Clinical trial NCT04950868: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Postpartum Depression
Keywords: Quetiapine
postpartum
Drug therapy
Major depressive disorder
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Recruitment and retention rate
timeFrame: 10 weeks
measure: Blood pressure
timeFrame: 8 weeks
measure: Incidence of Treatment-Emergent Adverse Events as assessed by the Systematic Monitoring of Adverse events Related to TreatmentS (SMARTS) score
timeFrame: 8 weeks
measure: Maternal functioning will be measured by the Barkin Index of Maternal Functioning (BIMF)
timeFrame: 8 weeks
measure: Pulse
timeFrame: 8 weeks
measure: Body mass index
timeFrame: 8 weeks
measure: Fasting lipid panel test
timeFrame: 8 weeks
measure: glycated haemoglobin (HbA1c) tests
timeFrame: 8 weeks
measure: Waist circumference
timeFrame: 8 weeks
measure: Returned tablet count
timeFrame: 8 weeks
Secondary outcomes:
measure: Hamilton Depression Rating (HDRS) total score
timeFrame: 8 weeks
measure: Edinburgh Postnatal Depression Scale
timeFrame: 8 weeks
measure: Generalized Anxiety Disorder 7-item scale
timeFrame: 8 weeks
measure: Young Mania Rating Scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: Parkwood Institute
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Verinder Sharma, MB
role: PRINCIPAL_INVESTIGATOR
References: