Status:
ACTIVE_NOT_RECRUITING
rTMS Add on Value for Amelioration of Negative Symptoms of Schizophrenia
Lead Sponsor:
University of Regensburg
Collaborating Sponsors:
University Hospital, Aachen
University Hospital Ostrava
Conditions:
Negative Symptoms With Primary Psychotic Disorder
Schizophrenia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
Detailed Description
In this randomized placebo-controlled study the efficacy of high-frequency rTMS and TBS are evaluated. The active study arms are high-frequency rTMS and iTBS of the left dorsolateral prefrontal cortex...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04318977
Start Date
February 1 2020
End Date
December 30 2025
Last Update
September 19 2025
Active Locations (4)
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1
Brno University Hospital
Brno, Czechia
2
University Hospital Ostrava
Ostrava, Czechia
3
University Hospital Aachen
Aachen, Germany
4
University of Regensburg
Regensburg, Germany