DSM-5: Schizophrenia spectrum and other psychotic disorders F20
Conditions
Interventions
Group 1: The participants first go through study phase 1, i.e. 3 weeks of treatment with rTMS. For responders a 12 week follow-up follows. For non-responders, study phase 2 follows, i.e. 3 weeks of tr
Sponsors
Klinikum der Universität München, Campus Großhadern
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Diagnostic criteria for schizophrenia spectrum and other psychotic disorders according to DSM-5 assessed by the MINI (“Delusional disorder”, “Brief psychotic disorder”, “Schizophreniform disorder”, “Schizophrenia”, “Schizoaffective disorder”, “Other specified schizophrenia spectrum and other psychotic disorder”, “Unspecified schizophrenia spectrum and other psychotic disorder”); PANSS negative sum score >20 points, 1 of items N1–N7 =4; stable antipsychotic medication for a week before baseline; signed informed consent “Einwilligung in die Teilnahme an der klinischen Studie”
Exclusion criteria
Exclusion criteria: Patient who is not suitable for the study in the opinion of the investigator; involuntary stay in hospital at the time of recruitment; clinically relevant instable medical comorbidity or condition; insufficient cognitive abilities measured by verbal IQ < 85 assessed by the WST; moderate or severe substance use disorder according to the DSM-5 criteria; factors not compatible with the use of rTMS or MRI, e.g. cardiac pace makers or other metallic implants; history of epileptic seizures; insufficient German language ability; pregnancy (women of childbearing potential must have a negative pregnancy test)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of responder rate between the group with predicted good outcome versus the group with predicted bad outcome defined as improvement of =20% Positive and Negative Syndrome Scale (PANSS) negative score immediately after finishing intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Study Phase 1: To evaluate the efficacy of rTMS in improving Positive and Negative Syndrome Scale (PANSS) negative score, PANSS positive score, PANSS general psychopathology score, Wortschatztest (WST) score (German vocabulary test), Category Fluency Test (CFT) score, Thought and Language Index (TLI) score, d2 score, Trail Making Test Part A and B (TMT-AB) score, Digit Symbol Substition Test (DSST) score, Calgary Depression Rating Scale for Schizophrenia (CDSS) score, Occupational Functioning Assessment Scale (SOFAS) score, Global Assessment of Functioning (GAF) score; Study Phase 2: To evaluate whether an extension with iTBS is superior to an extension of rTMS in initial non-responders in improving PANSS negative score, PANSS positive score, PANSS general psychopathology score, WST score, CFT score, TLI score, d2 score, TMT-AB score, DSST score, CDSS score, SOFAS score, GAF score | — |
Countries
Germany
Contacts
Public ContactMarco Schneider
Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität München (LMU)
Outcome results
None listed