Neuromodulation of Social Cognitive Circuitry in People With Schizophrenia Spectrum Disorders
Completed · Not applicable · Has a placebo group
Conditions studied: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
In brief
In this study, the investigators will be examining the effects of repetitive transcranial magnetic stimulation (rTMS) and intermittent theta burst stimulation (iTBS) on social cognitive impairments in individuals with schizophrenia spectrum disorders. Participants will be chosen by chance to receive either active rTMS stimulation, active iTBS stimulation, sham rTMS, or sham iTBS. The investigators predict that active 10Hz and iTBS stimulation will improve social cognitive impairments compared to sham stimulation. We aim to identify which type of active stimulation is most effective at inducing changes social cognition brain circuitry and secondarily which type of active stimulation is best tolerated and most effective at inducing changes in social cognitive performance.
Key facts
- Study ID
- NCT04418011
- Run by
- Centre for Addiction and Mental Health
- People needed
- 70
- Starts
- 2020-11-30
- Expected to finish
- 2023-02-02
- Last updated by the study team
- 2023-10-17
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-55 years;
- Male or Female;
- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder; other specified psychotic disorder (documented by SCID-5);
- Prescription of antipsychotic medication for at least 60 days and constant dose for 30 days prior to study entry (either first or second generation antipsychotics permitted);
- Able to participate in the informed consent process and provide voluntary informed consent.
You may not qualify if…
- 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 cannabis for mild use). Only participants meeting a moderate to severe cannabis use disorder will be excluded
- Type 1 diabetes mellitus (i.e., insulin-dependent diabetes mellitus with onset < 35 years of age and/or diabetes mellitus that has been complicated by a prior documented episode of ketoacidosis)
- Acute or unstable medical illness (e.g. delirium, cancer, uncontrolled diabetes, decompensated cardiac, hepatic, renal or pulmonary disease, stroke, or myocardial infarction), whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment 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 to fever) 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 or higher or any anticonvulsant due to the potential of these medications to limit the efficacy of rTMS
- Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history 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
Where it is running
- Maryland Psychiatric Research Centre — Catonsville, Maryland, United States
- The Feinstein Institute for Medical Research — Manhasset, New York, United States
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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