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rTMS Add on Value for Amelioration of Negative Symptoms of Schizophrenia (RADOVAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318977
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : April 15, 2020
Sponsor:
Collaborators:
University Hospital, Aachen
University Hospital Ostrava
Brno University Hospital
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg

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.

Condition or disease Intervention/treatment Phase
Negative Symptoms With Primary Psychotic Disorder Schizophrenia Device: high-frequency rTMS Device: TBS Device: placebo Not Applicable

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 to treat negative symptoms in schizophrenia. The control arm will include the same number of patients as each active arm and includes both sham rTMS and sham iTBS in the same proportion as the active treatments.

Standards of the trial will be harmonized across four clinical centers with the aim to pool data for analysis. Each center is responsible for ethical approval and adherence to good clinical practice by itself (Sponsor).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial with two active and one placebo arm
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: rTMS Add on Value for Amelioration of Negative Symptoms of Schizophrenia
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: high-frequency repetitive transcranial magnetic stimulation
repetitive transcranial magnetic stimulation over left dorsolateral prefrontal cortex using 3000 pulses applied with 10Hz and 120% resting motor threshold
Device: high-frequency rTMS
repetitive transcranial magnetic stimulation

Experimental: theta burst stimulation
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
theta burst stimulation

Placebo Comparator: sham rTMS
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
placebo transcranial magnetic stimulation




Primary Outcome Measures :
  1. Scale for the Assessement of Negative Symptoms (SANS) [ Time Frame: 4 weeks ]
    negative symptoms in schizophrenia with 25 items and a range 0-125 with higher score representing more symptoms


Secondary Outcome Measures :
  1. Scale for the Assessement of Negative Symptoms (SANS) [ Time Frame: 2 weeks, 4 weeks, 12 weeks ]
    negative symptoms in schizophrenia with 25 items and a range 0-125 with higher score representing more symptoms

  2. Positive and Negative syndrome scale (PANSS) [ Time Frame: 2 weeks, 4 weeks, 12 weeks ]
    positive and negative symptoms in schizophrenia with 30 items and a range 30-210 with higher scores representing more symptoms (total score, score for positive, negative symptoms and for general psychopathology)

  3. Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: 2 weeks, 4 weeks, 12 weeks ]
    Calgary Depression Scale for Schizophrenia

  4. Clinical global impression (CGI) [ Time Frame: 2 weeks, 4 weeks, 12 weeks ]
    measure of overall symptom severity and treatment response on a scale 1-7 with higher scores presenting more symptoms

  5. Major Depression Inventory (MDI) [ Time Frame: 2 weeks, 4 weeks, 12 weeks ]
    measurment of depressivity: 10 items with a range 0-50 and higher values indicating higher scores

  6. Hamilton depression rating scale (HDRS) [ Time Frame: 2 weeks, 4 weeks, 12 weeks ]
    measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores

  7. Memory span test (digit span) [ Time Frame: 4 weeks, 12 weeks ]
    test for short-term and working memory

  8. test of attention (d2) [ Time Frame: 4 weeks, 12 weeks ]
    test of attention for measurement of concentration

  9. Resting state electroencephalogram (EEG) [ Time Frame: 4 weeks ]
    measurement of resting state electrophysiologic activity as indicated by frequency analysis and rTMS-evoked activity

  10. magnetic resonance imaging (MRI) [ Time Frame: 4 weeks ]
    structural, anatomical, diffusion weighted magnetic resonance imaging

  11. cigarettes [ Time Frame: 4 weeks, 12 weeks ]
    number of smoked cigarettes per week



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318977


Contacts
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Contact: Tobias Hebel, MD +49-941-941-1250 tobias.hebel@medbo.de
Contact: Martin Schecklmann, PhD +49-941-941-1250 martin.schecklmann@medbo.de

Locations
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Czechia
Brno University Hospital Recruiting
Brno, Czechia
Contact: Libor Ustohal         
University Hospital Ostrava Recruiting
Ostrava, Czechia
Contact: Tomas Skront         
Germany
University Hospital Aachen Not yet recruiting
Aachen, Germany
Contact: Timm Pöppl         
University of Regensburg Recruiting
Regensburg, Germany
Contact: Tobias Hebel, MD         
Sponsors and Collaborators
University of Regensburg
University Hospital, Aachen
University Hospital Ostrava
Brno University Hospital
Investigators
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Study Chair: Berthold Langguth, MD, PhD University of Regensburg
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Responsible Party: Berthold Langguth, MD, Ph.D., Clinical Professor, University of Regensburg
ClinicalTrials.gov Identifier: NCT04318977    
Other Study ID Numbers: 19-1616-101
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders