A Phase 1 interventional study of Quetiapine in Postpartum Depression, sponsored by Verinder Sharma. Active, not recruiting at 1 site in Canada. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by Verinder Sharma · Phase 1, Interventional, and Treatment
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.
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
This study's enrollment of 22 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Verinder Sharma is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Quetiapine
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.
Recruitment and retention rate
Data on the recruitment rate, refusal rate, retention rate will be used to assess feasibility
Time frame: 10 weeks
Blood pressure
The measurement of blood pressure (both systolic and diastolic blood pressure) will be measured in mm HG
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
Pulse
Pulse will be measured in beats per minute
Time frame: 8 weeks
Body mass index
Weight (km) and height (m) will be used to calculate BMI (kg/m\^2)
Time frame: 8 weeks
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
Time frame: 8 weeks
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.
Time frame: 8 weeks
Waist circumference
Waist circumference (cm) will help measure the safety of the intervention
Time frame: 8 weeks
Returned tablet count
Adherence will be determined by returned tablet count.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
Plan to share: No — There will be no sharing plan needed because no individual participant data (IPD) will be available to other researchers.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Verinder Sharma