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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-12 months after birth

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-12 months after birth

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Postpartum depression as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (SCID-I)

Secondary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Women's College HospitalLead Sponsor

100 Previous Clinical Trials

38,229 Total Patients Enrolled

11 Trials studying Depression

2,035 Patients Enrolled for Depression

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,341 Previous Clinical Trials

26,452,139 Total Patients Enrolled

44 Trials studying Depression

3,272,725 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have been accepted into the experiment?

"Affirmative. Clinicaltrials.gov records indicate that this trial, established on October 18th 2018, is actively looking for participants. The investigation requires 574 subjects from a single medical centre to take part in the research."

Answered by AI

Is enrollment currently open for this experiment?

"The information hosted on clinicaltrials.gov confirms that this medical research is actively recruiting patients; it was first posted in October 2018 and the latest update occurred on February 4th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PDA for Antidepressant Use in Pregnancy

Simone Vigod 2018. "PDA for Antidepressant Use in Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03632863.

All > Depression > Pregnancy