Negative Symptoms With Primary Psychotic DisorderSchizophrenia
Investigational drug(s) / intervention(s)
high-frequency rTMSTBSplacebo
high-frequency rTMS: repetitive transcranial magnetic stimulation
TBS: theta burst stimulation
placebo: placebo transcranial magnetic stimulation
Study summary
Treatment of depression with repetitive transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. The treatment of negative symptoms with the same protocol in schizophrenia is considered as possible effective. Theta burst stimulation is a new protocol which is characterized by shorter sessions showing first evidence that it's efficacy is comparable to the high-frequency rTMS. In this randomized placebo-controlled study the efficacy of high-frequency rTMS and TBS are evaluated.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* ICD-10: schizophrenia with primarily negative symptoms
* Age: 18-75 years
* at least 35 Points at the composite score of the SANS
* stabe medication during the last 2 weeks (at the investigator's discretion)
* written informed consent (by the patient or guardian)
Exclusion Criteria:
* clinically relevant unstable concomitant somatic diseases
* previous treatment by rTMS
* conditions in which TMS may not be applicated, as e.g., cardiac pacemakers or ferromagnetic implants
* history of epileptic seizures
* current substance or alcohol abuse, or clinically relevant comorbidity (according to M.I.N.I. interview)
* unacceptable concomitant medication (benzodiazepines in higher doses, e.g., Lorazepam \> 2 mg/d, Diazepam \> 10 mg/d)
* insufficient knowledge of the language of the country of the treatment site
* pregnancy and nursing period
* current statutory hospitalisation
Primary outcome measure(s)
Scale for the Assessement of Negative Symptoms (SANS) — 4 weeks negative symptoms in schizophrenia with 25 items and a range 0-125 with higher score representing more symptoms
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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