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Observational - Healthy Control Arm for Psychosis

N/A
Waitlist Available
Led By Margaret K Hahn, PhD, MD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks (baseline, week 6, week 12)
Awards & highlights

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. 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.

Eligible Conditions
  • Psychosis
  • Schizophrenia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks (baseline, week 6, week 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks (baseline, week 6, week 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Gut microbiome and DNA
Secondary study objectives
Abnormal Involuntary Movement Scale (AIMS)
Albumin
BMI
+35 more

Side effects data

From 2016 Phase 3 trial • 356 Patients • NCT00048997
31%
Fatigue (lethargy, malaise, asthenia)
23%
Alopecia
17%
Late RT Toxicity: Other: NOS
11%
Nausea
10%
Anorexia
9%
Late RT Toxicity: Brain: NOS
9%
Headache
7%
Late RT Toxicity: Skin: NOS
6%
Memory loss
1%
Dyspnea (shortness of breath)
1%
Hemorrhage-Other
1%
Ataxia (incoordination)
1%
Mood alteration-depression
1%
Pain-Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prophylactic Cranial Irradiation (PCI)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Observational - Healthy Control ArmExperimental Treatment1 Intervention
All participants will be placed in this arm if they are healthy controls (there is no randomization procedure)
Group II: Observational - Case ArmExperimental Treatment1 Intervention
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)

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
366 Previous Clinical Trials
82,311 Total Patients Enrolled
16 Trials studying Psychosis
1,914 Patients Enrolled for Psychosis
McMaster UniversityOTHER
906 Previous Clinical Trials
2,613,216 Total Patients Enrolled
Margaret K Hahn, PhD, MDPrincipal InvestigatorCentre for Addiction and Mental Health
1 Previous Clinical Trials
64 Total Patients Enrolled
~3 spots leftby Sep 2025