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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR rTMS H7-coil intervention group | Experimental |
| |
| sham control group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR rTMS | Device | high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted 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 | assessed up to 20 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SNS score | Change in Self-Evaluation of Negative Symptoms Scale (SNS) (Dollfus, Mach and Morello, 2016) | assessed up to 20 days of treatment |
| Change of BNSS score | Change in Brief Negative Symptom Scale (BNSS), (Kirkpatrick et al., 2006) |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients self-reported side effects during therapy, confirmed by the medical nurse | assessed up to 20 days of treatment | |
| Change in verbal memory | Change in verbal memory using Auditory Verbal Learning Test (AVLT), subtest from Wechsler Memory Scale (Revised)-Verbal-Logical Memory |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PB Sveti Ivan | Recruiting | Zagreb | 10000 | Croatia |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| sham | Device | SHAM HF rTMS coil once daily x 20 days |
|
| 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) | 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) | assessed up to 20 days of treatment |
| assessed up to 20 days of treatment |
| Change in visual memory | Change in visual memory using Benton's visual retention test (BVRT) | assessed up to 20 days of treatment |
| Change in numeric memory | Change in numeric memory using subtest from Wechsler Memory Scale (Revised)-Digit Span | assessed up to 20 days of treatment |
| Change in visual-spatial abilities and executive function | Change in visual-spatial abilities and executive function using TMT (A/B) Trail Making Test, and subtest from Wechsler Intelligence Scale (Revised)-Block Design | assessed up to 20 days of treatment |
| Change in psihomotor speed | Change in psihomotor speed using subtest from Wechsler Intelligence Scale (Revised)-Digit Symbol Substitution Test | assessed up to 20 days of treatment |
| Change in verbal fluency | Change in verbal fluency using FAS Verbal Fluency Test | assessed up to 20 days of treatment |
| Change in recognition of facial expressions of emotions | Change in recognition of facial expressions of emotions using the Penn's Emotion Recognition Task test (ER40) | assessed up to 20 days of treatment |