Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome

Recruiting Phase 2 Phase 3 Interventional Study
Perinatal Depression PerinatalAnxiety
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 43
Sex
Female
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Prevention
Participants needed
100 (estimated)
Sponsor
The Canadian College of Naturopathic Medicine · Other
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About This Trial
Perinatal depression and anxiety (PDA) are the leading causes of maternal mortality in developed countries. Women with a history of depression have a 20 fold higher risk of PDA at subsequent pregnancies. The adverse outcomes extend beyond maternal well-being to long-term deficits in children and families. The gut-brain axis is a newly recognized key player in mental health disorders. Specifically,…
Trial Locations
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Eligibility Criteria
Inclusion Criteria * Women 18-43 years old * 12-35 weeks of gestation * Non-smoker/alcohol/recreational drug user * Financially stable * Clinical diagnosis of lifetime depression/anxiety or PDA but currently well * English speaking Exclusion Criteria: * Body Mass Index (BMI)≥30 * Low income (unab…
Contacts

Neda Ebrahimi, PhD

416-498-1255

nebrahimi@ccnm.edu

CONTACT

Sophie Grigoriadis, MD

416-480-5677

sophie.grigoriadis@sunnybrook.ca

CONTACT