Identifying genetic factors in children affected by antidepressant side effects
Pharmacogenetics of Antidepressant-Induced Disinhibition in Children Study
This study is trying to find out if certain genes can help predict which children might have negative side effects from antidepressants, so doctors can better manage their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT03953014 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify pharmacogenetic profiles linked to behavioral disinhibition caused by selective serotonin reuptake inhibitors (SSRIs) in children diagnosed with major depressive disorder, anxiety disorders, or obsessive-compulsive disorder. By analyzing medical records and genetic samples from 120 children aged 6 to 17 who have undergone SSRI treatment, the study seeks to determine if there are distinct genetic markers that predict adverse behavioral reactions. The goal is to develop clinical tools that can help healthcare providers anticipate and mitigate these side effects, ultimately improving treatment outcomes for affected children.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 17 with a diagnosis of major depressive disorder, anxiety disorders, or obsessive-compulsive disorder who have a history of SSRI therapy.
Not a fit: Patients with attention deficit hyperactivity disorder, oppositional defiant disorder, conduct disorder, bipolar disorder, psychotic disorder, or pervasive developmental disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies that minimize adverse reactions to SSRIs in children.
How similar studies have performed: While the approach of identifying pharmacogenetic profiles is gaining traction, this specific study is novel in its focus on SSRI-induced behavioral disinhibition in children.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Calgary, Alberta
- Child and Adolescent Addiction, Mental Health & Psychiatry — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Chad Bousman, PhD — University of Calgary
- Study coordinator: Madison Heintz, MSW
- Email: psychpgxlab@ucalgary.ca
- Phone: 5875739747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.