Last updated: October 16, 2023
Sponsor: Centre for Addiction and Mental Health
Overall Status: Completed
Phase
N/A
Condition
Tourette's Syndrome
Schizophrenia And Schizoaffective Disorders
Mood Disorders
Treatment
Repetitive Transcranial Magnetic Stimulation (Intermittent Theta Burst Stimulation)
Repetitive Transcranial Magnetic Stimulation (Sham)
Repetitive Transcranial Magnetic Stimulation
Clinical Study ID
NCT04418011
133/2019
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18-55 years;
- Male or Female;
- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or schizophreniformdisorder; other specified psychotic disorder (documented by SCID-5);
- Prescription of antipsychotic medication for at least 60 days and constant dose for 30days prior to study entry (either first or second generation antipsychoticspermitted);
- Able to participate in the informed consent process and provide voluntary informedconsent.
Exclusion
Exclusion Criteria:
- DSM-5 substance use disorder (other than caffeine, mild cannabis use, or tobacco)within the past six months; or a positive baseline urine drug screen (except cannabisfor mild use). Only participants meeting a moderate to severe cannabis use disorderwill be excluded
- Type 1 diabetes mellitus (i.e., insulin-dependent diabetes mellitus with onset < 35years of age and/or diabetes mellitus that has been complicated by a prior documentedepisode of ketoacidosis)
- Acute or unstable medical illness (e.g. delirium, cancer, uncontrolled diabetes,decompensated cardiac, hepatic, renal or pulmonary disease, stroke, or myocardialinfarction), whose pathology or treatment could alter the presentation or treatment ofschizophrenia or significantly increase the risk associated with the proposedtreatment protocol
- Neurological disease associated with extrapyramidal signs and symptoms (e.g.Parkinson's disease); epilepsy (i.e. seizures not due to medication/drugs or due tofever) or physical signs of stroke; any diagnosis of a Central Nervous System (CNS)disorder
- Requires a benzodiazepine with a regular dose equivalent to lorazepam 2 mg/day orhigher or any anticonvulsant due to the potential of these medications to limit theefficacy of rTMS
- Suspected DSM-5 intellectual disability based upon clinical interview and psychosocialhistory or estimated IQ of <71
- Prior Psychosurgery
- Presence of MRI contraindications (e.g. pacemakers)
- Pregnancy (self-report)
- rTMS treatment in the last 5 years
- Non-English speakers
Study Design
Total Participants: 70
Treatment Group(s): 3
Primary Treatment: Repetitive Transcranial Magnetic Stimulation (Intermittent Theta Burst Stimulation)
Phase:
Study Start date:
November 30, 2020
Estimated Completion Date:
February 02, 2023
Study Description
Connect with a study center
Centre for Addiction and Mental Health
Toronto, Ontario
CanadaSite Not Available
Maryland Psychiatric Research Centre
Catonsville, Maryland 21228
United StatesSite Not Available
The Feinstein Institute for Medical Research
Manhasset, New York 11030
United StatesSite Not Available

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