Psychotic DisorderNCT03414151
Gut Microbiome in AP Naive
An observational study of Psychotic Disorder and Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Psychotic Disorder, Schizophrenia
- What is being tested?
- Observation
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 7 Feb 2018to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- All sexes
- Child, Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gut Microbiome and Metabolic Dysfunction in Antipsychotic Naïve Patients
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.
Read the detailed description
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
- Psychotic Disorder, Schizophrenia
- Being tested
- Observation
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
No intervention administered.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Observation | |
| Observational - Healthy Control Arm | All participants will be placed in this arm if they are healthy controls (there is no randomization procedure) Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gut microbiome and DNA
Patients will collect fecal samples at home using our well-established protocol at baseline, 6 weeks, and 12 weeks. Participants will be provided a kit containing a sterile specimen container and a cooling pad, as well as a stool collection tube for DNA analyses (OMNIgene•GUT, DNA Genotek Ottawa, ON). Patients will be instructed to transfer several grams of the feces into the specimen container and place the sample in the 2 bioharzard bags and then store in the freezer. On the day of their appointment they will transport the sample on the cooling pad (previously placed in the freezer) to their appointment. When the patient delivers the sample to the research staff, it will be immediately placed in a -80ºC freezer prior to being analyzed. These analyses with fecal samples will be conducted at McMaster University at the Farncombe Family Institute.
Measured: 12 weeks (baseline, week 6, week 12)
Secondary outcomes (38)
Oral glucose tolerance test
Following collection of baseline samples, a standard glucose drink (75mg) is given orally, and a blood sample of insulin and glucose is obtained exactly 1 hour and 2 hours after the standard glucose drink is administered. Blood will be drawn at a total of 4 time points. Serums which will be collected during this procedure include fasting glucose; fasting insulin; leptin, fasting free fatty-acids, c-peptide, cortisol; Glucagon-like polypeptide-1 (GLP-1), glucagon inhibitory peptide (GIP),cytokines, ghrelin related to weight gain and glucose metabolism.
Measured: 12 weeks (baseline and week 12)
Height
Height (cm) will be collected at the initial study visit
Measured: 12 weeks
Weight
Weight (kg) will be collected at each study visit
Measured: 12 weeks
Blood pressure
Blood pressure will be measured at each study visit (sys/dia)
Measured: 12 weeks
Heart Rate
Heart rate will be measured at each study visit (BPM)
Measured: 12 weeks
Waist Circumference
Waist circumference (cm) will be measured at each study visit
Measured: 12 weeks
BMI
BMI (kg/m^2) will be calculated at each study visit
Measured: 12 weeks
Prolactin
Prolactin levels will be collected via blood work.
Measured: 12 weeks (baseline, week 6, week 12)
Liver enzymes
Liver enzymes including ALT (unit/L), ALP (unit/L), and AST (unit/L) will be collected via bloodwork.
Measured: 12 weeks (baseline, week 6, week 12)
Bilirubin
Bilirubin (mcmol/L) values will be collected via bloodwork.
Measured: 12 weeks (baseline, week 6, week 12)
GGT
GGT (unit/L) values will be collected via bloodwork.
Measured: 12 weeks (baseline, week 6, week 12)
Albumin
Albumin (g/L) values will be collected via bloodwork.
Measured: 12 weeks (baseline, week 6, week 12)
HbA1c
HbA1c will be collected via bloodwork.
Measured: 12 weeks (baseline, week 6, week 12)
Fasting blood work
Fasting bloodwork values including lipids (mmol/L), glucose (mmol/L), AAP serum levels (mmol/L), and electrolytes (mmol/L) will be collected via bloodwork.
Measured: 12 weeks (baseline, week 6, week 12)
CBC
CBC values will be collected via blood work.
Measured: 12 weeks (baseline, week 6, week 12)
Thyroid Stimulating Hormone (TSH)
TSH (mIU/L) values will be collected via blood work.
Measured: 12 weeks (baseline, week 6, week 12)
Insulin
Insulin (pmol/L) values will be collected via blood work.
Measured: 12 weeks (baseline, week 6, week 12)
Leptin
Leptin values will be collected via blood work.
Measured: 12 weeks (baseline, week 6, week 12)
Free Fatty Acids (FFA)
FFA values will be collected via blood work.
Measured: 12 weeks (baseline, week 6, week 12)
C-peptide
C-peptide (ng/mL) values will be collected via blood work.
Measured: 12 weeks (baseline, week 6, week 12)
Cortisol
Cortisol (mcg/dL) values will be collected via blood work.
Measured: 12 weeks (baseline, week 6, week 12)
DNA
DNA will be collected via blood work.
Measured: Baseline measure
Brief Psychiatric Rating Scale 18 item (BPRS)
The BPRS is a rater administered interview evaluating psychiatric symptoms. Total scores range between 18 and 126, with higher scores indicating greater severity of symptoms. Total scores are calculated by adding all individual item scores.
Measured: 12 weeks (baseline, week 6, week 12)
The Positive and Negative Symptom Questionnaire (SANS)
The SANS is a rater administered interview evaluating positive and negative symptoms in psychosis. Total scores range from 0 to 110, with higher scores indicating greater severity of symptoms.Total scores are calculated by adding all individual item scores.
Measured: 12 weeks (baseline, week 6, week 12)
Clinical Global Impression (CGI)
The CGI is a rater-observed measure which evaluates overall mental illness severity. The score ranges from 1 to 7, with a higher score indicating greater severity of symptoms.
Measured: 12 weeks (baseline, week 6, week 12)
The Calgary Depression Scale for Schizophrenia (CDSS)
The CDSS is a rater administered interview evaluating the presence and severity of depressive symptoms in schizophrenia. The total score ranges from 0 to 27, with higher scores indicating a greater severity. Total scores are calculated by adding all individual item scores.
Measured: 12 weeks (baseline, week 6, week 12)
Quality of Life Scale (QLS)
The QLS is a questionnaire measuring the functioning of outpatient schizophrenia patients and measures the quality of relationships, occupational roles, and personal experiences. Subscale scores include Interpersonal Relations (range 0-72), Instrumental Role (range 0-36), Intrapsychic Function (range 0-63), Common Objects and Activities (range 0-18). The total score is then calculated by adding all the individual items together for a total score range of between 0-189. Higher scores across all variables indicate poorer quality of life. Total scores are calculated by adding all individual item scores.
Measured: 12 weeks (baseline, week 6, week 12)
Birchwood Social Functioning Scale (BSFS)
The BSFS is a scale used to measure quality of social functioning. Subscales include Social Engagement/Withdrawal (range 0-15), Interpersonal Communication (range 0-9), Independence-Performance (range 0-39), Recreation (range 0-45), Prosocial (range 0-66), Independence-Competence (range 0-39), and Occupation/Employment (range 0-10). Higher scores indicate better social functioning. Scores are calculated by adding all individual item scores.
Measured: 12 weeks (baseline, week 6, week 12)
UKU Side Effects Scale
A rater-administered evaluation of side-effects related to psychopharmacological drugs. Ratings are given on a scale of 0-3, with higher scores indicating greater severity. An overall score, assigned by rater impression, is given to indicate overall incapacity due to side-effects.
Measured: 12 weeks (all time points)
Abnormal Involuntary Movement Scale (AIMS)
A rater-administered evaluation of tardive dyskinesia. Scores are assigned across 3 categories including facial and oral movement, extremity movement, and trunk movement. There are no subscale scores however a global rating is given from a range of 0-4 based on the average of the categorical ratings, with higher scores indicated greater severity.
Measured: 12 weeks (baseline, week 12)
Barnes Akathisia Scale (BAS)
A rater-administered evaluation of akathisia. A rating of 0-3 is given for objective and subjective awareness of fidgeting, respectively, as well as for distress related to movement. A global score, as calculated on the average of all individual scores, is assigned on a scale of 0-5.
Measured: 12 weeks (baseline, week 12)
Simpson Angus Scale (SAS)
A rater-administered evaluation of extrapyramidal symptoms. Scores range from normal (score 0-3), minimal degree of movement disorder (score 3-5), clinically significant degree of movement disorder (score 6-11), and severe degree of movement disorder (score 12-17). Items are rated individually (i.e. no composite score).
Measured: 12 weeks (baseline, week 12)
Food Cravings Questionnaire (FCQ)
A self-administered rating of food cravings and eating behaviours, both trait and state. A total score is calculated by adding all scores together. Higher scores indicate heightened trait and or state behaviour.
Measured: 12 weeks (baseline, week 6, week 12)
Visual Analog Scale (VAS)
A self-administered rating of food cravings where participants mark on a continuum . The location of the mark is then measured (cm) for each item. Some items are reverse scored so individual items need to be reviewed for context. Only individual item scores are assigned (i.e. no total score assigned).
Measured: 12 weeks (baseline, week 6, week 12)
Harvard Youth/Adolescent Questionnaire (YAQ)
A self-administered food frequency questionnaire designed for older children and adolescents. Individuals scores are evaluated for nutritional breakdown. This is a qualitative self-report assessment.
Measured: 12 weeks (baseline, week 6, week 12)
International Physical Activity Questionnaire (IPAQ)
A rater administered questionnaire evaluating health-related physical activity. A composite score is calculated by combining subscale scores of walking, moderate and vigorous physical activity, and the score is categorized into "low", "medium", or "high" physical activity category.
Measured: 12 weeks (baseline and week 12)
MATRICS Consensus Cognitive Battery
An evaluation of key cognitive domains relevant to individuals with schizophrenia
Measured: 12 weeks (baseline and week 12)
Investigation of Mental Rotation, Allocentricity-Egocentricity, and Perspective Taking (IMAP)
An evaluation of the ability of participants to take perspective from an egocentric or allocentric point of view and to rotate mentally the stimulus or their point of view. Participants are rated on accuracy and reaction time.
Measured: 12 weeks (baseline and week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start7 Feb 2018
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Margaret Hahn, Centre for Addiction and Mental Health
- Investigators
- Margaret K Hahn, PhD, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414151
- Sponsor's protocol ID
- 030/2017
- Status last verified
- May 2026
- First submitted
- 28 Oct 2017
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hennekens CH, Hennekens AR, Hollar D, Casey DE. Schizophrenia and increased risks of cardiovascular disease. Am Heart J. 2005 Dec;150(6):1115-21. doi: 10.1016/j.ahj.2005.02.007.
PubMed 16338246Gold SM, Dziobek I, Sweat V, Tirsi A, Rogers K, Bruehl H, Tsui W, Richardson S, Javier E, Convit A. Hippocampal damage and memory impairments as possible early brain complications of type 2 diabetes. Diabetologia. 2007 Apr;50(4):711-9. doi: 10.1007/s00125-007-0602-7. Epub 2007 Feb 14.
PubMed 17334649Letourneau G, Bentaleb LA, Stip B, Luck D, Stip E. Relationships between Brain Structure and Metabolic Changes in Schizophrenia Patients Treated with Olanzapine: A Voxel-Based Morphometric Study. Schizophr Res Treatment. 2011;2011:862350. doi: 10.1155/2011/862350. Epub 2011 May 25.
PubMed 22937275Bora E, Akdede BB, Alptekin K. The relationship between cognitive impairment in schizophrenia and metabolic syndrome: a systematic review and meta-analysis. Psychol Med. 2017 Apr;47(6):1030-1040. doi: 10.1017/S0033291716003366. Epub 2016 Dec 29.
PubMed 28032535
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiome and Metabolic Dysfunction in Antipsychotic Naïve Patients
- ClinicalTrials.gov ID
- NCT03414151
- Acronym / sponsor ID
- 030/2017
- Conditions
- Psychotic Disorder, Schizophrenia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational - Case Arm | – | Other: ObservationAll participants will be placed in this arm or group if they have an eligible psychiatric diagnosis as a case (there is no randomization procedure) |
| Observational - Healthy Control Arm | – | Other: ObservationAll participants will be placed in this arm if they are healthy controls (there is no randomization procedure) |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationNo intervention administered. | Other | Observational - Case Arm, Observational - Healthy Control Arm |
Primary outcome
Change in Gut microbiome and DNA
Time frame: 12 weeks (baseline, week 6, week 12)
Patients will collect fecal samples at home using our well-established protocol at baseline, 6 weeks, and 12 weeks. Participants will be provided a kit containing a sterile specimen container and a cooling pad, as well as a stool collection tube for DNA analyses (OMNIgene•GUT, DNA Genotek Ottawa, ON). Patients will be instructed to transfer several grams of the feces into the specimen container and place the sample in the 2 bioharzard bags and then store in the freezer. On the day of their appointment they will transport the sample on the cooling pad (previously placed in the freezer) to their appointment. When the patient delivers the sample to the research staff, it will be immediately placed in a -80ºC freezer prior to being analyzed. These analyses with fecal samples will be conducted at McMaster University at the Farncombe Family Institute.
38 secondary outcomes
Oral glucose tolerance test
Time frame: 12 weeks (baseline and week 12)
Height
Time frame: 12 weeks
Weight
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
Heart Rate
Time frame: 12 weeks
Waist Circumference
Time frame: 12 weeks
BMI
Time frame: 12 weeks
Prolactin
Time frame: 12 weeks (baseline, week 6, week 12)
Liver enzymes
Time frame: 12 weeks (baseline, week 6, week 12)
Bilirubin
Time frame: 12 weeks (baseline, week 6, week 12)
GGT
Time frame: 12 weeks (baseline, week 6, week 12)
Albumin
Time frame: 12 weeks (baseline, week 6, week 12)
HbA1c
Time frame: 12 weeks (baseline, week 6, week 12)
Fasting blood work
Time frame: 12 weeks (baseline, week 6, week 12)
CBC
Time frame: 12 weeks (baseline, week 6, week 12)
Thyroid Stimulating Hormone (TSH)
Time frame: 12 weeks (baseline, week 6, week 12)
Insulin
Time frame: 12 weeks (baseline, week 6, week 12)
Leptin
Time frame: 12 weeks (baseline, week 6, week 12)
Free Fatty Acids (FFA)
Time frame: 12 weeks (baseline, week 6, week 12)
C-peptide
Time frame: 12 weeks (baseline, week 6, week 12)
Cortisol
Time frame: 12 weeks (baseline, week 6, week 12)
DNA
Time frame: Baseline measure
Brief Psychiatric Rating Scale 18 item (BPRS)
Time frame: 12 weeks (baseline, week 6, week 12)
The Positive and Negative Symptom Questionnaire (SANS)
Time frame: 12 weeks (baseline, week 6, week 12)
Clinical Global Impression (CGI)
Time frame: 12 weeks (baseline, week 6, week 12)
The Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: 12 weeks (baseline, week 6, week 12)
Quality of Life Scale (QLS)
Time frame: 12 weeks (baseline, week 6, week 12)
Birchwood Social Functioning Scale (BSFS)
Time frame: 12 weeks (baseline, week 6, week 12)
UKU Side Effects Scale
Time frame: 12 weeks (all time points)
Abnormal Involuntary Movement Scale (AIMS)
Time frame: 12 weeks (baseline, week 12)
Barnes Akathisia Scale (BAS)
Time frame: 12 weeks (baseline, week 12)
Simpson Angus Scale (SAS)
Time frame: 12 weeks (baseline, week 12)
Food Cravings Questionnaire (FCQ)
Time frame: 12 weeks (baseline, week 6, week 12)
Visual Analog Scale (VAS)
Time frame: 12 weeks (baseline, week 6, week 12)
Harvard Youth/Adolescent Questionnaire (YAQ)
Time frame: 12 weeks (baseline, week 6, week 12)
International Physical Activity Questionnaire (IPAQ)
Time frame: 12 weeks (baseline and week 12)
MATRICS Consensus Cognitive Battery
Time frame: 12 weeks (baseline and week 12)
Investigation of Mental Rotation, Allocentricity-Egocentricity, and Perspective Taking (IMAP)
Time frame: 12 weeks (baseline and week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 16338246Hennekens CH, Hennekens AR, Hollar D, Casey DE. Schizophrenia and increased risks of cardiovascular disease. Am Heart J. 2005 Dec;150(6):1115-21. doi: 10.1016/j.ahj.2005.02.007.
- Background: PubMed 17334649Gold SM, Dziobek I, Sweat V, Tirsi A, Rogers K, Bruehl H, Tsui W, Richardson S, Javier E, Convit A. Hippocampal damage and memory impairments as possible early brain complications of type 2 diabetes. Diabetologia. 2007 Apr;50(4):711-9. doi: 10.1007/s00125-007-0602-7. Epub 2007 Feb 14.
- Background: PubMed 22937275Letourneau G, Bentaleb LA, Stip B, Luck D, Stip E. Relationships between Brain Structure and Metabolic Changes in Schizophrenia Patients Treated with Olanzapine: A Voxel-Based Morphometric Study. Schizophr Res Treatment. 2011;2011:862350. doi: 10.1155/2011/862350. Epub 2011 May 25.
- Background: PubMed 28032535Bora E, Akdede BB, Alptekin K. The relationship between cognitive impairment in schizophrenia and metabolic syndrome: a systematic review and meta-analysis. Psychol Med. 2017 Apr;47(6):1030-1040. doi: 10.1017/S0033291716003366. Epub 2016 Dec 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret K Hahn, PhD, MD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorder and Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gut microbiome and DNA (time frame: 12 weeks (baseline, week 6, week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03414151, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.