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

Trial Summary

What is the purpose of this trial?

This trial is testing quetiapine, a medication for mood disorders and sleep problems, on women with postpartum depression who don't respond well to typical antidepressants. The drug works by balancing brain chemicals to improve mood and sleep. Quetiapine has been used for treating schizophrenia, mood disorders, and sleep disturbances.

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.

What data supports the effectiveness of the drug quetiapine for postpartum depression?

Quetiapine is effective in treating depression in people with bipolar disorder, showing rapid and sustained improvements in depressive and anxiety symptoms. It is also used off-label for anxiety and insomnia, which are common in postpartum depression, suggesting it might help with similar symptoms in this condition. ^{1 2 3 4 5}

Is quetiapine generally safe for humans?

Quetiapine, also known as Seroquel, is generally well tolerated in adults and adolescents for conditions like bipolar disorder and schizophrenia. It has a low incidence of movement-related side effects (extrapyramidal symptoms) and is considered safe for these uses, but specific safety data for postpartum depression is limited. ^{3 5 6 7 8}

How is the drug quetiapine unique for treating postpartum depression?

Quetiapine is unique for treating postpartum depression because it is an atypical antipsychotic that has shown effectiveness in treating mood disorders like bipolar disorder, which can include both manic and depressive episodes. This suggests it may help manage mood swings and depressive symptoms in postpartum depression, although its use in this specific condition is still being explored. ^{1 3 5 8 9}

Research Team

Verinder Sharma, MB

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Olanzapine and quetiapine in the prevention of a new mood episode in women with bipolar disorder during the postpartum period: a retrospective cohort study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of quetiapine off-label uses: data synthesis. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Quetiapine Excretion Into Human Breast Milk. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on quetiapine in bipolar depression. [2018]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on quetiapine in acute mania and depression associated with bipolar disorder. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Quetiapine safety in older adults: a systematic literature review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Quetiapine in patients with schizophrenia. A high- and low-dose double-blind comparison with placebo. Seroquel Study Group. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Quetiapine: a review of its use in acute mania and depression associated with bipolar disorder. [2018]

9. Hungary pubmed.ncbi.nlm.nih.gov

Extended release quetiapine fumarate and pregnancy. [2015]