Clinical trial for Perinatal Depression
Official title Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome
ClinicalTrials.gov ID: NCT06074250
What this study is testing
- What it's testing
- The study wants to see if changing gut bacteria with diet, probiotics, or fish oil can affect depression and anxiety during pregnancy and after birth.
- Who it's for
- Pregnant women in their second trimester who have had depression or anxiety before.
- What's involved
- Participants will follow a diet plan and may take probiotics or fish oil, meet with the study team online every 3 months, fill out food and mood questionnaires, and send stool samples.
- Time commitment
- The study lasts about 1 year after delivery, with virtual visits every 3 months and regular questionnaires and stool sample collection.
- Phase 3: a large, late-stage study
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 43, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 43 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.