Status:
COMPLETED
Neuromodulation of Social Cognitive Circuitry in People With Schizophrenia Spectrum Disorders
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
Northwell Health
University of Maryland, Baltimore
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
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...
Detailed Description
This study is a randomized, double blind, sham controlled study which aims to use repetitive transcranial magnetic stimulation (rTMS), a form of neuromodulation, to target the neural circuitry of soci...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04418011
Start Date
November 30 2020
End Date
February 2 2023
Last Update
October 17 2023
Active Locations (3)
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1
Maryland Psychiatric Research Centre
Catonsville, Maryland, United States, 21228
2
The Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
3
Centre for Addiction and Mental Health
Toronto, Ontario, Canada