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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
Sponsor:
Collaborators:
Mathison Centre for Mental Health Education and Research
Alberta Health Services
Information provided by (Responsible Party):
University of Calgary

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.

Condition or disease
Obsessive-Compulsive Disorder Anxiety Disorders Major Depressive Disorder Antidepressant Drug Adverse Reaction

Detailed Description:

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.

Research Question:

Do children who experience SSRI-induced behavioral disinhibition (SIBD) have a distinct pharmacogenetic profile relative to children who do not have these adverse experiences?

Methodology:

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.


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.



Secondary Outcome Measures :
  1. 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
We will be collecting a 4mL saliva sample


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
SSRI-treated children diagnosed with major depression, anxiety and OCD, aged 6 to 17 years recruited from the Child and Adolescent Addiction, Mental Health & Psychiatry (CAAMP) Program in Calgary.
Criteria

Inclusion Criteria:

  1. Aged 6 - 17 years
  2. Medical records available
  3. Diagnosis of MDD, anxiety disorder, or OCD
  4. Current or past history of SSRI therapy

Exclusion Criteria:

  1. Inability of parent/legal guardian to give informed consent
  2. Inability of the child to give informed assent
  3. Unwillingness of child to provide saliva sample for genetic analysis
  4. Current, past or suspected diagnosis of attention deficit hyperactivity disorder, oppositional defiant disorder, conduct disorder, bipolar disorder, psychotic disorder, or pervasive developmental disorder.

Information from the National Library of Medicine

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


Contacts
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Contact: Camilia Thieba, MSc 403-210-6353 camilia.thieba@ucalgary.ca
Contact: Abdullah Al Maruf, PhD abdullahal.maruf@ucalgary.ca

Locations
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Canada, Alberta
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         
Sponsors and Collaborators
University of Calgary
Mathison Centre for Mental Health Education and Research
Alberta Health Services
Investigators
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Principal Investigator: Chad Bousman, PhD University of Calgary
Principal Investigator: Paul Arnold, MD University of Calgary

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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03953014     History of Changes
Other Study ID Numbers: REB18-0519
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
SSRI
Depression
Children
OCD
Anxiety
Antidepressants
Additional relevant MeSH terms:
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Disease
Drug-Related Side Effects and Adverse Reactions
Depressive Disorder
Depressive Disorder, Major
Anxiety Disorders
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Mood Disorders
Mental Disorders
Personality Disorders
Chemically-Induced Disorders
Antidepressive Agents
Psychotropic Drugs