Last updated: April 19, 2023
Sponsor: Sheppard Pratt Health System
Overall Status: Active - Recruiting
Phase
2
Condition
Schizophrenia And Schizoaffective Disorders (Pediatric)
Tourette's Syndrome
Mood Disorders
Treatment
N/AClinical Study ID
NCT04226898
SMRI/SPHS: 2020-01
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18-65, inclusive.
- Capacity for written informed consent.
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosisof schizophrenia or schizoaffective disorder (APA 2013) as determined by theStructured Clinical Interview for DSM-5 Disorders (SCID-5).
- Outpatient at the time of enrollment.
- Residual psychotic symptoms of at least moderate severity as evidenced by a Positiveand Negative Syndrome Scale (Kay et al., 1987) (PANSS) total score of 60 or higher ANDone or more of the following: one or more PANSS positive symptom scores of 4 orhigher; OR containing at least three positive or negative items with scores of 3 orhigher at the screening visit.
- Receiving antipsychotic medication for at least 8 weeks prior to starting the studywith no medication changes within the previous 21 days.
- Proficient in the English language.
Exclusion
Exclusion Criteria:
- DSM-5 diagnosis of intellectual disability or comparable diagnosis determined byprevious versions of the DSM.
- Any clinically significant or unstable medical disorder as determined by theinvestigators, including congestive heart failure, liver disease, renal failure, anydiagnosis of cancer undergoing active treatment.
- A primary immunodeficiency condition such as HIV infection, or undergoing cancerchemotherapy, or receiving systemic corticosteroids, methotrexate or monoclonalantibodies for treatment of an autoimmune disorder.
- History of IV drug use.
- DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine ortobacco, within the last three months prior to the screening visit. If the patient hasa positive drug toxicity screen at the time of visit 1 (screening) further evaluationby the investigator will be done of the substance use to determine eligibility.
- Participated in any investigational drug trial in the past 30 days.
- Pregnant or planning to become pregnant during the study period.
- Receipt of antibiotic medication within the 14 days prior to visit 2 (as anaerobicorganisms residing in the gastrointestinal tract may be minimally affected byantibiotics). Of note, patients on antibiotic may be re-screened once the minimumduration of time since antibiotics use has been met.
- Current and regular use of a probiotic and or prebiotic supplement within the past 2weeks. Of note, patients taking prebiotic or probiotic supplements may be re-screened.
- Documented inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) orceliac disease
Study Design
Total Participants: 68
Study Start date:
February 21, 2022
Estimated Completion Date:
January 31, 2025
Study Description
Connect with a study center
Sheppard Pratt Health System
Baltimore, Maryland 21285
United StatesActive - Recruiting
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