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Atypical Antipsychotic
Quetiapine for Postpartum Depression
Phase 1
Recruiting
Led By Verinder Sharma, MB
Research Sponsored by Verinder Sharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capable of providing informed consent
Have a DSM-5 diagnosis of MDD or BD I, BD II or other specified bipolar or related disorder with peripartum onset
Must not have
Receiving a psychotropic drug such a mood stabilizer, an antidepressant or a sedative/hypnotic
Have a physical illness that is a contraindication to the use of quetiapine, or who have a history of intolerance or nonresponse to quetiapine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
No Placebo-Only Group
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Quetiapine can cause side effects such as drowsiness, dry mouth, dizziness, constipation, weight gain, blurred vision or restlessness. More serious side effects might include changes in mood or behavior.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to understand and agree to the study's procedures.
Select...
I have been diagnosed with major depression or bipolar disorder related to childbirth.
Select...
I am a woman aged between 18 and 45.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication for my mood, depression, or sleep.
Select...
I cannot take quetiapine due to a physical illness, intolerance, or it didn't work for me.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood pressure
Body mass index
Fasting lipid panel test
+7 moreSecondary study objectives
Edinburgh Postnatal Depression Scale
Generalized Anxiety Disorder 7-item scale
Hamilton Depression Rating (HDRS) total score
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: QuetiapineExperimental Treatment1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quetiapine
2003
Completed Phase 4
~3220
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Postpartum Depression (PPD) treatments often involve medications that modulate neurotransmitter activity, particularly serotonin and dopamine, to alleviate depressive symptoms. Selective serotonin reuptake inhibitors (SSRIs) increase serotonin levels in the brain, improving mood and emotional stability.
Atypical antipsychotics like Quetiapine not only affect serotonin but also dopamine pathways, which can help manage both depressive and psychotic symptoms. This dual modulation is crucial for PPD patients as it addresses the complex interplay of mood and cognitive functions, potentially offering more comprehensive symptom relief.
8-OH-DPAT enhances dopamine D<sub>2</sub>-induced maternal disruption in rats.[Challenge abstinence-a case report and overview on therapy of alcohol dependence during pregnancy].
8-OH-DPAT enhances dopamine D<sub>2</sub>-induced maternal disruption in rats.[Challenge abstinence-a case report and overview on therapy of alcohol dependence during pregnancy].
Find a Location
Who is running the clinical trial?
Verinder SharmaLead Sponsor
1 Previous Clinical Trials
28 Total Patients Enrolled
1 Trials studying Postpartum Depression
28 Patients Enrolled for Postpartum Depression
Verinder Sharma, MBPrincipal InvestigatorLawson Health Research Institute
1 Previous Clinical Trials
28 Total Patients Enrolled
1 Trials studying Postpartum Depression
28 Patients Enrolled for Postpartum Depression
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to understand and agree to the study's procedures.I am currently taking medication for my mood, depression, or sleep.I have been diagnosed with major depression or bipolar disorder related to childbirth.I cannot take quetiapine due to a physical illness, intolerance, or it didn't work for me.I am a woman aged between 18 and 45.I am currently undergoing psychotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Quetiapine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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