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New treatment option for Schizophrenia
Official title Prebiotic Treatment in People With Schizophrenia
ClinicalTrials.gov ID: NCT05527210
What this study is testing
- What it's testing
- The proposed project is based on the observation that schizophrenia is characterized by a chronic pro-inflammatory state, which contributes to the severity of a number of the clinical manifestations of the illness, including cognitive impairments, the treatment of which represents a critically important unmet therapeutic need.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 60
You may be able to join if
- DSM-5 diagnosis of schizophrenia or schizoaffective disorder;
- Age 18-60 years;
- Considered clinically stable by the treating psychiatrist;
- Currently treated with an antipsychotic, with no dose changes in last 14 days;
- Ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent;
You likely can't join if
- Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease, whose pathology or treatment...
- Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
- Intellectual disability
- Acute antibiotic use
- Immune therapy within the last three months
- Prebiotic or probiotic treatment within the last three months
See the full eligibility criteria
- DSM-5 diagnosis of schizophrenia or schizoaffective disorder;
- Age 18-60 years;
- Considered clinically stable by the treating psychiatrist;
- Currently treated with an antipsychotic, with no dose changes in last 14 days;
- Ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent;
- BMI ≤ 40
- Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease, whose pathology or treatment could alter the presentation or treatment of schizophrenia or...
- Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
- Intellectual disability
- Acute antibiotic use
- Immune therapy within the last three months
- Prebiotic or probiotic treatment within the last three months
- Inability to understand English
- Inability to cooperate with study procedures
- Pregnant or lactation secondary to pregnancy
- Participants who meet DSM 5 criteria for alcohol or substance misuse (except caffeine and nicotine) within the last 3 months will be excluded. Participants who meet DSM 5 criteria for marijuana misuse - mild will be...
The study team makes the final eligibility decision.
Where it's taking place
- Catonsville, Maryland, United States
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 - 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 all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Catonsville, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.