Gut Microbiome in AP Naive

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-07

Study Completion Date

2022-03-31

Brief Summary

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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.

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Detailed Description

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The objectives of the study are to examine the gut microbiome composition and diversity in patients with schizophrenia, schizoaffective disorder, or other specified schizophrenia spectrum and other psychotic disorder at 6 weeks and 3 months post antipsychotic initiation. Furthermore, the team aims to investigate causality of antipsychotic (AP)-induced changes in the GMB in relation to metabolic changes. This will be accomplished by transplanting human gut microbiota from patients initiating an AP treatment into germ-free mice (independent animal protocol). The final objective is to observe changes in cognition associated with changes in metabolic factors and gut microbiome.

The hypotheses of the study are twofold: the primary hypothesis is that there will be changes in the gut microbiome overtime with treatment correlated with metabolic measures (i.e. weight, insulin sensitivity, glucose tolerance, lipids) due to treatment in antipsychotic naïve patients, and the gut microbiome of treated patients transplanted into germ-free mice will induce similar metabolic proving causality (separate animal protocol). The secondary hypothesis is that APs will produce changes psychopathology and cognitive outcome measures which will correlate with changes in gutmicrobiome.

Participants will include individuals who are either antipsychotic naïve or have not taken antipsychotics for at least 3 months prior to study participation. Participants will be between 12 and 35 years of age with a diagnosis of schizophrenia, schizoaffective disorder, or other specified schizophrenia spectrum and other psychotic disorder, as per DSM-V criteria. Participants will be enrolled to reach n=25 complete data sets. Participants who drop out or who are withdrawn will be replaced.

Following provision of written informed consent, participants will be assessed for suitability for inclusion in the study based on the inclusion and exclusion criteria. Participants will be seen across 5 timepoints, including a screening and baseline visit, as well as 3 follow-up appointments.

Within-group analyses will be conducted to evaluate changes in participants at different time points on measures including anthropometric measures, clinical scales, and fasting bloodwork results. Microbiome analysis will include α-diversity metrics for each sample and β-diversity measures (weighted and unweighted unifrac, Specifically we will analyze changes in the microbiome pre- and post- antipsychotic treatment and whether changes in the microbiome associate with other clinical and biochemical measures. We will also determine whether patients that develop metabolic side effects with antipsychotic treatment have different microbial profiles than those who do not develop these side effects.

Whole body insulin sensitivity is calculated based on the original description by Matsuda at baseline and endpoint. HOMA-IR will be calculated at baseline, week 6, and week 12 to determine change in insulin resistance over time.

A blood sample will be collected for DNA extraction to examine for the genes that that are hypothesized to be associated to response or side effects following antipsychotic medication. Fecal DNA analyses will be completed at McMaster University. Stool samples will be collected from participants at baseline, weeks 3 and 6. Participants will be given stool collection kits (OMNIgene•GUT, DNA Genotek Ottawa, ON). Participants will return the sample at their earliest convenience. Once returned, samples will be immediately frozen and stored at -80°C.

Conditions

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Psychotic Disorder Schizophrenia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational - Case Arm

All participants will be placed in this arm or group if they have an eligible psychiatric diagnosis as a case (there is no randomization procedure)

Observation

Intervention Type OTHER

No intervention administered.

Observational - Healthy Control Arm

All participants will be placed in this arm if they are healthy controls (there is no randomization procedure)

Observation

Intervention Type OTHER

No intervention administered.

Interventions

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Observation

No intervention administered.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Previous antipsychotic treatment (greater than two weeks within the preceding 3 months)
* Presence of DSM-5 diagnosis which is not schizophrenia, schizoaffective disorder, or other specified schizophrenia spectrum and other psychotic disorder
* Use of any other medications for treatment of lipids, glucose, or weight as deemed to be clinically significant by the PI
* Use of other medications where the dose has changed within the past 6 weeks which are deemed by the PI to be clinically significant
* Pregnancy
* Eating disorder - active or previous
* Major medical or surgical event within the preceding 3 months
* Acute suicidal risk
* Irritable bowel disease, Crohn's disease, and/or diverticulitis/diverticulosis
* Type I diabetes, kidney/liver disease, and/or cancer
* 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
* Antibiotic/probiotic use within past 4 weeks
* Any other medical conditions or lifestyle habits deemed by the PI to impact the integrity of the sample/microbiota

Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No