rTMS Add on Value for Amelioration of Negative Symptoms of Schizophrenia

NCT04318977 | Active Not Recruiting

• 1 other identifier: 19-1616-101
• Study Type: interventional
• Target: 62
• Locations: 2 countries
• Sites: 4

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 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.

Conditions

Negative Symptoms With Primary Psychotic Disorder; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Scale for the Assessement of Negative Symptoms (SANS)

  negative symptoms in schizophrenia with 25 items and a range 0-125 with higher score representing more symptoms

  4 weeks

Secondary Outcomes (11)

• Scale for the Assessement of Negative Symptoms (SANS)

  2 weeks, 4 weeks, 12 weeks

• Positive and Negative syndrome scale (PANSS)

  2 weeks, 4 weeks, 12 weeks

• Calgary Depression Scale for Schizophrenia (CDSS)

  2 weeks, 4 weeks, 12 weeks

• Clinical global impression (CGI)

  2 weeks, 4 weeks, 12 weeks

• Major Depression Inventory (MDI)

  2 weeks, 4 weeks, 12 weeks

Study Arms (3)

high-frequency repetitive transcranial magnetic stimulation

EXPERIMENTAL

repetitive transcranial magnetic stimulation over left dorsolateral prefrontal cortex using 3000 pulses applied with 10Hz and 120% resting motor threshold

Device: high-frequency rTMS

theta burst stimulation

EXPERIMENTAL

intermittent theta burst stimulation over left dorsolateral prefrontal cortex using 600 pulses applied in trains of 10 triplets/bursts (50Hz) with 8s intertrain-interval and 120% resting motor threshold

Device: TBS

sham rTMS

PLACEBO COMPARATOR

half of the patients with high-frequency repetitive transcranial magnetic stimulation and half of the patients with theta burst Stimulation with angled coil (45 degree) or sham coil

Device: placebo

Interventions

high-frequency rTMS DEVICE

repetitive transcranial magnetic stimulation

high-frequency repetitive transcranial magnetic stimulation

TBS DEVICE

theta burst stimulation

theta burst stimulation

placebo DEVICE

placebo transcranial magnetic stimulation

sham rTMS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regensburg: lead
• University Hospital, Aachen: collaborator
• University Hospital Ostrava: collaborator
• Brno University Hospital: collaborator

Study Sites (4)

Brno University Hospital

Brno, Czechia

Location

University Hospital Ostrava

Ostrava, Czechia

Location

University Hospital Aachen

Aachen, Germany

Location

University of Regensburg

Regensburg, Germany

Location

Related Publications (1)

• Hebel T, Langguth B, Schecklmann M, Schoisswohl S, Staudinger S, Schiller A, Ustohal L, Sverak T, Horky M, Kasparek T, Skront T, Hyza M, Poeppl TB, Riester ML, Schwemmer L, Zimmermann S, Sakreida K. Rationale and study design of a trial to assess rTMS add-on value for the amelioration of negative symptoms of schizophrenia (RADOVAN). Contemp Clin Trials Commun. 2022 Jan 20;26:100891. doi: 10.1016/j.conctc.2022.100891. eCollection 2022 Apr.

  PMID: 35128142 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Berthold Langguth, MD, PhD

  University of Regensburg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: randomized controlled trial with two active and one placebo arm

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 24, 2020
• Study Start: February 1, 2020
• Primary Completion: August 14, 2024
• Study Completion: December 30, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2); DE (2)