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

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.

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

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.

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.

Side effects of Trazodone will be measured by the Frequency, Intensity, Burden of Side Effects Rating (FIBSER) scale

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.

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.

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

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.

Inclusion Criteria: 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. Exclusion Criteria: current psychiatric disorder other than generalized anxiety, use of psychotropic medication over the previous 2 months, 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]), currently receiving psychotherapy