Pharmacogenetics of Antidepressant-Induced Disinhibition

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorUniversity of Calgary

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
4 years
2

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.

Time frame
4 years

Secondary outcomes

1

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.

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Hotchkiss Brain Institute, University of Calgary

Collaborator

Alberta Health services

Collaborator