Pharmacogenetics of Antidepressant-Induced Disinhibition
PGx-AID
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2019
CompletedFirst Submitted
Initial submission to the registry
May 14, 2019
CompletedFirst Posted
Study publicly available on registry
May 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedMay 9, 2024
May 1, 2024
6.5 years
May 14, 2019
May 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
Adverse Drug Reactions other than SIBD
4 years
Eligibility Criteria
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.
You may qualify if:
- Aged 6 - 24 years
- Medical records available
- Diagnosis of MDD, anxiety disorder, or OCD
- Current or past history of SSRI therapy
You may not qualify if:
- Inability of parent/legal guardian to give informed consent
- Inability of the child to give informed assent
- Unwillingness of child to provide saliva sample for genetic analysis
- Current, past or suspected diagnosis of attention deficit hyperactivity disorder, oppositional defiant disorder, conduct disorder, bipolar disorder, psychotic disorder, or pervasive developmental disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Hotchkiss Brain Institute, University of Calgarycollaborator
- Alberta Health servicescollaborator
Study Sites (1)
Child and Adolescent Addiction, Mental Health & Psychiatry
Calgary, Alberta, Canada
Biospecimen
We will be collecting a 4mL saliva sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chad Bousman, PhD
University of Calgary
- PRINCIPAL INVESTIGATOR
Paul Arnold, MD
University of Calgary
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2019
First Posted
May 16, 2019
Study Start
January 2, 2019
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
May 9, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share