TMS in Treatment of Schizophrenia Negative Symptoms

Not Applicable

• Conditions: Schizophrenia
• Interventions: Device: HR rTMS; Device: sham

• Registration Number: NCT04268797
• Lead Sponsor: Sveti Ivan Psychiatric Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-04
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-13
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19
• Primary Completion: 2022-12-15
• Study Completion: 2023-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HR rTMS H7-coil intervention group	HR rTMS	-
sham control group	sham	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 of BNSS score	assessed up to 20 days of treatment	Change in Brief Negative Symptom Scale (BNSS), (Kirkpatrick et al., 2006)
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)

Trial Locations

Locations (1)

PB Sveti Ivan; 🇭🇷 Zagreb, Croatia