A Pilot Study on the Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression
Overview
- Phase
- Phase 1
- Intervention
- Quetiapine
- Conditions
- Postpartum Depression
- Sponsor
- Verinder Sharma
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Recruitment and retention rate
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Verinder Sharma
Principal investigator
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
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
Arms & Interventions
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.
Intervention: Quetiapine
Outcomes
Primary Outcomes
Recruitment and retention rate
Time Frame: 10 weeks
Data on the recruitment rate, refusal rate, retention rate will be used to assess feasibility
Blood pressure
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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.
Fasting lipid panel test
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Waist circumference (cm) will help measure the safety of the intervention
Returned tablet count
Time Frame: 8 weeks
Adherence will be determined by returned tablet count.
Maternal functioning will be measured by the Barkin Index of Maternal Functioning (BIMF)
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Pulse will be measured in beats per minute
Body mass index
Time Frame: 8 weeks
Weight (km) and height (m) will be used to calculate BMI (kg/m\^2)
Secondary Outcomes
- Hamilton Depression Rating (HDRS) total score(8 weeks)
- Edinburgh Postnatal Depression Scale(8 weeks)
- Generalized Anxiety Disorder 7-item scale(8 weeks)
- Young Mania Rating Scale(8 weeks)