (time frame: Baseline, study-enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.