Fecal Transplant for Depression

Recruiting in Palo Alto (17 mi)

Overseen byValerie Taylor, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: University of Calgary

Prior Safety Data

Trial Summary

What is the purpose of this trial?The primary goals of this proof of concept clinical trial are to determine the effectiveness, safety and tolerability of oral FMT in adults with Treatment Resistant Depression (TRD).

Eligibility Criteria

Adults aged 18-65 with Major Depressive Disorder (MDD) who haven't improved after trying at least two antidepressants can join this trial. They must have a specific depression score (≥19 on the MADRS scale), be on stable antidepressant treatment for 8 weeks, and not use certain medications or have chronic gastrointestinal diseases, immune suppression, or severe psychiatric conditions.

Inclusion Criteria

I am between 18 and 65 years old.

I have been diagnosed with major depressive disorder (MDD).

+8 more

Exclusion Criteria

Conditions causing immune suppression

Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Criteria for the following conditions according to the M.I.N.I: f) Substance Use Disorder within the last 3 months (Criteria should include Alcohol and non-alcohol substances except Cannabis), g) Moderate or severe Substance use disorder for Cannabis use the last 3 months, h) Active Anorexia Nervosa or Bulimia nervosa, i) Schizophrenia or schizoaffective disorder, j) Active suicidality

I have a long-term gut condition like IBD, Crohn's, Ulcerative colitis, or Celiac disease.

+4 more

Participant Groups

The trial is testing if swallowing FMT oral capsules is safe and effective for treating Treatment Resistant Depression compared to placebo capsules. Participants are randomly given either the real treatment or a placebo to see if there's an improvement in their depression symptoms.

2Treatment groups

Active Control

Placebo Group

Group I: FMT capsulesActive Control1 Intervention

Each dose of FMT capsules consists of 20 capsules. The 20 over encapsulated capsules are derived from 100 grams of stool and each containing 0.67 ml of pelleted intestinal microbes. PArticipants will recieve a loading dose of 60 capsules over 3 consecutive days followed by a booster dose of 20 caspules 1 month after and a second similar booster dose a month after that

Group II: Placebo oral CapsulesPlacebo Group1 Intervention

Placebo casules are inactive capsules that look and weigh the same as the Active FMT caspules. Participants will follow the same schedule as the Active arm.