Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT03953014

Conditions

Obsessive-Compulsive Disorder

Anxiety Disorders

Major Depressive Disorder

Antidepressant Drug Adverse Reaction

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this study is to identify pharmacogenetic profiles associated with selective serotonin reuptake inhibitors (SSRI)-induced behavioral disinhibition in children with Major depressive disorder (MDD), anxiety disorders and/or obsessive-compulsive disorder (OCD) that could be used clinically to reduce the incidence of this adverse event and improve health outcomes.

Conditions

Obsessive-Compulsive Disorder

Anxiety Disorders

Major Depressive Disorder

Antidepressant Drug Adverse Reaction

Study ID

NCT03953014

Start date

Jan 2, 2019

Status verified date

May, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Aged 6 - 24 years
2. Medical records available
3. Diagnosis of MDD, anxiety disorder, or OCD
4. Current or past history of SSRI therapy

Exclusion Criteria:

1. Inability of parent/legal guardian to give informed consent
2. Inability of the child to give informed assent
3. Unwillingness of child to provide saliva sample for genetic analysis
4. Current, past or suspected diagnosis of attention deficit hyperactivity disorder, oppositional defiant disorder, conduct disorder, bipolar disorder, psychotic disorder, or pervasive developmental disorder.

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Genetic variants in SSRI metabolism [ Time Frame: 4 years ]
  • Behavioural Disinhibition [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Madison Heintz, MSW

5875739747psychpgxlab@ucalgary.ca

Abdullah Al Maruf, PhD

abdullahal.maruf@ucalgary.ca

Locations

Child and Adolescent Addiction, Mental Health & Psychiatry

Recruiting

Calgary, Alberta, Canada

Principal Investigator:

Chad Bousman, PhD

More Information

Sponsor

University of Calgary

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • SSRI
  • Depression
  • Children
  • OCD
  • Anxiety
  • Antidepressants

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 Calgary on 2026-05-14.