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

NCT04950868 | Active Not Recruiting Phase 1

• 1 other identifier: 118885
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Keywords

Quetiapine; postpartum; Drug therapy; Major depressive disorder

Outcome Measures

Primary Outcomes (10)

• Recruitment and retention rate

  Data on the recruitment rate, refusal rate, retention rate will be used to assess feasibility

  10 weeks

• Blood pressure

  The measurement of blood pressure (both systolic and diastolic blood pressure) will be measured in mm HG

  8 weeks

• 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

• 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

• Pulse

  Pulse will be measured in beats per minute

  8 weeks

• Body mass index

  Weight (km) and height (m) will be used to calculate BMI (kg/m\^2)

  8 weeks

• 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

• 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

• Waist circumference

  Waist circumference (cm) will help measure the safety of the intervention

  8 weeks

• Returned tablet count

  Adherence will be determined by returned tablet count.

  8 weeks

Secondary Outcomes (4)

• 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

Study Arms (1)

Quetiapine

EXPERIMENTAL

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.

Drug: Quetiapine

Interventions

Quetiapine DRUG

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.

Quetiapine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Verinder Sharma: lead

Study Sites (1)

Parkwood Institute

London, Ontario, N6C 5J1, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum; Depressive Disorder, Major

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Verinder Sharma, MB

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 6, 2021
• Study Start: March 18, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)