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Schizophrenia/Schizoaffective Disorder for Schizophrenia

N/A
Recruiting
Led By Philip Gerretsen, MD, PhD
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pet scans will be timed to coincide to the two time-points, before and after 2-weeks of tdcs treatment that is completed under the parent study protocol (reb #103-2018)
Awards & highlights

Summary

This study will examine changes in synaptic density with transcranial direct current stimulation (tDCS) in the brains of patients with schizophrenia. Synaptic density levels will be measured using a novel positron emission tomography (PET) radiotracer \[18F\]SDM-8, which is currently the best-in-class method to quantify synaptic density in humans. This will be a companion study to a parent study by our group examining the effects of tDCS on treatment adherence in schizophrenia (REB #103-2018).

Eligible Conditions
  • Schizophrenia
  • Schizoaffective Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pet scans will be timed to coincide to the two time-points, before and after 2-weeks of tdcs treatment that is completed under the parent study protocol (reb #103-2018)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pet scans will be timed to coincide to the two time-points, before and after 2-weeks of tdcs treatment that is completed under the parent study protocol (reb #103-2018) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Synaptic density changes

Side effects data

From 2018 Phase 3 trial • 156 Patients • NCT02516046
2%
agitation
1%
headache
1%
dizziness postural
1%
acute kidney injury
1%
malignant neoplasm
1%
myocardial infarction
1%
vertigo
1%
diarrhoea
1%
nausea
1%
injection site bruising
1%
fall
1%
procedural vomiting
1%
hypomagnesaemia
1%
myopathy
1%
hypoxic-ischaemic encephalopathy
1%
tremor
1%
mental disorder
1%
restlessness
1%
Cardiac failure congestive
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety Analysis Population

Trial Design

1Treatment groups
Experimental Treatment
Group I: Schizophrenia/Schizoaffective DisorderExperimental Treatment1 Intervention
Participants with Schizophrenia/Schizoaffective Disorder and currently enrolled in the tDCS-adherence parent study (REB# 103-2018).

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
366 Previous Clinical Trials
82,316 Total Patients Enrolled
58 Trials studying Schizophrenia
4,211 Patients Enrolled for Schizophrenia
Philip Gerretsen, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
5 Previous Clinical Trials
274 Total Patients Enrolled
4 Trials studying Schizophrenia
214 Patients Enrolled for Schizophrenia
~5 spots leftby Sep 2025
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