Schizophrenia
Conditions
Brief summary
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.
Interventions
DEVICEHR rTMS
high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days
DEVICEsham
SHAM HF rTMS coil once daily x 20 days
Sponsors
Sveti Ivan Psychiatric Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmation diagnosis of schizophrenia (ICD-10 F20) using the Mini-International Neuropsychiatric Interview (MINI) (Lecrubier et al., 1997; Sheehan et al., 1998), 2. Age 18-55 years, 3. Both genders, 4. PANSS negative symptoms subscale score \>24, 5. PANSS positive symptoms subscale score \<20, 6. Stable condition (no acute psychosis exacerbation, no psychiatric hospitalization because of relapse or worsening of symptoms) during at least three months, 7. Stable antipsychotic therapy with no change of drugs or doses during the one months before the enrollment.
Exclusion criteria
1. Antipsychotics dose change or change of antipsychotic drug, 2. Hospitalization for somatic illness in another institution, 3. Termination of treatment in a Psychiatric Hospital Sveti Ivan, 4. Pregnancy, 5. Missed more than three consecutive interventions, 6. Withdrawal of consent to participate for the sake of intolerance of TMS or for other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted median of differences in total SANS score | assessed up to 20 days of treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SNS score | assessed up to 20 days of treatment | Change in Self-Evaluation of Negative Symptoms Scale (SNS) (Dollfus, Mach and Morello, 2016) |
| Change of BNSS score | assessed up to 20 days of treatment | Change in Brief Negative Symptom Scale (BNSS), (Kirkpatrick et al., 2006) |
| Change in PANSS negative symptom subscale with items rescaled to 0-6 range | assessed up to 20 days of treatment | Change in PANSS negative symptoms subscale with items rescaled to 0-6 range, (Kay, Fiszbein and Opler, 1987) |
| Change in CDSS score | assessed up to 20 days of treatment | Change in depressive symptoms measured using Calgary Depression Scale for Schizophrenia (CDSS) (Addington, Addington and Schissel, 1990) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in psihomotor speed | assessed up to 20 days of treatment | Change in psihomotor speed using subtest from Wechsler Intelligence Scale (Revised)-Digit Symbol Substitution Test |
| The number of patients self-reported side effects during therapy, confirmed by the medical nurse | assessed up to 20 days of treatment | — |
| Change in recognition of facial expressions of emotions | assessed up to 20 days of treatment | Change in recognition of facial expressions of emotions using the Penn's Emotion Recognition Task test (ER40) |
| Change in verbal fluency | assessed up to 20 days of treatment | Change in verbal fluency using FAS Verbal Fluency Test |
| Change in verbal memory | assessed up to 20 days of treatment | Change in verbal memory using Auditory Verbal Learning Test (AVLT), subtest from Wechsler Memory Scale (Revised)-Verbal-Logical Memory |
| Change in visual memory | assessed up to 20 days of treatment | Change in visual memory using Benton's visual retention test (BVRT) |
| Change in numeric memory | assessed up to 20 days of treatment | Change in numeric memory using subtest from Wechsler Memory Scale (Revised)-Digit Span |
| Change in visual-spatial abilities and executive function | assessed up to 20 days of treatment | Change in visual-spatial abilities and executive function using TMT (A/B) Trail Making Test, and subtest from Wechsler Intelligence Scale (Revised)-Block Design |
Countries
Croatia
Outcome results
None listed