A Phase 1 interventional study of Trazodone and Placebo in Postpartum Depression, sponsored by Verinder Sharma. Withdrawn at 1 site in Canada. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Verinder Sharma · Phase 1, Interventional, and Prevention
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.
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
Browse Depression, Postpartum studies →Verinder Sharma is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy outpatients with a history of Major depressive disorder who are currently not on any psychotropic medications and who:
Exclusion Criteria:
Trazodone once daily for 24 weeks.
Drug: Trazodone
Placebo once daily for 24 weeks
Drug: Placebo
Trazodone capsule once daily
Placebo capsule once daily
Occurrence of Major depressive episode
Participants having a score of \>7 on the Hamilton Depression Rating Scale (Max 52) will be assessed using the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders- 5 (SCID-5) to establish recurrence of an major depressive episode. A higher score indicates recurrence of an MDE
Time frame: 27 weeks
Time to occurrence of Major Depressive Episode (MDE)
The time from childbirth until they develop MDE
Time frame: 27 weeks
Hamilton Depression Rating Scale
The change in Hamilton Depression Rating Scale and Scale from baseline to 24 weeks to measure change in depressive symptoms. The score ranges from 0-53 where a higher score is a worse outcome.
Time frame: 24 weeks
Edinburgh Postnatal Depression
The change in Edinburgh Postnatal Depression Scale from baseline to 24 weeks to measure the change in depressive symptoms. The scores range from 0 to 30 with 30 indicating more depression symptoms.
Time frame: 24 weeks
Blood pressure
The systolic and diastolic blood pressure will be measured in mmHG.
Time frame: 27 weeks
Pulse
Pulse will be measured in Beats per minute
Time frame: 27 weeks
Body weight
Body weight will be measured in kilograms
Time frame: 27 weeks
Side effects
Side effects of Trazodone will be measured by the Frequency, Intensity, Burden of Side Effects Rating (FIBSER) scale
Time frame: 27 weeks
Maternal Functioning
Maternal Functioning will be measured by Barkin Index of Maternal Functioning. The sum of the scores is calculated, ranging from 0 to 120. Where a score of 120 means perfect functioning. The different between the scores scores will be looked at and a more positive score (8 week score is greater than baseline score) is a better outcome.
Time frame: 27 weeks
Development of mania symptoms
Mania symptoms will be measured by the Young Mania Rating Scale. here are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others. The score ranges from 0 to 60 where 60 indicates a worse outcome.
Time frame: 27 weeks
Pill count
Adherence to intervention
Time frame: 27 weeks
Retention rate
The following criteria will be used to determine the success of the study: enrollment of 1 participant every 2 weeks, and recruitment of at least 60% of all patients considered eligible to participate in the study
Time frame: 27 weeks
Complete blood count (CBC)
The CBC is a blood test to check the overall health of the participant
Time frame: 27 weeks
Thyroid Stimulating Hormone test
a blood test that measures Thyroid Stimulating Hormone measured in the units mIU/L
Time frame: 27 weeks
Electrocardiogram QT Interval
test that checks the QT interval of the heart. This will let us know if the participants have heart abnormalities or if the medication has made changes to the heart of the participant.
Time frame: 27 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Verinder Sharma