About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 6 - 24 years
Medical records available
Diagnosis of MDD, anxiety disorder, or OCD
Current or past history of SSRI therapy
Disqualifiers
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.
Trial population
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.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Adverse Drug Reactions other than SIBD
A self-report instrument, The Antidepressant Side-Effect Checklist (ASEC) will be used to assess the presence of common adverse reactions to antidepressants.
Sponsors and contacts
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University of Calgary
Lead sponsor
Hotchkiss Brain Institute, University of Calgary
Collaborator
Alberta Health services
Collaborator