← Back to Search

Antidepressant

Trazodone for Postpartum Depression

Phase 1

Waitlist Available

Led By Verinder Sharma, MB

Research Sponsored by Verinder Sharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

In full remission of depression for > 2 months (as per Diagnostic and Statistical Manual-5)

Healthy outpatients with a history of Major depressive disorder who are currently not on any psychotropic medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 27 weeks

Awards & highlights

Study Summary

This trial will test whether trazodone, a weak antidepressant, is more effective than a placebo in preventing postpartum depression among women with a history of depression.

Who is the study for?

This trial is for pregnant women aged 18-45 in London, Ontario, who have a history of depression but are currently not on any psychotropic medications. They must be between 28-34 weeks pregnant, able to communicate in English, and planning to deliver at Victoria Hospital. Women with bipolar disorder or psychosis, current psychotherapy patients, those with other psychiatric disorders or recent psychotropic medication use are excluded.Check my eligibility

What is being tested?

The study tests if low-dose Trazodone prevents postpartum depression better than a placebo (sugar pill) among women with histories of depression. It aims to help healthcare providers choose the right medication for preventing depression after childbirth.See study design

What are the potential side effects?

Trazodone can cause drowsiness, dizziness, constipation, blurred vision and fatigue. As it's used here in a low dose for sleep issues related to preventing postpartum depression rather than as an antidepressant per se; side effects might differ.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been depression-free for over 2 months.

Select...

I have depression but am not currently taking any mental health medications.

Select...

I am between 18 and 45 years old.

Select...

I am pregnant and between 28 to 34 weeks along.

Select...

I have major depressive disorder but am not currently taking any mental health medications.

Select...

I am between 18 and 45 years old.

Select...

I am pregnant and between 28 to 34 weeks along.

Select...

I have been depression-free for over 2 months.

Select...

I am able to understand and agree to the study's procedures and risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 27 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~27 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Occurrence of Major depressive episode

Secondary outcome measures

Blood pressure

Body weight

Complete blood count (CBC)

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TrazodoneExperimental Treatment1 Intervention

Trazodone once daily for 24 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Placebo once daily for 24 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trazodone

2011

Completed Phase 4

~2380

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Verinder SharmaLead Sponsor

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Postpartum Depression

30 Patients Enrolled for Postpartum Depression

Verinder Sharma, MBPrincipal InvestigatorLawson Health Research Institute

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Postpartum Depression

30 Patients Enrolled for Postpartum Depression

Media Library

Trazodone (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT05299398 — Phase 1

Postpartum Depression Research Study Groups: Trazodone, Placebo

Postpartum Depression Clinical Trial 2023: Trazodone Highlights & Side Effects. Trial Name: NCT05299398 — Phase 1

Trazodone (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05299398 — Phase 1

Frequently Asked Questions

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

Is there an ongoing call for volunteers to join this trial?

"The details published on clinicaltrials.gov indicate that the trial, which was made available to view on September 1st 2022 and most recently amended August 10th 2022, is not actively recruiting patients at this time. Nevertheless, there are a variety of other trials with open enrolment currently seeking participants."

Answered by AI

Does the current research include individuals who are geriatric?

"According to the trial's admission criteria, only individuals between 18 and 45 years of age qualify for enrollment."

Answered by AI

Is it possible to participate in this clinical exploration?

"Qualifying participants must be between 18 and 45 years old, suffering from depression or postpartum. Currently, 28 volunteers are sought to join this medical trial."

Answered by AI

Has Trazodone been given the green light from the U.S. Food and Drug Administration?

"Due to the preliminary nature of this clinical trial, our team at Power has assigned Trazodone a safety rating of 1. This is because Phase 1 trials have only limited data indicating efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone

Verinder Sharma 2022. "Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05299398.