Recruiting

SSRI

Sponsor:

University of Manitoba

Code:

NCT06763081

Conditions

Behavioral Activation

Major Depressive Disorder

Anxiety Disorders

Antidepressant Drug Adverse Reaction

Obsessive Compulsive Disorder (OCD)

Eligibility Criteria

Sex: All

Age: 6 - 24

Healthy Volunteers: Not accepted

Interventions

Not applicable- observational study

Study Details

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)

Study ID

NCT06763081

Start date

Mar 1, 2025

Status verified date

Sep, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 24

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Interventions

Not applicable- observational study

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

Primary outcome measure

  • Pharmacogenomics variants associated with SSRI-induced behavioural activation [ Time Frame: Baseline, study-enrollment ]
  • Assessment of behavioural activation [ Time Frame: Baseline, at study enrollment ]

Central Contacts and Locations

Central contacts

Abdullah A Maruf, BPharm, MPharm, PhD

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

Locations

Shared Health Facilities

Recruiting

Winnipeg, Manitoba, Canada, R3C 3H8

Contacts

Abdullah Al Maruf, PhD, M.Pharm., B.Pharm

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

University of Manitoba College of Pharmacy

Recruiting

Winnipeg, Manitoba, Canada, R3E 0T5

Contacts

Abdullah Al Maruf, PhD, M.Pharm, B.Pharm

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

Mahin Hasan, MSc, BSc

hasanm33@myumanitoba.ca

Principal Investigator:

Abdullah Al Maruf, PhD, M.Pharm, B.Pharm

More Information

Sponsor

University of Manitoba

Last update posted

Sep 8, 2025

Last verified

Sep, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2025-09-08.