The Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression

Postpartum Depression Clinical Trial

Official title:

A Pilot Study on the Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04950868
• Other study ID #: 118885
• Status: Recruiting
• Phase: Phase 1
• Start date: March 18, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2022
• Source: Lawson Health Research Institute
• Contact: Verinder Sharma, MB
• Phone: 519-455-5110
• Email: vsharma[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Drug:
• Quetiapine
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.

Locations

Country	Name	City	State
Canada	Parkwood Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Verinder Sharma

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment and retention rate	Data on the recruitment rate, refusal rate, retention rate will be used to assess feasibility	10 weeks
Primary	Blood pressure	The measurement of blood pressure (both systolic and diastolic blood pressure) will be measured in mm HG	8 weeks
Primary	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.	8 weeks
Primary	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.	8 weeks
Primary	Pulse	Pulse will be measured in beats per minute	8 weeks
Primary	Body mass index	Weight (km) and height (m) will be used to calculate BMI (kg/m^2)	8 weeks
Primary	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	8 weeks
Primary	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.	8 weeks
Primary	Waist circumference	Waist circumference (cm) will help measure the safety of the intervention	8 weeks
Primary	Returned tablet count	Adherence will be determined by returned tablet count.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks