Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone
Key facts
- Who runs it
- Verinder Sharma
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Phase
- Phase 1
- Started
- 17 Apr 2025
- Ended
- 31 Aug 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Trazodone
- Placebo
- Record updated
- 4 April 2025
- Why it stopped
- This study was pivoted to be a randomized control trial of trazodone versus quetiapine, under a new NTC identification number (study protocol number 125638).
Who can take part
- Age
- 18 years to 45 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Healthy outpatients with a history of Major depressive disorder who are currently not on any psychotropic medications and who:
- are 18- 45 years old,
- are pregnant with gestation of 28-34 weeks,
- have been in full remission of depression for > 2 months (as per Diagnostic and Statistical Manual-5),
- are able to communicate in English,
- are capable of providing informed consent,
- are planning to deliver at Victoria Hospital in London Ontario, and
- live in London and the surrounding area, will be enrolled
Who cannot take part
- use of psychotropic medication over the previous 2 months,
- currently receiving psychotherapy
- current psychiatric disorder other than generalized anxiety,
- history of bipolar disorder or psychosis,
- high risk for suicide (actively suicidal or a score of ≥ 3 on item #3 on the Hamilton Depression Rating Scale-17 item [HDRS]),
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Postpartum depression is a serious illness that affects approximately 17% of women who have recently given birth. Untreated depression appears to have negative effects for both the mother and her baby. Postpartum depression is quite common among women with a history of depression. Sleeplessness is a common concern during pregnancy and after delivery, and it can also trigger depression in women with a history of depression. Antidepressants are the most commonly recommended drugs for prevention of postpartum depression; however, there is limited research to understand the effectiveness of the medications in preventing postpartum depression. Trazodone is a weak antidepressant, but it is commonly prescribed for sleeplessness due to physical or psychiatric disorders. We are planning a study to find out whether trazodone in a low dose is more effective than a sugar pill in preventing postpartum depression among women with histories of depression. We expect the results of our study will make it easier for healthcare providers to select the right medication for women who are at risk of developing depression after delivery and thus improve the mental health of mothers and well-being of their babies.
The 2 groups in the trial
- TrazodoneTreatment being tested
Trazodone once daily for 24 weeks.
- PlaceboPlacebo, for comparison
Placebo once daily for 24 weeks
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 4 April 2025