TMS in Treatment of Schizophrenia Negative Symptoms
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
HR rTMS
sham
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Confirmation diagnosis of schizophrenia (ICD-10 F20) using the Mini-International Neuropsychiatric Interview (MINI) (Lecrubier et al., 1997; Sheehan et al., 1998),
- Age 18-55 years,
- Both genders,
- PANSS negative symptoms subscale score >24,
- PANSS positive symptoms subscale score <20,
- Stable condition (no acute psychosis exacerbation, no psychiatric hospitalization because of relapse or worsening of symptoms) during at least three months,
- Stable antipsychotic therapy with no change of drugs or doses during the one months before the enrollment.
Exclusion Criteria:
- Antipsychotics dose change or change of antipsychotic drug,
- Hospitalization for somatic illness in another institution,
- Termination of treatment in a Psychiatric Hospital "Sveti Ivan",
- Pregnancy,
- Missed more than three consecutive interventions,
- Withdrawal of consent to participate for the sake of intolerance of TMS or for other reasons.
Sites / Locations
- PB Sveti IvanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
HR rTMS H7-coil intervention group
sham control group
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in SNS score
Change in Self-Evaluation of Negative Symptoms Scale (SNS) (Dollfus, Mach and Morello, 2016)
Change of BNSS score
Change in Brief Negative Symptom Scale (BNSS), (Kirkpatrick et al., 2006)
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)
Change in CDSS score
Change in depressive symptoms measured using Calgary Depression Scale for Schizophrenia (CDSS) (Addington, Addington and Schissel, 1990)
Full Information
NCT ID
NCT04268797
First Posted
February 7, 2020
Last Updated
May 18, 2022
Sponsor
Sveti Ivan Psychiatric Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04268797
Brief Title
TMS in Treatment of Schizophrenia Negative Symptoms
Official Title
Efficacy and Safety of High-frequency Repetitive Transcranial Magnetic Stimulation With H7-coil in the Treatment of Schizophrenia Negative Symptoms; A Multicenter, Randomized, Sham Controlled, Triple Blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
March 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sveti Ivan Psychiatric Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HR rTMS H7-coil intervention group
Arm Type
Experimental
Arm Title
sham control group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
HR rTMS
Intervention Description
high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days
Intervention Type
Device
Intervention Name(s)
sham
Intervention Description
SHAM HF rTMS coil once daily x 20 days
Primary Outcome Measure Information:
Title
Adjusted median of differences in total SANS score
Description
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
Secondary Outcome Measure Information:
Title
Change in SNS score
Description
Change in Self-Evaluation of Negative Symptoms Scale (SNS) (Dollfus, Mach and Morello, 2016)
Time Frame
assessed up to 20 days of treatment
Title
Change of BNSS score
Description
Change in Brief Negative Symptom Scale (BNSS), (Kirkpatrick et al., 2006)
Time Frame
assessed up to 20 days of treatment
Title
Change in PANSS negative symptom subscale with items rescaled to 0-6 range
Description
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
Title
Change in CDSS score
Description
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
Other Pre-specified Outcome Measures:
Title
The number of patients self-reported side effects during therapy, confirmed by the medical nurse
Time Frame
assessed up to 20 days of treatment
Title
Change in verbal memory
Description
Change in verbal memory using Auditory Verbal Learning Test (AVLT), subtest from Wechsler Memory Scale (Revised)-Verbal-Logical Memory
Time Frame
assessed up to 20 days of treatment
Title
Change in visual memory
Description
Change in visual memory using Benton's visual retention test (BVRT)
Time Frame
assessed up to 20 days of treatment
Title
Change in numeric memory
Description
Change in numeric memory using subtest from Wechsler Memory Scale (Revised)-Digit Span
Time Frame
assessed up to 20 days of treatment
Title
Change in visual-spatial abilities and executive function
Description
Change in visual-spatial abilities and executive function using TMT (A/B) Trail Making Test, and subtest from Wechsler Intelligence Scale (Revised)-Block Design
Time Frame
assessed up to 20 days of treatment
Title
Change in psihomotor speed
Description
Change in psihomotor speed using subtest from Wechsler Intelligence Scale (Revised)-Digit Symbol Substitution Test
Time Frame
assessed up to 20 days of treatment
Title
Change in verbal fluency
Description
Change in verbal fluency using FAS Verbal Fluency Test
Time Frame
assessed up to 20 days of treatment
Title
Change in recognition of facial expressions of emotions
Description
Change in recognition of facial expressions of emotions using the Penn's Emotion Recognition Task test (ER40)
Time Frame
assessed up to 20 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmation diagnosis of schizophrenia (ICD-10 F20) using the Mini-International Neuropsychiatric Interview (MINI) (Lecrubier et al., 1997; Sheehan et al., 1998),
Age 18-55 years,
Both genders,
PANSS negative symptoms subscale score >24,
PANSS positive symptoms subscale score <20,
Stable condition (no acute psychosis exacerbation, no psychiatric hospitalization because of relapse or worsening of symptoms) during at least three months,
Stable antipsychotic therapy with no change of drugs or doses during the one months before the enrollment.
Exclusion Criteria:
Antipsychotics dose change or change of antipsychotic drug,
Hospitalization for somatic illness in another institution,
Termination of treatment in a Psychiatric Hospital "Sveti Ivan",
Pregnancy,
Missed more than three consecutive interventions,
Withdrawal of consent to participate for the sake of intolerance of TMS or for other reasons.
Facility Information:
Facility Name
PB Sveti Ivan
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ena Ivezic, MA
Phone
38513430171
Email
ena.ivezic@pbsvi.hr
12. IPD Sharing Statement
Plan to Share IPD
No
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TMS in Treatment of Schizophrenia Negative Symptoms
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