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

Postpartum Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05299398
• Other study ID #: 120394
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: August 2022
• Source: Lawson Health Research Institute
• Contact: Verinder Sharma, MB
• Phone: 519-455-5110
• Email: vsharma[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: March 31, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Drug:
• Trazodone
Trazodone capsule once daily
• Placebo
Placebo capsule once daily

Locations

Country	Name	City	State
Canada	Parkwood Institute Mental Health Care Building	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Verinder Sharma

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	27 weeks
Secondary	Time to occurrence of Major Depressive Episode (MDE)	The time from childbirth until they develop MDE	27 weeks
Secondary	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.	24 weeks
Secondary	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.	24 weeks
Secondary	Blood pressure	The systolic and diastolic blood pressure will be measured in mmHG.	27 weeks
Secondary	Pulse	Pulse will be measured in Beats per minute	27 weeks
Secondary	Body weight	Body weight will be measured in kilograms	27 weeks
Secondary	Side effects	Side effects of Trazodone will be measured by the Frequency, Intensity, Burden of Side Effects Rating (FIBSER) scale	27 weeks
Secondary	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.	27 weeks
Secondary	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.	27 weeks
Secondary	Pill count	Adherence to intervention	27 weeks
Secondary	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	27 weeks
Secondary	Complete blood count (CBC)	The CBC is a blood test to check the overall health of the participant	27 weeks
Secondary	Thyroid Stimulating Hormone test	a blood test that measures Thyroid Stimulating Hormone measured in the units mIU/L	27 weeks
Secondary	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.	27 weeks