Quetiapine for Postpartum Depression

Overseen By Verinder Sharma, MB

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Verinder Sharma

Must not be taking: Mood stabilizers, Antidepressants, Sedatives

Disqualifiers: Schizophrenia, OCD, Eating disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

22 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 3 4 6 7}

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

Within 6 months of delivery

I am able to understand and agree to the study's procedures.

I have been diagnosed with major depression or bipolar disorder related to childbirth.

Exclusion Criteria

I am currently taking medication for my mood, depression, or sleep.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

8 weeks

Weekly visits for dose adjustment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Quetiapine Experimental Treatment 1 Intervention

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:

Approved in United States as Seroquel for:

• Bipolar disorder (depressive and manic episodes)
• Schizophrenia
• Major depressive disorder

Approved in European Union as Seroquel for:

• Schizophrenia
• Bipolar disorder (manic episodes)
• Major depressive episodes in bipolar disorder

Who Is Running the Clinical Trial?

Verinder Sharma

Lead Sponsor

Trials

2

Recruited

50+

Published Research Related to This Trial

In a study involving 286 patients with schizophrenia, high-dose quetiapine (up to 750 mg/d) significantly reduced positive symptoms compared to placebo, demonstrating its efficacy as an antipsychotic.

Quetiapine was well tolerated, showing a favorable safety profile without causing extrapyramidal symptoms or significant changes in blood parameters, suggesting it is a safe treatment option for schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quetiapine in patients with schizophrenia. A high- and low-dose double-blind comparison with placebo. Seroquel Study Group. Small, JG., Hirsch, SR., Arvanitis, LA., et al.[2022]

Citations

1. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D1449L00023

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

2. withpower.com withpower.com/trial/phase-1-depressive-disorder-8-2021-80c1d

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=results

Study 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, ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK501087/

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5734989/

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.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/022047Orig1s042lbl.pdf

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).