Status:
RECRUITING
Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome
Lead Sponsor:
The Canadian College of Naturopathic Medicine
Collaborating Sponsors:
Sunnybrook Health Sciences Centre
Lotte & John Hecht Memorial Foundation
Conditions:
Perinatal Depression
PerinatalAnxiety
Eligibility:
FEMALE
18-43 years
Phase:
PHASE2
PHASE3
Brief Summary
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 pregnanci...
Detailed Description
Pregnant women with a history of anxiety and/or depression \& currently stable, will be recruited and randomized or assigned to one of four study groups. A total of 100 will be recruited and required ...
Eligibility Criteria
Inclusion
- 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 (unable to afford basic daily needs (i.e., shelter, food, etc.)
- Diagnosis with other major mental health disorders (Bipolar, Psychosis, Addiction, Schizophrenia);
- Diagnosis with other severe medical conditions (i.e. epilepsy, neurological disorders, etc.)
- Allergies to fish oils/ingredients in supplements
- Conditions that require repeated/chronic antibiotic usage
- Having a child with significant mental/physical disability
- Single mothers without any kind of family support,
- Cigarette, alcohol and recreational drug users
- Women unwilling to switch to study product(s)
- Multiparous women with young children (i.e. one or more children less than 4 years of age at the time of delivery)
- Non-English Readers/Speakers
Exclusion
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06074250
Start Date
August 15 2024
End Date
March 1 2028
Last Update
August 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sunnybrook Health Science Center
Toronto, Ontario, Canada, M4N 3M5