Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
104 participants
INTERVENTIONAL
2019-11-04
2023-03-15
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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HR rTMS H7-coil intervention group
HR rTMS
high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days
sham control group
sham
SHAM HF rTMS coil once daily x 20 days
Interventions
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HR rTMS
high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days
sham
SHAM HF rTMS coil once daily x 20 days
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
ALL
No
Sponsors
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Sveti Ivan Psychiatric Hospital
OTHER
Responsible Party
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Locations
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PB Sveti Ivan
Zagreb, , Croatia
Countries
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Facility Contacts
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Other Identifiers
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TMS_negative symptoms
Identifier Type: -
Identifier Source: org_study_id
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