NCT04268797

TMS in Treatment of Schizophrenia Negative Symptoms

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Sveti Ivan Psychiatric Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DEVICE	HR rTMS	high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days
DEVICE	sham	SHAM HF rTMS coil once daily x 20 days

Timeline

• Start date: 2019-11-04
• Primary completion: 2022-12-15
• Completion: 2023-03-15
• First posted: 2020-02-13
• Last updated: 2022-05-19

Locations

1 site across 1 country: Croatia