Quetiapine vs Trazodone for Postpartum Depression

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: Lawson Health Research Institute

Disqualifiers: Schizophrenia, Bipolar, Eating disorders, others

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

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how two drugs, quetiapine (Seroquel) and trazodone, assist with postpartum depression, a condition affecting many new mothers. Postpartum depression can worsen with lack of sleep, and both drugs are known to aid sleep and mood, but they are being tested specifically for this condition. Participants will receive one of the drugs to compare their effectiveness and side effects. Women who have had a baby in the last six months and are experiencing major depression might be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how these treatments work in people, offering participants a chance to contribute to groundbreaking research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that quetiapine is usually well-tolerated, with most people not experiencing serious side effects. Studies have found it rarely causes movement-related issues like tremors or stiffness. Additionally, there is no known risk of major birth defects or other serious problems for mothers or babies. However, specific safety information about using quetiapine for postpartum depression remains limited.

Trazodone is often used to help with sleep problems and depression. Although it hasn't been specifically studied for postpartum depression, it is commonly used to treat insomnia and anxiety, which many new mothers experience. Direct safety information for postpartum use is limited, but it is often prescribed for sleep issues during pregnancy and breastfeeding.

Both medications are in the early stages of being studied for treating postpartum depression. Much remains to be learned about their safety and effectiveness for this specific use. Participants should consider this information and consult healthcare professionals when deciding whether to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for postpartum depression because they offer a potentially faster and more targeted approach than traditional options. While most standard treatments, like selective serotonin reuptake inhibitors (SSRIs), can take weeks to have an effect, quetiapine and trazodone might work more quickly due to their unique mechanisms. Quetiapine targets multiple neurotransmitter systems, potentially providing mood stabilization and better sleep. Trazodone, on the other hand, is known for its sedative properties and might improve sleep quality, which is often disrupted in postpartum depression. Both drugs could offer new hope for quicker relief during a challenging time for new mothers.

What evidence suggests that this trial's treatments could be effective for postpartum depression?

In this trial, participants will receive either quetiapine or trazodone to evaluate their effectiveness for postpartum depression. Research has shown that quetiapine might alleviate postpartum depression. Specifically, studies found that individuals taking quetiapine experienced fewer depression symptoms compared to those taking a placebo, which contains no active medicine. This indicates that quetiapine could be beneficial for postpartum depression. For trazodone, direct evidence for postpartum depression is limited. However, trazodone is known to aid with sleep and depression, which are significant concerns in postpartum depression. This trial studies both treatments to assess their effectiveness for this condition. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Women at high risk for suicide (actively suicidal or with a score of ≥ 3 on item #3 on the HDRS)

I have a health condition that makes it unsafe for me to use quetiapine.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Quetiapine Active Control 1 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: Trazadone Active Control 1 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

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+

Citations

1. 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, ...

2. 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 ...

3. 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

4. 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, ...

5. 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 ...

6. 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).

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00681668

NCT00681668 | Quetiapine in Postpartum Depression A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the ...