Clinical trial NCT05299398: Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone
Official title: Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Postpartum Depression
Keywords: Postpartum depression
Trazodone
Prevention
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

1. are 18- 45 years old,
2. are pregnant with gestation of 28-34 weeks,
3. have been in full remission of depression for \> 2 months (as per Diagnostic and Statistical Manual-5),
4. are able to communicate in English,
5. are capable of providing informed consent,
6. are planning to deliver at Victoria Hospital in London Ontario, and
7. live in London and the surrounding area, will be enrolled.

Exclusion Criteria:

1. current psychiatric disorder other than generalized anxiety,
2. use of psychotropic medication over the previous 2 months,
3. history of bipolar disorder or psychosis,
4. high risk for suicide (actively suicidal or a score of ≥ 3 on item #3 on the Hamilton Depression Rating Scale-17 item \[HDRS\]),
5. currently receiving psychotherapy

Primary outcomes:
measure: Occurrence of Major depressive episode
timeFrame: 27 weeks
Secondary outcomes:
measure: Time to occurrence of Major Depressive Episode (MDE)
timeFrame: 27 weeks
measure: Hamilton Depression Rating Scale
timeFrame: 24 weeks
measure: Edinburgh Postnatal Depression
timeFrame: 24 weeks
measure: Blood pressure
timeFrame: 27 weeks
measure: Pulse
timeFrame: 27 weeks
measure: Body weight
timeFrame: 27 weeks
measure: Side effects
timeFrame: 27 weeks
measure: Maternal Functioning
timeFrame: 27 weeks
measure: Development of mania symptoms
timeFrame: 27 weeks
measure: Pill count
timeFrame: 27 weeks
measure: Retention rate
timeFrame: 27 weeks
measure: Complete blood count (CBC)
timeFrame: 27 weeks
measure: Thyroid Stimulating Hormone test
timeFrame: 27 weeks
measure: Electrocardiogram QT Interval
timeFrame: 27 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: Parkwood Institute Mental Health Care Building
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Verinder Sharma, MB
role: PRINCIPAL_INVESTIGATOR
References: