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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Study Summary

This trial is testing whether the drug quetiapine can help treat postpartum depression.

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.Check my eligibility
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.See study design
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 below
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I am able to understand and agree to the study's procedures.
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I have been diagnosed with major depression or bipolar disorder related to childbirth.
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I am a woman aged between 18 and 45.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood pressure
Body mass index
Fasting lipid panel test
+7 more
Secondary outcome measures
Edinburgh Postnatal Depression Scale
Generalized Anxiety Disorder 7-item scale
Hamilton Depression Rating (HDRS) total score
+1 more

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

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

Media Library

Quetiapine (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT04950868 — Phase 1
Postpartum Depression Research Study Groups: Quetiapine
Postpartum Depression Clinical Trial 2023: Quetiapine Highlights & Side Effects. Trial Name: NCT04950868 — Phase 1
Quetiapine (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04950868 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What afflictions has Quetiapine been proven to alleviate?

"Quetiapine is a commonly prescribed medication for treating anxiety disorders, but its application extends to acute coryza, mental depression and even bipolar disorder."

Answered by AI

What is the anticipated enrollment size for this investigation?

"Affirmative. The clinicaltrials.gov website illustrates that this study is presently recruiting patients, which were first advertised on March 18th 2022 and updated for the last time on the same date. A total of 30 participants are needed from a single medical facility."

Answered by AI

Is Quetiapine a reliable and secure option for people?

"Quetiapine's safety rating is 1, as this Phase 1 trial has only yielded limited data regarding the drug's efficacy and security."

Answered by AI

Can you provide a summary of the history and outcomes surrounding trials involving Quetiapine?

"Currently, there are 13 ongoing clinical tests of Quetiapine with 3 trials in their final stage. Most research is based around Bhubaneswar, Orissa but the drug is also being studied across 419 facilities."

Answered by AI

What are the criteria for joining this clinical investigation?

"This clinical trial seeks 30 participants, aged 18-45 years old and diagnosed with depression. To be eligible for participation, potential patients must also have a DSM-5 diagnosis of Major Depressive Disorder (MDD) or Bipolar I & II; present scores >18 on the 17-item Hamilton Depression Rating Scale (HDRS), ≤12 Young Mania Rating Scale (YMRS); had delivery within 6 months prior to enrollment; and are outpatient women."

Answered by AI

What are the fundamental goals of this medical trial?

"This 8-week trial seeks to measure the effects of glycated haemoglobin (HbA1c) tests. Secondary outcomes will be evaluated via three separate scales: Generalized Anxiety Disorder 7-item scale (with scores ranging from 0 to 21, with higher numbers indicating heightened anxiety), Edinburgh Postnatal Depression Scale (scores range from 0 to 30, where a score closer to 30 signifies greater depression symptoms,) and Young Mania Rating Scale which consists of four items given twice the weight as seven others graded on a 0 - 8 scale; this yields an aggregate total between 0 and 60, wherein 60 indicates poorer results."

Answered by AI

Is enrollment open at this time for the trial?

"Evidenced by clinicaltrials.gov, this study is actively hunting for participants. This medical experiment was first made available on March 18th 2022 and has been revised since that date."

Answered by AI

Does the trial recruitment process accept individuals of advanced age?

"The enrollment criteria for this study is adults aged between 18-45 years old. There are 196 trials targeting minors and 977 studies that involve seniors over 65."

Answered by AI

Could you please explain if this is an innovative trial?

"Otsuka America Pharmaceutical first launched a clinical trial for Quetiapine in 2014, involving 200 participants. After this successful study, the drug was granted Phase 4 approval and currently there are 13 ongoing trials across 138 cities and 27 countries."

Answered by AI
~10 spots leftby Mar 2025