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Postpartum DepressionPhase 1NCT04950868

The Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression

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

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Postpartum depression is a serious disorder that affects approximately 14% of women who have recently given birth. Postpartum depression is either an episode of major depressive disorder (only low periods) or bipolar disorder (periods of lows and highs). 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?
Quetiapine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteCanada
Study dates
18 Mar 2022to 1 Jun 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Outpatient woman between ages 18 - 45
  • Within 6 months of delivery
  • Have a DSM-5 diagnosis of MDD or BD I, BD II or other specified bipolar or related disorder with peripartum onset
  • Have a score of >18 on the 17-item Hamilton Depression Rating Scale (HDRS)
  • Have a score of ≤12 Young Mania Rating Scale (YMRS) at both the screening and baseline visits
  • Able to communicate in English
  • Capable of providing informed consent

Who cannot join

  • A diagnosis of schizophrenia spectrum or other psychotic disorders, obsessive-compulsive disorder, eating disorders, substance-related and addictive disorders
  • At high risk for suicide (actively suicidal or a score of ≥ 3 on item #3 on the HDRS)
  • Receiving a psychotropic drug such a mood stabilizer, an antidepressant or a sedative/hypnotic.
  • Receiving psychotherapy
  • Have a physical illness that is a contraindication to the use of quetiapine, or who have a history of intolerance or nonresponse to quetiapine
  • Pregnant or planning on becoming pregnant during the study

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Parkwood Institute

    London, Ontario, N6C 5J1

Other trials in Canada

About this study

Official title: A Pilot Study on the Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression

Postpartum depression is a serious disorder that affects approximately 14% of women who have recently given birth. Postpartum depression is either an episode of major depressive disorder (only low periods) or bipolar disorder (periods of lows and highs).

Untreated postpartum depression can negatively affect the mother, the infant and the family. Antidepressants are the most used treatments; however, for many women these drugs are not useful, resulting in a pressing need for effective treatments for postpartum depression. Lack of sleep is common after delivery and can trigger depression in some women. Quetiapine, a drug used for bipolar disorder, major depressive disorder and occasionally sleeplessness has not been well studied in postpartum depression. This study aims to find out how mothers tolerate the drug and whether it is effective for postpartum depression. Results of this study may help investigators carry out a larger study comparing quetiapine and placebo (a sugar pill) in postpartum depression.

Being tested
Quetiapine
Keywords
Quetiapine, postpartum, Drug therapy, Major depressive disorder
Medical subject headings
Depression, Postpartum, Depressive Disorder, Major

What participants receive

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

  • QuetiapineDrug

    They will initially be given 25 mg of quetiapine per day. The dose may be increased by 25-50 mg per week, to a maximum dose of 150 mg per day by week 6 of the study.

Study groups in NCT04950868
Study groupRoleWhat they receive
QuetiapineExperimentalThey will initially be given 25 mg of quetiapine per day. The dose may be increased by 25-50 mg per week, to a maximum dose of 150 mg per day by week 6 of the study.
Receives: Drug: Quetiapine

What is being measured

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

  1. Recruitment and retention rate

    Data on the recruitment rate, refusal rate, retention rate will be used to assess feasibility

    Measured: 10 weeks

  2. Blood pressure

    The measurement of blood pressure (both systolic and diastolic blood pressure) will be measured in mm HG

    Measured: 8 weeks

  3. Incidence of Treatment-Emergent Adverse Events as assessed by the Systematic Monitoring of Adverse events Related to TreatmentS (SMARTS) score

    The Systematic Monitoring of Adverse events Related to TreatmentS (SMARTS), will be used to gather information about side effects of quetiapine. It is a check list to identify potential side effects.

    Measured: 8 weeks

  4. Maternal functioning will be measured by the Barkin Index of Maternal Functioning (BIMF)

    Tolerability described as the degree to which overt adverse effects are tolerated, will be measured using the Barkin Index of Maternal Functioning (BIMF). The Barkin Index of Maternal Functioning score from baseline to week 8 will also be assessed. 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: 8 weeks

  5. Pulse

    Pulse will be measured in beats per minute

    Measured: 8 weeks

  6. Body mass index

    Weight (km) and height (m) will be used to calculate BMI (kg/m^2)

    Measured: 8 weeks

  7. Fasting lipid panel test

    The fasting lipid panel will be completed to measure safety of the intervention. This measures lipid levels (Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides). All measured in mg/dL

    Measured: 8 weeks

  8. glycated haemoglobin (HbA1c) tests

    Glycated haemoglobin (HbA1C) test will be done to measure glycated haemoglobin which will measure the safety of the intervention. It will be measured in mmol/mol and as a percentage.

    Measured: 8 weeks

  9. Waist circumference

    Waist circumference (cm) will help measure the safety of the intervention

    Measured: 8 weeks

  10. Returned tablet count

    Adherence will be determined by returned tablet count.

    Measured: 8 weeks

Secondary outcomes (4)

  1. Hamilton Depression Rating (HDRS) total score

    Secondary outcome will be the mean change from baseline to week 8 in the Hamilton Depression Rating (HDRS) total score, the proportion of participants achieving response (≥50% reduction in HDRS score at baseline) and the proportion of participants achieving remission (HDRS ≤12). The score ranges from 0-53 where a higher score is a worse outcome.

    Measured: 8 weeks

  2. Edinburgh Postnatal Depression Scale

    The mean change in scores of Edinburgh Postnatal Depression Scale. The scores range from 0 to 30 with 30 indicating more depression symptoms.

    Measured: 8 weeks

  3. Generalized Anxiety Disorder 7-item scale

    The mean change in scores of Generalized Anxiety Disorder 7-item scale. The scores range from 0 to 21. A higher generalized anxiety score indicates higher anxiety and indicating a worse outcome.

    Measured: 8 weeks

  4. Young Mania Rating Scale

    The mean change in scores of Young Mania Rating Scale. The YMRS is a rating scale used to evaluate manic symptoms at baseline and over time in individuals with mania. There 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: 8 weeks

Timeline

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

  1. First posted6 Jul 2021
  2. Study start18 Mar 2022
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04950868
Sponsor's protocol ID
118885
Status last verified
Mar 2025
First submitted
11 Jun 2021
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There will be no sharing plan needed because no individual participant data (IPD) will be available to other researchers.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Quetiapine 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Recruitment and retention rate (time frame: 10 weeks). The study lists 10 primary outcomes in all. 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 NCT04950868.

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 5 Mar 2025.

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