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.
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