Back to resultsThe Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression
Primary Purpose
Postpartum Depression
Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Quetiapine
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Depression focused on measuring Quetiapine, postpartum, Drug therapy, Major depressive disorder
Eligibility Criteria
Inclusion Criteria:
- Outpatient woman between ages 18 - 45
- Within 6 months of delivery
- Have a DSM-5 diagnosis of MDD or BD I, BD II or other specified bipolar or related disorder with peripartum onset
- Have a score of >18 on the 17-item Hamilton Depression Rating Scale (HDRS)
- Have a score of ≤12 Young Mania Rating Scale (YMRS) at both the screening and baseline visits
- Able to communicate in English
- Capable of providing informed consent
Exclusion Criteria:
- 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)
- Receiving a psychotropic drug such a mood stabilizer, an antidepressant or a sedative/hypnotic.
- Receiving psychotherapy
- Have a physical illness that is a contraindication to the use of quetiapine, or who have a history of intolerance or nonresponse to quetiapine
- Pregnant or planning on becoming pregnant during the study
Sites / Locations
- Parkwood InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Quetiapine
Arm Description
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.
Outcomes
Primary Outcome Measures
Recruitment and retention rate
Data on the recruitment rate, refusal rate, retention rate will be used to assess feasibility
Blood pressure
The measurement of blood pressure (both systolic and diastolic blood pressure) will be measured in mm HG
Incidence of Treatment-Emergent Adverse Events as assessed by the Systematic Monitoring of Adverse events Related to TreatmentS (SMARTS) score
The Systematic Monitoring of Adverse events Related to TreatmentS (SMARTS), will be used to gather information about side effects of quetiapine. It is a check list to identify potential side effects.
Maternal functioning will be measured by the Barkin Index of Maternal Functioning (BIMF)
Tolerability described as the degree to which overt adverse effects are tolerated, will be measured using the Barkin Index of Maternal Functioning (BIMF). The Barkin Index of Maternal Functioning score from baseline to week 8 will also be assessed. The sum of the scores is calculated, ranging from 0 to 120. Where a score of 120 means perfect functioning. The different between the scores scores will be looked at and a more positive score (8 week score is greater than baseline score) is a better outcome.
Pulse
Pulse will be measured in beats per minute
Body mass index
Weight (km) and height (m) will be used to calculate BMI (kg/m^2)
Fasting lipid panel test
The fasting lipid panel will be completed to measure safety of the intervention. This measures lipid levels (Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides). All measured in mg/dL
glycated haemoglobin (HbA1c) tests
Glycated haemoglobin (HbA1C) test will be done to measure glycated haemoglobin which will measure the safety of the intervention. It will be measured in mmol/mol and as a percentage.
Waist circumference
Waist circumference (cm) will help measure the safety of the intervention
Returned tablet count
Adherence will be determined by returned tablet count.
Secondary Outcome Measures
Hamilton Depression Rating (HDRS) total score
Secondary outcome will be the mean change from baseline to week 8 in the Hamilton Depression Rating (HDRS) total score, the proportion of participants achieving response (≥50% reduction in HDRS score at baseline) and the proportion of participants achieving remission (HDRS ≤12). The score ranges from 0-53 where a higher score is a worse outcome.
Edinburgh Postnatal Depression Scale
The mean change in scores of Edinburgh Postnatal Depression Scale. The scores range from 0 to 30 with 30 indicating more depression symptoms.
Generalized Anxiety Disorder 7-item scale
The mean change in scores of Generalized Anxiety Disorder 7-item scale. The scores range from 0 to 21. A higher generalized anxiety score indicates higher anxiety and indicating a worse outcome.
Young Mania Rating Scale
The mean change in scores of Young Mania Rating Scale. The YMRS is a rating scale used to evaluate manic symptoms at baseline and over time in individuals with mania. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others. The score ranges from 0 to 60 where 60 indicates a worse outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04950868
Brief Title
The Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression
Official Title
A Pilot Study on the Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Verinder Sharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Postpartum depression is a serious disorder that affects approximately 14% of women who have recently given birth. Postpartum depression is either an episode of major depressive disorder (only low periods) or bipolar disorder (periods of lows and highs).
Untreated postpartum depression can negatively affect the mother, the infant and the family. Antidepressants are the most used treatments; however, for many women these drugs are not useful, resulting in a pressing need for effective treatments for postpartum depression. Lack of sleep is common after delivery and can trigger depression in some women. Quetiapine, a drug used for bipolar disorder, major depressive disorder and occasionally sleeplessness has not been well studied in postpartum depression. This study aims to find out how mothers tolerate the drug and whether it is effective for postpartum depression. Results of this study may help investigators carry out a larger study comparing quetiapine and placebo (a sugar pill) in postpartum depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Quetiapine, postpartum, Drug therapy, Major depressive disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quetiapine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment and retention rate
Description
Data on the recruitment rate, refusal rate, retention rate will be used to assess feasibility
Time Frame
10 weeks
Title
Blood pressure
Description
The measurement of blood pressure (both systolic and diastolic blood pressure) will be measured in mm HG
Time Frame
8 weeks
Title
Incidence of Treatment-Emergent Adverse Events as assessed by the Systematic Monitoring of Adverse events Related to TreatmentS (SMARTS) score
Description
The Systematic Monitoring of Adverse events Related to TreatmentS (SMARTS), will be used to gather information about side effects of quetiapine. It is a check list to identify potential side effects.
Time Frame
8 weeks
Title
Maternal functioning will be measured by the Barkin Index of Maternal Functioning (BIMF)
Description
Tolerability described as the degree to which overt adverse effects are tolerated, will be measured using the Barkin Index of Maternal Functioning (BIMF). The Barkin Index of Maternal Functioning score from baseline to week 8 will also be assessed. The sum of the scores is calculated, ranging from 0 to 120. Where a score of 120 means perfect functioning. The different between the scores scores will be looked at and a more positive score (8 week score is greater than baseline score) is a better outcome.
Time Frame
8 weeks
Title
Pulse
Description
Pulse will be measured in beats per minute
Time Frame
8 weeks
Title
Body mass index
Description
Weight (km) and height (m) will be used to calculate BMI (kg/m^2)
Time Frame
8 weeks
Title
Fasting lipid panel test
Description
The fasting lipid panel will be completed to measure safety of the intervention. This measures lipid levels (Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides). All measured in mg/dL
Time Frame
8 weeks
Title
glycated haemoglobin (HbA1c) tests
Description
Glycated haemoglobin (HbA1C) test will be done to measure glycated haemoglobin which will measure the safety of the intervention. It will be measured in mmol/mol and as a percentage.
Time Frame
8 weeks
Title
Waist circumference
Description
Waist circumference (cm) will help measure the safety of the intervention
Time Frame
8 weeks
Title
Returned tablet count
Description
Adherence will be determined by returned tablet count.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating (HDRS) total score
Description
Secondary outcome will be the mean change from baseline to week 8 in the Hamilton Depression Rating (HDRS) total score, the proportion of participants achieving response (≥50% reduction in HDRS score at baseline) and the proportion of participants achieving remission (HDRS ≤12). The score ranges from 0-53 where a higher score is a worse outcome.
Time Frame
8 weeks
Title
Edinburgh Postnatal Depression Scale
Description
The mean change in scores of Edinburgh Postnatal Depression Scale. The scores range from 0 to 30 with 30 indicating more depression symptoms.
Time Frame
8 weeks
Title
Generalized Anxiety Disorder 7-item scale
Description
The mean change in scores of Generalized Anxiety Disorder 7-item scale. The scores range from 0 to 21. A higher generalized anxiety score indicates higher anxiety and indicating a worse outcome.
Time Frame
8 weeks
Title
Young Mania Rating Scale
Description
The mean change in scores of Young Mania Rating Scale. The YMRS is a rating scale used to evaluate manic symptoms at baseline and over time in individuals with mania. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others. The score ranges from 0 to 60 where 60 indicates a worse outcome.
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Outpatient woman between ages 18 - 45
Within 6 months of delivery
Have a DSM-5 diagnosis of MDD or BD I, BD II or other specified bipolar or related disorder with peripartum onset
Have a score of >18 on the 17-item Hamilton Depression Rating Scale (HDRS)
Have a score of ≤12 Young Mania Rating Scale (YMRS) at both the screening and baseline visits
Able to communicate in English
Capable of providing informed consent
Exclusion Criteria:
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)
Receiving a psychotropic drug such a mood stabilizer, an antidepressant or a sedative/hypnotic.
Receiving psychotherapy
Have a physical illness that is a contraindication to the use of quetiapine, or who have a history of intolerance or nonresponse to quetiapine
Pregnant or planning on becoming pregnant during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Verinder Sharma, MB
Phone
519-455-5110
Ext
47392
Email
vsharma@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Verinder Sharma, MB
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkwood Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Verinder Sharma, MB BS
Phone
519-455-5110
Ext
47392
Email
vsharma@uwo.ca
First Name & Middle Initial & Last Name & Degree
Verinder Sharma, MB BS
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There will be no sharing plan needed because no individual participant data (IPD) will be available to other researchers.
Learn more about this trial
The Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression
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