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Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia (RESIS)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00783120
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : November 3, 2013
Sponsor:
Collaborator:
University of Göttingen
Information provided by:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Study Description
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Brief Summary:

Schizophrenia is a major psychotic disorder that presents an enormous burden to the patients and their relatives. Despite treatment with second generation antipsychotics, negative symptoms and cognitive impairment often persist and determine an unfavourable course including reduction in life quality. Prefrontal repetitive transcranial magnetic stimulation (rTMS), a promising noninvasive biological technique, applied adjuvant to ongoing antipsychotic treatment was demonstrated to be safe and was associated with improvement in negative symptoms in the majority of the small placebo-controlled trials.

The primary objective of the trial is to investigate the efficacy of high-frequency rTMS (add-on to antipsychotic therapy) in the treatment of negative symptoms in schizophrenia compared to sham stimulation (placebo).


Condition or disease Intervention/treatment Phase
Schizophrenia Other: Repetitive transcranial magnetic stimulation Other: Sham repetitive transcranial magnetic stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia - a Multicenter Study
Study Start Date : January 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) (15 sessions/3 weeks, 1000 stimuli per session, stimulation intensity 110 % related to the individual resting motor threshold).
 Other: Repetitive transcranial magnetic stimulation
10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) (15 sessions/3 weeks, 1000 stimuli per session, stimulation intensity 110 % related to the individual resting motor threshold); in total 15.000 stimuli.
Sham Comparator: 2
placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session)
 Other: Sham repetitive transcranial magnetic stimulation
placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session; in total 15.000 stimuli


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score) [ Time Frame: 105 Days ]

Secondary Outcome Measures :
  1. efficacy on cognition, EPS, neuroplasticity (sMRI/MRS), depression, life quality and social function [ Time Frame: 105 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female in-patients and out-patients, 18 - 60 years of age
  • Diagnostic criteria for schizophrenia according to ICD-10/DSM IV
  • PANSS negative sum score > 20 points, 1 of items N1 - N7 (range 1 to 7) ≥ 4 (at least moderate)
  • Improvement in PANSS negative sum score less than 10 % in the last 2 weeks prior to study entry, stable antipsychotic medication
  • Informed Consent

Exclusion Criteria:

  • Clinically relevant psychiatric comorbidity, verbal IQ < 85
  • History of epileptic seizures, organic brain disease
  • Instable medical comorbidity or condition
  • Previous treatment by rTMS
  • Factors not compatible with the use of TMS, e.g. cardiac pace makers or other metallic implants, pregnancy
Contacts and Locations
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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): NCT00783120


Locations
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Germany
Department of Psychiatry and Psychotherapy, University of Regensburg
Regensburg, Bayern, Germany, 93053
Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen
Goettingen, Niedersachsen, Germany, 37075
Department of Psychiatry, Heinrich-Heine University Hospital
Duesseldorf, Nordrhein-Westfalen, Germany, 40629
Sponsors and Collaborators
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
University of Göttingen
Investigators
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Study Director: Peter G Falkai, Prof MD. Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. MD. Peter Falkai, Dept. of Psychiatry and Psychotherapy
ClinicalTrials.gov Identifier: NCT00783120    
Other Study ID Numbers: RESIS
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: November 3, 2013
Last Verified: November 2013
Keywords provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:
schizophrenia, negative symptoms, TMS, magnetic stimulation
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders