Validation of a Single-Subject Treatment Outcome Predictor for Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Negative Symptoms in Schizophrenia

Not Applicable

Recruiting

Conditions: DSM-5: Schizophrenia spectrum and other psychotic disorders
F20
Schizophrenia

Registration Number: DRKS00022214

Lead Sponsor: Klinikum der Universität München, Campus Großhadern

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 76

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

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)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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