50 Participants Needed

Quetiapine vs Trazodone for Postpartum Depression

Age: 18 - 65
Sex: Female
Trial Phase: Phase < 1
Sponsor: Lawson Health Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drugs Quetiapine and Trazodone for postpartum depression?

There is no direct evidence from the provided research articles supporting the effectiveness of Quetiapine or Trazodone specifically for postpartum depression. However, Quetiapine has been studied for preventing mood episodes in women with bipolar disorder during the postpartum period, suggesting it may have some mood-stabilizing effects.12345

Is quetiapine safe for use during breastfeeding?

There is limited data on the safety of quetiapine during breastfeeding, making risk assessment challenging. It has been associated with increased risk of serotonin syndrome when combined with other serotonergic drugs.25678

How does the drug Quetiapine differ from other treatments for postpartum depression?

Quetiapine is unique because it is an atypical antipsychotic that is also used to treat bipolar depression, offering potential benefits for postpartum depression by improving depressive and anxiety symptoms. Unlike some other antidepressants, it is not associated with an increased risk of treatment-emergent mania, which may make it a suitable option for postpartum depression.123910

What is the purpose of this trial?

Postpartum depression is a serious disorder that affects approximately 17% of women who have recently given birth. Untreated postpartum depression can negatively affect the mother, the infant, and the family. Lack of sleep is common after delivery and can trigger or worsen depression in some women. Trazodone is used for sleeplessness and depression, but it has not been studied for postpartum depression. There is preliminary evidence that quetiapine, another drug used for depression and sleeplessness, may be effective for postpartum depression. We are planning a study to compare the effectiveness and side effects of quetiapine and trazodone in women with postpartum depression. The results of this study will help us carry out larger studies comparing these drugs with a placebo (a sugar pill) in postpartum depression. We expect the results of our study will improve the mental health of mothers and the well-being of their babies and make it easier for healthcare staff to select the right drug for women with postpartum depression.

Eligibility Criteria

This trial is for women who have recently given birth and are experiencing postpartum depression. Participants should not have been treated yet for their condition. The study aims to help those struggling with sleeplessness and depressive symptoms after delivery.

Inclusion Criteria

Can communicate in English
Can provide informed consent
I am 18-45, had a baby within the last 6 months, and have been diagnosed with depression starting around the time of birth.

Exclusion Criteria

I am a woman diagnosed with bipolar disorder or a similar condition.
I have been diagnosed with schizophrenia or a similar psychotic disorder.
Women at high risk for suicide (actively suicidal or with a score of ≥ 3 on item #3 on the HDRS)
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either trazodone or quetiapine with dose adjustments over 8 weeks

8 weeks
Visits at weeks 1, 2, 4, 6, and 8

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

4 weeks

Treatment Details

Interventions

  • Quetiapine
  • Trazodone
Trial Overview The study is comparing the effectiveness of two drugs, Quetiapine and Trazodone, in treating postpartum depression. It will assess which drug better improves mental health outcomes for new mothers suffering from this condition.
Participant Groups
2Treatment groups
Active Control
Group I: QuetiapineActive Control1 Intervention
Participants will be started on trazodone 12.5 mg or quetiapine 6.25 mg in identical opaque gelatin capsules at bedtime. The doses will be increased to a maximum of 50 mg for trazodone and 25 mg for quetiapine.
Group II: TrazadoneActive Control1 Intervention
Participants will be started on trazodone 12.5 mg or quetiapine 6.25 mg in identical opaque gelatin capsules at bedtime. The doses will be increased to a maximum of 50 mg for trazodone and 25 mg for quetiapine.

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials
684
Recruited
432,000+

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

Lead Sponsor

Trials
668
Recruited
424,000+

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

Lead Sponsor

Trials
686
Recruited
427,000+

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

Lead Sponsor

Trials
678
Recruited
421,000+

References

Agomelatine for postpartum depression and breastfeeding. [2021]
Short-Term Safety of Paroxetine Plus Low-Dose Mirtazapine During Lactation. [2022]
Comparative efficacy and acceptability of pharmacotherapies for postpartum depression: A systematic review and network meta-analysis. [2022]
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]
Gastrointestinal Side Effects in the Baby of a Breastfeeding Woman Treated with Low-Dose Fluvoxamine. [2022]
Quetiapine Excretion Into Human Breast Milk. [2018]
Why the Maternal Medication List Matters: Neonatal Toxicity From Combined Serotonergic Exposures. [2021]
Use of contemporary antidepressants during breastfeeding: a proposal for a specific safety index. [2022]
Spotlight on quetiapine in bipolar depression. [2018]
Overcoming functional impairment in postpartum depressed or anxious women: a pilot trial of desvenlafaxine with flexible dosing. [2020]
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