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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04268797
Other study ID # TMS_negative symptoms
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 4, 2019
Est. completion date March 15, 2023

Study information

Verified date May 2022
Source Sveti Ivan Psychiatric Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 104
Est. completion date March 15, 2023
Est. primary completion date December 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
Croatia PB Sveti Ivan Zagreb

Sponsors (1)

Lead Sponsor Collaborator
Sveti Ivan Psychiatric Hospital

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Other The number of patients self-reported side effects during therapy, confirmed by the medical nurse assessed up to 20 days of treatment
Other Change in verbal memory Change in verbal memory using Auditory Verbal Learning Test (AVLT), subtest from Wechsler Memory Scale (Revised)-Verbal-Logical Memory assessed up to 20 days of treatment
Other Change in visual memory Change in visual memory using Benton's visual retention test (BVRT) assessed up to 20 days of treatment
Other Change in numeric memory Change in numeric memory using subtest from Wechsler Memory Scale (Revised)-Digit Span assessed up to 20 days of treatment
Other 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
Other 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
Other Change in verbal fluency Change in verbal fluency using FAS Verbal Fluency Test assessed up to 20 days of treatment
Other 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
Primary 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
Secondary 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
Secondary Change of BNSS score Change in Brief Negative Symptom Scale (BNSS), (Kirkpatrick et al., 2006) assessed up to 20 days of treatment
Secondary 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
Secondary 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
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