Repetitive transcranial magnetic stimulation for the treatment of negative symptoms in residual schizophrenia: rationale and design of a sham-controlled, randomized multicenter study

Cordes, Joachim and Falkai, P. and Guse, B. and Hasan, A. and Schneider-Axmann, T. and Arends, M. and Winterer, G. and Woelwer, W. and Ben Sliman, E. and Ramacher, M. and Schmidt-Kraepelin, C. and Ohmann, C. and Langguth, B. and Landgrebe, M. and Eichhammer, P. and Frank, E. and Burger, J. and Hajak, G. and Rietschel, M. and Wobrock, T. (2009) Repetitive transcranial magnetic stimulation for the treatment of negative symptoms in residual schizophrenia: rationale and design of a sham-controlled, randomized multicenter study. EUROPEAN ARCHIVES OF PSYCHIATRY AND CLINICAL NEUROSCIENCE, 259. pp. 189-197. ISSN 0940-1334, 1433-8491

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Abstract

Current meta-analysis revealed small, but significant effects of repetitive transcranial magnetic stimulation (rTMS) on negative symptoms in patients with schizophrenia. There is a need for further controlled, multicenter trials to assess the clinical efficacy of rTMS on negative symptoms in schizophrenia in a larger sample of patients. The objective of this multicenter, randomized, sham-controlled, rater- and patient-blind clinical trial is to investigate the efficacy of 3-week 10-Hz high frequency rTMS add on to antipsychotic therapy, 15 sessions per 3 weeks, 1,000 stimuli per session, stimulation intensity 110% of the individual motor threshold) of the left dorsolateral prefrontal cortex for treating negative symptoms in schizophrenia, and to evaluate the effect during a 12 weeks of follow-up. The primary efficacy endpoint is a reduction of negative symptoms as assessed by the negative sum score of the positive and negative symptom score (PANSS). A sample size of 63 in each group will have 80% power to detect an effect size of 0.50. Data analysis will be based on the intention to treat population. The study will be conducted at three university hospitals in Germany. This study will provide information about the efficacy of rTMS in the treatment of negative symptoms. In addition to psychopathology, other outcome measures such as neurocognition, social functioning, quality of life and neurobiological parameters will be assessed to investigate basic mechanisms of rTMS in schizophrenia. Main limitations of the trial are the potential influence of antipsychotic dosage changes and the difficulty to ensure adequate blinding.

Item Type: Article
Uncontrolled Keywords: BIOLOGICAL-PSYCHIATRY WFSBP; HANS RATING-SCALE; DEPRESSION SCALE; WORLD-FEDERATION; CONTROLLED-TRIAL; BRAIN; GUIDELINES; SOCIETIES; TMS; Residual schizophrenia; Repetitive transcranial magnetic stimulation; Neurobiology
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Psychiatrie und Psychotherapie
Depositing User: Dr. Gernot Deinzer
Date Deposited: 02 Sep 2020 08:18
Last Modified: 02 Sep 2020 08:18
URI: https://pred.uni-regensburg.de/id/eprint/28176

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