Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia (RESIS)
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|ClinicalTrials.gov Identifier: NCT00783120|
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : November 4, 2013
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||197 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score) [ Time Frame: 105 Days ]
- efficacy on cognition, EPS, neuroplasticity (sMRI/MRS), depression, life quality and social function [ Time Frame: 105 days ]
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
|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|
|Study Director:||Peter G Falkai, Prof MD.||Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen|