Pharmacogenetics of Antidepressant-Induced Disinhibition (PGx-AID)
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|ClinicalTrials.gov Identifier: NCT03953014|
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
|Condition or disease|
|Obsessive-Compulsive Disorder Anxiety Disorders Major Depressive Disorder Antidepressant Drug Adverse Reaction|
Background and Rationale:
Antidepressants such as serotonin-selective reuptake inhibitors (SSRIs) are frequently prescribed to children to manage major depressive and anxiety disorders. Although SSRIs are thought to be generally effective and well-tolerated in children, 10%- 20% of children treated with SSRIs experience behavioral disinhibition (i.e. activation, hyperactivity, impulsivity, insomnia) that can lead to devastating consequences (e.g. suicidal impulses, violence). There are currently no tools available to assist healthcare providers in predicting which children will experience behavioral disinhibition as a result of SSRI treatment.
Do children who experience SSRI-induced behavioral disinhibition (SIBD) have a distinct pharmacogenetic profile relative to children who do not have these adverse experiences?
Using a retrospective cohort study design, 120 SSRI-treated children diagnose with major depression, anxiety and OCD, aged 6 to 17 years of aged will be recruited from Child and Adolescent Addiction, Mental Health & Psychiatry (CAAMHP) Program in Calgary. Children with a current or past history of SSRI use will be identified via recruitment advertisements and by CAAMHP treatment teams operating within community clinics as well as inpatient units within the Alberta Children's Hospital and Foothills Medical Centre.
Clinical data will be collected from the participant's medical record as well as information provided by the child's healthcare provider and caretaker using a customized data collection form. Saliva will be collected, processed and genotyped in accordance with standard procedures. Participants and their parents will complete self-report measures to gather information regarding demographics, SIBD, and other adverse side effects and drug reactions.
Using machine learning (i.e. the construction of algorithms that can learn from and make predictions on data) we will identify and validate a panel of genetic variants that could be used to pre-emptively detect children at-risk for developing SSRI-induced behavioral disinhibition.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Pharmacogenetics of Antidepressant-Induced Disinhibition in Children Study|
|Actual Study Start Date :||January 2, 2019|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||August 31, 2022|
- Genetic variants in SSRI metabolism [ Time Frame: 4 years ]DNA Sample Collection & Genotyping. Saliva will be collected using Oragene® collection tubes (DNA Genotek, Ottawa, Canada). DNA will be extracted using standard procedures and genotyped.
- Behavioural Disinhibition [ Time Frame: 4 years ]
Information on behavioural disinhibition (BD) to note the type, duration and severity of BD gathered from medical records, and participant and parent report.
The Treatment-emergent activation and suicidality assessment profile (TEASAP), is a questionnaire that assess common symptoms of activation syndrome/behavioural disinhibition in youth due to SSRI usage.
- Adverse Drug Reactions other than SIBD [ Time Frame: 4 years ]A self-report instrument, The Antidepressant Side-Effect Checklist (ASEC) will be used to assess the presence of common adverse reactions to antidepressants.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953014
|Contact: Camilia Thieba, MScfirstname.lastname@example.org|
|Contact: Abdullah Al Maruf, PhDemail@example.com|
|Child and Adolescent Addiction, Mental Health & Psychiatry||Recruiting|
|Calgary, Alberta, Canada|
|Contact: Camilia Theiba, MSc|
|Principal Investigator: Chad Bousman, PhD|
|Principal Investigator: Paul Arnold, MD|
|Principal Investigator:||Chad Bousman, PhD||University of Calgary|
|Principal Investigator:||Paul Arnold, MD||University of Calgary|