Schizophrenia Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 01/06/2026:
Patients diagnosed with schizophrenia will be included in the study. Patients will be randomly allocated according to permuted block design to one of two inte
Sponsors
National Institute of Mental Health
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female outpatients at ages 18-70 years old 2. Meet DSM-V criteria for schizophrenia as determined by Structured Clinical Interview for DSM-V (SCID-5) 3. The mental ability to understand and sign the Informed Consent Form 4. Being on a stable and adequate dose of antipsychotics and/or antidepressants (monotherapy or combination) for at least four weeks before enrollment
Exclusion criteria
Exclusion criteria: 1. Psychiatric comorbidity on axes I and II according to DSM-V six months before enrollment to the study except for SCH-related disorders 2. Personality disorder that makes participation in the trial difficult 3. Substance dependence except for nicotine 4. Substantial suicidal risk as judged by the treating psychiatrist 5. Sensory and motor disabilities precluding participation in computer-based tests 6. Electronic or metal implants in the head
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 07/05/2025: Attention domain and Total score in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score at baseline (V0) and week two (V1) Previous primary outcome measure: Delayed memory Index measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score at baseline (V0) and week two (V1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 01/06/2026: 1. Changes in cognition, measured using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subdomains score (Immediate memory, Delayed memory, Visuospatial abilities, Language and Attention), Trail Making Test – TMT score, Sternberg Memory Test score, Wisconsin Card Sorting Test – WCST score at baseline (V0), week two (V1), and week six (V2) 2. Changes in speech abilities, measured using reading of text, free speech production, reproduction of emotional and neutral speech, and picture description at baseline (V0), week two (V1), and week six (V2) 3. Symptom severity, measured using the Positive and Negative Syndrome Scale (PANSS) at baseline (V0), week two (V1), and week six (V2) 4. Neurophysiological changes, measured using EEG (power measurements and selected connectivity parameters) and TMS signal change at baseline (V0), week two (V1), and week six (V2) 5. Cognition changes in the RBANS Attention domain and Total score at baseline (V0) and week six (V2) _____ Previous secondary outcome measure as of 07/05/2025: 1. Changes in cognition, measured using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subdomains score (Immediate memory, Delayed memory, Visuospatial abilities, Language and Attention), Trail Making Test – TMT score, Sternberg Memory Test score, Wisconsin Card Sorting Test – WCST score at baseline (V0), week two (V1), and week six (V2) 2. Changes in speech abilities, measured using reading of text, free speech production, reproduction of emotional and neutral speech, and picture description at baseline (V0), week two (V1), and week six (V2) 3. Symptom severity, measured using the Positive and Negative Syndrome Scale (PANSS) at baseline (V0), week two (V1), and week six (V2) 4. Neurophysiological changes, measured using EEG and TMS signal change at baseline (V0), week two (V1), and week six (V2) 5. Cognition changes in the RBANS Attention domain an | — |
Countries
Czech Republic
Contacts
Public ContactMonika Klírová
Outcome results
None listed