Repetitive transcranial magnetic stimulation for the treatment of negative symptoms in residual schizophrenia: rationale and design of a sham-controlled, randomized multicenter study.
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.
Cordes
Joachim
J
Department of Psychiatry and Psychotherapy, Heinrich-Heine University of Düsseldorf, Bergische Landstr. 2, 40629 Düsseldorf, Germany. joachim.cordes@lvr.de
Falkai
P
P
Guse
B
B
Hasan
A
A
Schneider-Axmann
T
T
Arends
M
M
Winterer
G
G
Wölwer
W
W
Ben Sliman
E
E
Ramacher
M
M
Schmidt-Kraepelin
C
C
Ohmann
C
C
Langguth
B
B
Landgrebe
M
M
Eichhammer
P
P
Frank
E
E
Burger
J
J
Hajak
G
G
Rietschel
M
M
Wobrock
T
T
D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011569:Psychiatric Status Rating Scales; D018401:Sample Size; D012559:Schizophrenia / Q000628:therapy*; D012565:Schizophrenic Psychology; D050781:Transcranial Magnetic Stimulation; D055815:Young Adult