Prevention of Postpartum Depression: A Pilot Placebo-cont... | NCT05299398

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

NCT05299398

Sponsor

Verinder Sharma

Status

Withdrawn

Last Update Posted

Apr 4, 2025Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Postpartum Depression

Interventions

Trazodone
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was pivoted to be a randomized control trial of trazodone versus quetiapine, under a new NTC identification number (study protocol number 125638).

Expanded Access Info

Start Date

Apr 17, 2025Estimated

Primary Completion Date

Aug 31, 2025Estimated

Completion Date

Aug 31, 2025Estimated

First Submitted Date

Dec 30, 2021

First Submission Date that Met QC Criteria

Mar 18, 2022

First Posted Date

Mar 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2025

Last Update Posted Date

Apr 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Verinder Sharma, Principal Investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sSponsor-Investigator

Lead Sponsor

Verinder SharmaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trazodone	Experimental	Trazodone once daily for 24 weeks.	Drug: Trazodone
Placebo	Placebo Comparator	Placebo once daily for 24 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trazodone	Drug	Trazodone capsule once daily	Trazodone
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Time to occurrence of Major Depressive Episode (MDE)	The time from childbirth until they develop MDE	27 weeks
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Verinder Sharma, MB	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Parkwood Institute Mental Health Care Building		London	Ontario	N6C 0A7	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019052	Depression, Postpartum

Ancestor Terms

ID	Term
D011644	Puerperal Disorders
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014196	Trazodone

Ancestor Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011728	Pyridones

Browse Leaves

Not provided

Browse Branches

Not provided