Quetiapine for Postpartum Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of quetiapine in treating postpartum depression, a common issue for new mothers. Quetiapine is already used for mood disorders and sometimes sleeplessness, but researchers aim to determine its benefits for mothers experiencing low moods after childbirth. Women who have given birth within the last six months and have been diagnosed with depression or bipolar disorder might be suitable candidates. The study will assess how mothers respond to the medication and its potential benefits, with the goal of paving the way for larger studies in the future. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any psychotropic drugs (medications that affect your mood, thoughts, or behavior) such as mood stabilizers, antidepressants, or sedatives/hypnotics to participate in this trial.
Is there any evidence suggesting that quetiapine is likely to be safe for humans?
Research shows that quetiapine is generally well-tolerated by patients. In studies involving individuals with depression and anxiety, quetiapine improved symptoms and mostly caused only minor side effects. Common issues included mild drowsiness or dry mouth. Notably, it rarely causes movement-related side effects, which is a positive aspect.
For postpartum depression, detailed safety information remains limited. However, the FDA has approved quetiapine for conditions like bipolar disorder and major depressive disorder, indicating it has passed safety tests for those uses. This might suggest some level of safety for postpartum depression as well. As this is an early-phase trial, the researchers are currently focusing on how well mothers tolerate the drug.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for postpartum depression, such as SSRIs or SNRIs, quetiapine offers a different approach by acting on multiple neurotransmitter systems. Quetiapine primarily affects serotonin and dopamine receptors, which may help address a wider range of mood symptoms and provide a quicker onset of relief. Researchers are excited about quetiapine because it has the potential to improve mood stabilization and reduce anxiety, offering a new avenue for those who might not respond well to existing antidepressants.
What evidence suggests that quetiapine might be an effective treatment for postpartum depression?
Research shows that quetiapine, which participants in this trial will receive, can help treat depression. In past studies, quetiapine effectively reduced depression symptoms in people with major depressive disorder. Although primarily used for bipolar disorder and depression, it has also helped with sleep problems, which can lead to postpartum depression. Early results suggest that quetiapine might improve mood and sleep in those with postpartum depression. More research is needed to confirm these effects specifically for postpartum depression, but the drug has shown promise in treating other mood disorders.13467
Who Is on the Research Team?
Verinder Sharma, MB
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Are You a Good Fit for This Trial?
This trial is for outpatient women aged 18-45 who have given birth within the last 6 months and are experiencing postpartum depression, as indicated by specific scores on depression rating scales. They must be able to consent, communicate in English, and not be at high risk for suicide or currently receiving certain psychiatric treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive quetiapine starting at 25 mg per day, with potential increases of 25-50 mg per week, up to a maximum of 150 mg per day by week 6
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Quetiapine
Trial Overview
The study is testing Quetiapine's safety and effectiveness in treating postpartum depression. It aims to determine how well mothers tolerate this medication, which is typically used for bipolar disorder and major depressive disorder.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Quetiapine is already approved in United States, European Union for the following indications:
- Bipolar disorder (depressive and manic episodes)
- Schizophrenia
- Major depressive disorder
- Schizophrenia
- Bipolar disorder (manic episodes)
- Major depressive episodes in bipolar disorder
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Who Is Running the Clinical Trial?
Verinder Sharma
Lead Sponsor
Published Research Related to This Trial
Citations
Quetiapine in Postpartum Depression
The purpose of the study is to evaluate the efficacy and tolerability of quetiapine in female patients with postpartum depressive disorder with psychotic
Quetiapine for Postpartum Depression · Info for Participants
In a study involving 286 patients with schizophrenia, high-dose quetiapine (up to 750 mg/d) significantly reduced positive symptoms compared to placebo, ...
3.
psychiatrist.com
psychiatrist.com/jcp/randomized-placebo-controlled-effectiveness-study-quetiapine-xr-comorbid-depressive-anxiety-disorders/Randomized, Placebo-Controlled Effectiveness Study of ...
On primary outcome measures, quetiapine was superior to placebo in improving depression (17-item Hamilton Depression Rating Scale score: mean ...
4.
clinicaltrials.gov
clinicaltrials.gov/study/NCT00681668?cond=Postpartum%20psychosis&viewType=Table&rank=5&tab=resultsStudy Results | Quetiapine in Postpartum Depression
It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...
Quetiapine - Drugs and Lactation Database (LactMed®) - NCBI
A woman began using quetiapine 4 weeks postpartum for intrusive thoughts. She took her daily dose of 50 mg at 11 pm after the last nursing of ...
Quetiapine Dose Adjustments in Pregnant and Postpartum ...
These data indicate that plasma concentrations of quetiapine are lower in pregnancy compared to postpartum and that doses may need to be increased in pregnancy.
Seroquel XR - accessdata.fda.gov
... quetiapine have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data).
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