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

NCT ID: NCT05299398

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-17
• Study Completion Date: 2025-08-31

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.

Conditions

Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Trazodone

Trazodone once daily for 24 weeks.

Group Type: EXPERIMENTAL

Trazodone

Intervention Type: DRUG

Trazodone capsule once daily

Placebo

Placebo once daily for 24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsule once daily

Interventions

Trazodone

Trazodone capsule once daily

Intervention Type: DRUG

Placebo

Placebo capsule once daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Verinder Sharma

OTHER

Sponsor Role: lead

Responsible Party

Verinder Sharma

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Verinder Sharma, MB

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

Parkwood Institute Mental Health Care Building

London, Ontario, Canada

Countries

Canada

Other Identifiers

120394

Identifier Type: -

Identifier Source: org_study_id