Depression in Schizophrenia Clinical Trial
Official title:
FEcal Microbiota Transplantation for MAjor Depression in Schizophrenia (FEMADSZ)
The primary objective will be to evaluate effectiveness, safety and acceptability of FMT on depressive symptoms at 2 months follow-up in SZ patients with resistant MD.
Background. Major Depression (MD) will move into the first place of cause of the global
burden of disease by 2030. Conventional treatments (antidepressants) are only partly
effective with frequent side effects. More specifically, MD is underdiagnosed and
undertreated in schizophrenia (SZ) despite its high impact on prognosis and quality of life
in SZ patients. Even when treated, 44% of the patients remain major depressed under
conventional antidepressants.
FEMADSZ makes the hypothesis that this is due to the fact that the source of MD relies
outside the brain, in the gut microbiota. The associations between microbiota disturbances
are now well demonstrated in rodent models (>60 studies) and indirect data in humans clearly
suggest that the microbiota hypothesis of MD is the most promising track in psychiatry. The
primary objective will be to evaluate effectiveness, safety and acceptability of FMT on
depressive symptoms at 2 months follow-up in SZ patients with resistant MD. Methods: This is
a pilot, single-arm, prospective, open-label proof-of-concept trial, including SZ patients
with resistant MD. Fifteen patients will be enrolled and administered a Fecal Microbiota
Transplantation. The main outcome measure will be depressive score at 2 months, adverse
events and acceptability. Each patient will receive a FDG-PET scan, a routine blood draw and
a metagenomic microbiota analysis before and after intervention. Expected results. This pilot
study will help determining the effectiveness of FMT and the neurobiologic and microbiologic
mechanisms associated with response to treatment.
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