NCT03414151Active, not recruiting
Gut Microbiome in AP Naive
Gut Microbiome and Metabolic Dysfunction in Antipsychotic Naïve Patients
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
Antipsychotic (AP) medications are currently the cornerstone of treatment for schizophrenia (SCZ), with off-label prescription rapidly increasing in youth, with an established two-fold increase in standardized mortality ratio attributable to cardiovascular disease in this population. However, APs have been associated with common and serious metabolic adverse effects including weight gain and diabetes, to which youth are disproportionally vulnerable. The Gut Microbiome (GMB) has been suggested as a potential target warranting further study as a mechanism of AP induced weight gain and has also been linked directly with cognition and behavior. It is hypothesized that there will be changes in the gut microbiome overtime with treatment correlated with metabolic measures and that APs will produce changes in glucose tolerance, insulin sensitivity, adipokines, glucagon like peptide (GLP)-1, lipids, fasting glucose, body weight, and cognition.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 25 (estimated)
- First submitted
- 28 Oct 2017
- Start date
- 7 Feb 2018
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Schizophrenia
- NCT number
- NCT03414151
What you commit to
- Study type: Observational
- Planned participants: 25
- From 7 Feb 2018 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous antipsychotic treatment (greater than two weeks within the preceding 3 months)
- Use of other medications where the dose has changed within the past 6 weeks which are deemed by the PI to be clinically significant
- Eating disorder - active or previous
- Major medical or surgical event within the preceding 3 months
- Organ transplant
- Moderate to severe alcohol use , use of street drugs, and/or cannabis use (as deemed by PI)
- Immunosuppressants and/or anti-inflammatory medications
Other illness
- Presence of DSM-5 diagnosis which is not schizophrenia, schizoaffective disorder, or other specified schizophrenia spectrum and other psychotic disorder
- Irritable bowel disease, Crohn's disease, and/or diverticulitis/diverticulosis
- Type I diabetes, kidney/liver disease, and/or cancer
- Any other medical conditions or lifestyle habits deemed by the PI to impact the integrity of the sample/microbiota
Lab values
- Use of any other medications for treatment of lipids, glucose, or weight as deemed to be clinically significant by the PI
Other
- Pregnancy
- Acute suicidal risk
- Antibiotic/probiotic use within past 4 weeks
Who the study is looking for
- Ages 12-35
- Antipsychotic naïve or antipsychotic treatment for equal to or less than 2 weeks within the past 3 months; the minimum AP dose will be left to the discretion of the PI
- DSM-5 diagnosis (using SCID-IV-TR with supplemental questions from SCID-5 or SCID-5) of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, and brief psychotic disorder, psychotic disorder NOS. and/or antipsychotic treatment for schizophrenia, schizoaffective disorder, or other specified schizophrenia spectrum and other psychotic disorder.
Age in the registry: 12 years to 35 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Addiction and Mental Health Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.