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Postpartum DepressionPhase 1NCT05299398

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

A Phase 1 study testing Trazodone in people with Postpartum Depression, run by Verinder Sharma at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Postpartum Depression
What is being tested?
Trazodone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteCanada
Study dates
17 Apr 2025to 31 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Parkwood Institute Mental Health Care Building

    London, Ontario, N6C 0A7

Other trials in Canada

About this study

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.

Being tested
Trazodone, Placebo
Keywords
Postpartum depression, Trazodone, Prevention
Medical subject headings
Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrazodoneDrug

    Trazodone capsule once daily

  • PlaceboDrug

    Placebo capsule once daily

Study groups in NCT05299398
Study groupRoleWhat they receive
TrazodoneExperimentalTrazodone once daily for 24 weeks.
Receives: Drug: Trazodone
PlaceboPlacebo comparatorPlacebo once daily for 24 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 27 weeks

Secondary outcomes (14)

  1. Time to occurrence of Major Depressive Episode (MDE)

    The time from childbirth until they develop MDE

    Measured: 27 weeks

  2. 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.

    Measured: 24 weeks

  3. 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.

    Measured: 24 weeks

  4. Blood pressure

    The systolic and diastolic blood pressure will be measured in mmHG.

    Measured: 27 weeks

  5. Pulse

    Pulse will be measured in Beats per minute

    Measured: 27 weeks

  6. Body weight

    Body weight will be measured in kilograms

    Measured: 27 weeks

  7. Side effects

    Side effects of Trazodone will be measured by the Frequency, Intensity, Burden of Side Effects Rating (FIBSER) scale

    Measured: 27 weeks

  8. 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.

    Measured: 27 weeks

  9. 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.

    Measured: 27 weeks

  10. Pill count

    Adherence to intervention

    Measured: 27 weeks

  11. 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

    Measured: 27 weeks

  12. Complete blood count (CBC)

    The CBC is a blood test to check the overall health of the participant

    Measured: 27 weeks

  13. Thyroid Stimulating Hormone test

    a blood test that measures Thyroid Stimulating Hormone measured in the units mIU/L

    Measured: 27 weeks

  14. 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.

    Measured: 27 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2022
  2. Study start17 Apr 2025 (estimated)
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion31 Aug 2025 (estimated)

Why it 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).

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05299398
Sponsor's protocol ID
120394
Status last verified
Apr 2025
First submitted
30 Dec 2021
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Trazodone in people with Postpartum Depression, run by Verinder Sharma at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Major depressive episode (time frame: 27 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05299398.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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