Quetiapine Versus Trazadone in Women With Postpartum Depression

NCT06546358 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 125638
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum depression is a serious disorder that affects approximately 17% of women who have recently given birth. Untreated postpartum depression can negatively affect the mother, the infant, and the family. Lack of sleep is common after delivery and can trigger or worsen depression in some women. Trazodone is used for sleeplessness and depression, but it has not been studied for postpartum depression. There is preliminary evidence that quetiapine, another drug used for depression and sleeplessness, may be effective for postpartum depression. We are planning a study to compare the effectiveness and side effects of quetiapine and trazodone in women with postpartum depression. The results of this study will help us carry out larger studies comparing these drugs with a placebo (a sugar pill) in postpartum depression. We expect the results of our study will improve the mental health of mothers and the well-being of their babies and make it easier for healthcare staff to select the right drug for women with postpartum depression.

Conditions

Postpartum Depression

Keywords

postpartum depression; trazadone; quetiapine

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale

  The primary outcome will be the mean change from baseline to week 8 in the 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).

  8 weeks

Study Arms (2)

Trazadone

ACTIVE COMPARATOR

Participants will be started on trazodone 12.5 mg or quetiapine 6.25 mg in identical opaque gelatin capsules at bedtime. The doses will be increased to a maximum of 50 mg for trazodone and 25 mg for quetiapine.

Drug: Trazodone

Quetiapine

ACTIVE COMPARATOR

Participants will be started on trazodone 12.5 mg or quetiapine 6.25 mg in identical opaque gelatin capsules at bedtime. The doses will be increased to a maximum of 50 mg for trazodone and 25 mg for quetiapine.

Drug: Quetiapine

Interventions

Trazodone DRUG

Participants will be randomized to receive either quetiapine or trazodone.

Also known as: Teva-Trazadone

Trazadone

Quetiapine DRUG

Participants will be randomized to receive either quetiapine or trazodone.

Also known as: Quetiapine Fumarate

Quetiapine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women will be recruited who have given birth within the last 6 months.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Outpatients between ages 18 and 45 years who are within 6 months of delivering a child and have a DSM-5-TR diagnosis of major depressive disorder (MDD) with peripartum onset, a 17-item Hamilton Depression Rating Scale (HDRS) score of \>18 at both the screening and baseline visits, can communicate in English, and can provide informed consent will be included.

You may not qualify if:

• Women with schizophrenia spectrum or other psychotic disorders, bipolar and related disorders, eating disorders, substance-related and addictive disorders; and those at high risk for suicide (actively suicidal or with a score of ≥ 3 on item #3 on the HDRS) will be excluded. Women with a physical illness that is a contraindication to the use of quetiapine, or who have a history of intolerance or nonresponse to quetiapine will also be excluded.

Sponsors & Collaborators

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

Study Sites (1)

Parkwood Institute

London, Ontario, N6V 0A7, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Trazodone; 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)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Pharmacy will randomize and dispense medication. Participants will be started on trazodone 12.5 mg or quetiapine 6.25 mg in identical opaque gelatin capsules at bedtime.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to treatment with trazodone or quetiapine in blocks of 8 with a sequence generated by SPSS.

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CA (1)