Primary objective: to examine the efficacy and safety of high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days, augmentative to the standard antipsychotic pharmacotherapy and other treatment of negative symptoms in schizophrenia. Targeted population: patients diagnosed with schizophrenia, 18-55 years old with predominant negative symptoms, stable condition for \>3 months and unchanged antipsychotic therapy for \>1 months and no treatment with antidepressants. Study design: industry independent, multicenter, prospective randomized sham-controlled, two-arms, triple-blind superiority clinical trial with concealed allocation and masked independent outcome assessment. Primary outcome: adjusted median of differences in total SANS score. Adjustment for age, gender, baseline total SANS score, duration of the disorder, and antipsychotic therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
104
high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days
SHAM HF rTMS coil once daily x 20 days
PB Sveti Ivan
Zagreb, Croatia
RECRUITINGAdjusted median of differences in total SANS score
Adjusted median of differences in total SANS score (Andreasen, 1989). We will adjust the medians for age, gender, baseline total SANS score, duration of the disorder, and antipsychotic therapy
Time frame: assessed up to 20 days of treatment
Change in SNS score
Change in Self-Evaluation of Negative Symptoms Scale (SNS) (Dollfus, Mach and Morello, 2016)
Time frame: assessed up to 20 days of treatment
Change of BNSS score
Change in Brief Negative Symptom Scale (BNSS), (Kirkpatrick et al., 2006)
Time frame: assessed up to 20 days of treatment
Change in PANSS negative symptom subscale with items rescaled to 0-6 range
Change in PANSS negative symptoms subscale with items rescaled to 0-6 range, (Kay, Fiszbein and Opler, 1987)
Time frame: assessed up to 20 days of treatment
Change in CDSS score
Change in depressive symptoms measured using Calgary Depression Scale for Schizophrenia (CDSS) (Addington, Addington and Schissel, 1990)
Time frame: assessed up to 20 days of treatment
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