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NCT05299398
Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone
Phase 1 trial testing Trazodone in Postpartum Depression. Withdrawn.
31 August 2025
Quick facts
| Lead sponsor | Verinder Sharma |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Start date | 17 April 2025 |
| Primary completion | 31 August 2025 |
| Estimated completion | 31 August 2025 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Trazodone (trazodone) — full drug profile →
- Placebo
Conditions studied
- Postpartum Depression — all drugs for Postpartum Depression →
Sponsor
Verinder Sharma
Who can join
Adults 18 to 45, female only, with Postpartum Depression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Postpartum depression is a serious illness that affects approximately 17% of women who have recently given birth. Untreated depression appears to have negative effects for both the mother and her baby. Postpartum depression is quite common among women with a history of depression. Sleeplessness is a common concern during pregnancy and after delivery, and it can also trigger depression in women with a history of depression. Antidepressants are the most commonly recommended drugs for prevention of postpartum depression; however, there is limited research to understand the effectiveness of the medications in preventing postpartum depression. Trazodone is a weak antidepressant, but it is commonly prescribed for sleeplessness due to physical or psychiatric disorders. We are planning a study to find out whether trazodone in a low dose is more effective than a sugar pill in preventing postpartum depression among women with histories of depression. We expect the results of our study will make it easier for healthcare providers to select the right medication for women who are at risk of developing depression after delivery and thus improve the mental health of mothers and well-being of their babies.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05299398
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Trazodone
Trials testing the same drug.
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- NCT06281756 — Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia · EARLY_PHASE1 · recruiting
- NCT05293600 — Rescue Pharmacotherapy for OSA · Phase 1, PHASE2 · recruiting
- NCT05282550 — Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone · Phase 2 · recruiting
- NCT05209035 — Evaluation of Trazodone in OSA-MCI · Phase 4 · active not recruiting
Other recruiting trials for Postpartum Depression
Currently open trials in the same condition.
- NCT07398469 — A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone · recruiting
- NCT06442774 — MamaConecta: Digital Tool for Maternal Mental Health · NA · recruiting
- NCT06545760 — Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression · NA · recruiting
- NCT05763537 — Understanding the Role of Doulas in Supporting People With PMADs · NA · recruiting
- NCT06462638 — COntact RElationship in Neonatal Intensive Care Unit · recruiting
Other Verinder Sharma trials
Trials by the same sponsor.
- NCT04950868 — The Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression · Phase 1 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05299398 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Verinder Sharma
- Last refreshed: 4 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05299398.
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