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Pharmacogenetic-Guided Dosing for Depression (PGx-GAP Trial)
N/A
Recruiting
Led By Chad Bousman, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 to 12 weeks
Awards & highlights
PGx-GAP Trial Summary
This trial tests if personalized medicine can help teens with depression who don't respond to first-line treatments. 456 will be randomly assigned to get personalized or standard care.
Who is the study for?
This trial is for adolescents aged 12-17 who didn't get better or couldn't tolerate the antidepressant fluoxetine. They must be fluent in English, planning to start a new SSRI medication, and have moderate-to-severe depression symptoms without certain genetic tests done before.Check my eligibility
What is being tested?
The study compares two ways of choosing antidepressants: one based on the teen's genetics (experimental) and the other following standard guidelines (control). Each participant will receive their assigned treatment for 12 weeks after being randomly chosen to either group.See study design
What are the potential side effects?
Possible side effects from SSRIs can include nausea, sleepiness or insomnia, dry mouth, dizziness, nervousness or restlessness. The specific side effects may vary depending on which SSRI is prescribed.
PGx-GAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with depression remission
Secondary outcome measures
Change in behavioral activation
Change in health care utilization
Change in health-related quality of life
+6 moreOther outcome measures
Blinding fidelity
Intervention fidelity
Minimally clinically important differences
PGx-GAP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pharmacogenetic (PGx)-GuidedExperimental Treatment1 Intervention
Participants and their physician will receive a one-time prescribing report after completing baseline for second-line selective serotonin reuptake inhibitors with dosing information based on CYP2B6, CYP2C19, and CYP2D6 genotype data.
Group II: Guidelines for Adolescent Depression in Primary Care (GLAD-PC)-GuidedActive Control1 Intervention
Participants and their physician will receive a one-time prescribing report after completing baseline for second-line selective serotonin reuptake inhibitors based on GLAD-PC dosing guidelines.
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Who is running the clinical trial?
University of CalgaryLead Sponsor
792 Previous Clinical Trials
868,702 Total Patients Enrolled
31 Trials studying Depression
10,188 Patients Enrolled for Depression
University of AlbertaOTHER
889 Previous Clinical Trials
384,725 Total Patients Enrolled
18 Trials studying Depression
8,426 Patients Enrolled for Depression
Chad Bousman, PhDPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
6,120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I started or plan to start/change psychotherapy or brain stimulation therapy soon.I have tried 3 or more antidepressants, including fluoxetine, without success.I have been tested for CYP2B6, CYP2C19, or CYP2D6.Fluoxetine did not work for me or caused side effects I couldn't tolerate.I plan to begin taking a new SSRI medication.My main health issue is depression, as confirmed by my doctor.I am between 12 and 17 years old.I have had a liver or bone marrow transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Pharmacogenetic (PGx)-Guided
- Group 2: Guidelines for Adolescent Depression in Primary Care (GLAD-PC)-Guided
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom is this medical trial open for participation?
"To participate in this research, adolescents between the ages of 12 and 17 with a diagnosis of depression are needed. The desired sample size for this project is 452 participants."
Answered by AI
Is the age cutoff for this medical experiment set at sixty years or below?
"This clinical trial is for pediatric patients, and requires participants to be aged from 12-17. 193 studies are currently available on the subject of minors while 859 focus on senior citizens over 65 years old."
Answered by AI
Are fresh participants able to join this study?
"According to the details posted on clinicaltrials.gov, this medical study has ceased patient recruitment for now. The trial was initially made available on September 1st 2023 and its latest update occurred on July 25th 2023. However, 1175 other studies are still recruiting patients at present."
Answered by AI
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