TMS in Treatment of Schizophrenia Negative Symptoms

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04268797
• Other study ID #: TMS_negative symptoms
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Schizophrenia

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