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

NCT05299398 | Withdrawn Phase 1

• 1 other identifier: 120394
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Postpartum depression; Trazodone; Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Time to occurrence of Major Depressive Episode (MDE)

  27 weeks

• Hamilton Depression Rating Scale

  24 weeks

• Edinburgh Postnatal Depression

  24 weeks

• Blood pressure

  27 weeks

• Pulse

  27 weeks

Study Arms (2)

Trazodone

EXPERIMENTAL

Trazodone once daily for 24 weeks.

Drug: Trazodone

Placebo

PLACEBO COMPARATOR

Placebo once daily for 24 weeks

Drug: Placebo

Interventions

Trazodone DRUG

Trazodone capsule once daily

Trazodone

Placebo DRUG

Placebo capsule once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Verinder Sharma: lead

Study Sites (1)

Parkwood Institute Mental Health Care Building

London, Ontario, N6C 0A7, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Study Officials

• Verinder Sharma, MB

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: March 29, 2022
• Study Start: April 17, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)