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Patient Decision Aid for Antidepressant Use During Pregnancy

N/A
Waitlist Available
Led By Simone Vigod, MD, MSc
Research Sponsored by Women's College Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Are unable to complete relevant study procedures online
Have active suicide ideation or psychosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-12 months after birth
Awards & highlights

Summary

This trial will assess whether an online patient decision aid can help women with depression make decisions about antidepressant use during pregnancy.

Who is the study for?
This trial is for women over 18 in Canada who are pregnant or planning to conceive within a year, diagnosed with depression, and deciding whether to start or continue SSRI/SNRI antidepressants. It's not for those with active suicidal thoughts, psychosis, substance abuse issues in the last year, major obstetrical/fetal complications, or inability to complete procedures online/in English.
What is being tested?
The study tests an online patient decision aid (PDA) designed to help pregnant women make informed choices about using antidepressants during pregnancy. The PDA will be compared against standard resources through a randomized controlled trial to see if it improves decision-making satisfaction.
What are the potential side effects?
Since this trial involves the use of informational tools rather than medical treatments, there are no direct side effects from interventions being studied. However, decisions made post-consultation may have implications on mental health and pregnancy.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot complete study tasks online.
Select...
I am currently experiencing thoughts of harming myself or have psychosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-12 months after birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-12 months after birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Postpartum depression as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (SCID-I)
Secondary study objectives
Anxiety disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Bipolar disorder as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Child Development as measured by the Ages and Stages Questionnaire (ASQ-3)
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Electronic Patient Decision AidExperimental Treatment2 Interventions
Participants login to a website where they access the interactive PDA as well as access standard published information and resources.
Group II: Standard Resource SheetPlacebo Group1 Intervention
Participants login to a website where they access standard published information and resources.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard Resource Sheet
2015
N/A
~160
Electronic Patient Decision Aid
2015
N/A
~100

Find a Location

Who is running the clinical trial?

Women's College HospitalLead Sponsor
106 Previous Clinical Trials
43,014 Total Patients Enrolled
11 Trials studying Depression
2,035 Patients Enrolled for Depression
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,373 Previous Clinical Trials
26,518,668 Total Patients Enrolled
46 Trials studying Depression
3,273,199 Patients Enrolled for Depression
Simone Vigod, MD, MScPrincipal InvestigatorWomen's College Hospital
3 Previous Clinical Trials
337 Total Patients Enrolled
2 Trials studying Depression
256 Patients Enrolled for Depression

Media Library

Electronic Patient Decision Aid Clinical Trial Eligibility Overview. Trial Name: NCT03632863 — N/A
Depression Research Study Groups: Electronic Patient Decision Aid, Standard Resource Sheet
Depression Clinical Trial 2023: Electronic Patient Decision Aid Highlights & Side Effects. Trial Name: NCT03632863 — N/A
Electronic Patient Decision Aid 2023 Treatment Timeline for Medical Study. Trial Name: NCT03632863 — N/A
~0 spots leftby Oct 2024
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