Archival ReportLeft Prefrontal High-Frequency Repetitive Transcranial Magnetic Stimulation for the Treatment of Schizophrenia with Predominant Negative Symptoms: A Sham-Controlled, Randomized Multicenter Trial
Section snippets
Methods And Materials
Written informed consent was obtained from all subjects after complete description of the study. The local ethics committees approved the protocol, which was conducted in accordance with the Declaration of Helsinki.
Study Subjects
The investigators screened 197 patients, until the recruitment objective was reached. A total of 175 patients were enrolled and randomly assigned into a treatment group. After a 2-week period of assessment of eligibility, 157 patients received either active (n = 76) or sham (n = 81) rTMS treatment; 127 patients remained in the sample at day 21 (see Supplement 1 for dropout analysis and Consolidated Standards of Reporting Trials diagram). Study patients were selected based on having clinically
Discussion
Compared with sham rTMS, augmentation of antipsychotic medication with active 10-Hz rTMS applied to the left DLPFC in patients with predominant negative symptoms of schizophrenia did not offer a benefit for the target symptoms over the 3-week, rater-blind and patient-blind portion or during the extension phase of this study. The global severity of illness and the severity of negative symptoms in this patient group were high, comparable in these domains to patients with refractory forms of
Acknowledgments And Disclosures
This work was supported by the Deutsche Forschungsgemeinschaft Grant No. FA–210/1. The trial protocol has been published (30) and is available at [email protected].
TW has received paid speakerships from Alpine Biomed, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, I3G, Janssen-Cilag, Novartis, Lundbeck, Roche, Sanofi-Aventis, Otsuka, and Pfizer; has accepted travel or hospitality not related to a speaking engagement from AstraZeneca, Bristol-Myers Squibb, Eli Lilly and
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