Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03953014
Study type Observational
Source University of Calgary
Contact Madison Heintz, MSW
Phone 5875739747
Email psychpgxlab@ucalgary.ca
Status Recruiting
Phase
Start date January 2, 2019
Completion date June 30, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05537558 - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Completed NCT03142919 - Lipopolysaccharide (LPS) Challenge in Depression Phase 2
Recruiting NCT05547035 - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders N/A
Terminated NCT02940769 - Neurobiological Effects of Light on MDD N/A
Recruiting NCT05892744 - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression Phase 4
Recruiting NCT05537584 - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment Phase 4
Active, not recruiting NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Phase 3
Completed NCT04479852 - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder Phase 2
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Recruiting NCT05527951 - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study N/A
Completed NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT04392947 - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation N/A
Recruiting NCT05895747 - 5-HTP and Creatine for Depression R33 Phase Phase 2
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Recruiting NCT05813093 - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression N/A
Recruiting NCT05135897 - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation NCT04509102 - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder Early Phase 1
Recruiting NCT06026917 - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) Phase 4
Recruiting NCT06145594 - EMA-Guided Maintenance TMS for Depression N/A