NCT03953014|Recruiting
Pharmacogenetics of Antidepressant-Induced Disinhibition
PGx-AID
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PGx-AID
Sponsor study identifier
observational
120
1 country
1
Study Start
January 2, 2019
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2, 2019
Actual (reported)May 14, 2019
Actual (reported)May 16, 2019
Actual (reported)September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Genetic variants in SSRI metabolism
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.
4 years
Behavioural Disinhibition
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.
4 years
Adverse Drug Reactions other than SIBD
SSRI-treated children diagnosed with major depression, anxiety and OCD, aged 6 to 24 years recruited from the Child and Adolescent Addiction, Mental Health \& Psychiatry (CAAMP) Program in Calgary.
Child and Adolescent Addiction, Mental Health & Psychiatry
Calgary, Alberta, Canada
We will be collecting a 4mL saliva sample
Chad Bousman, PhD
University of Calgary
Paul Arnold, MD
University of Calgary
First Submitted
May 14, 2019
First Posted
May 16, 2019
Study Start
January 2, 2019
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
4 years
Contact the study team to confirm eligibility.
Study Completion
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 14, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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