TMS in Treatment of Schizophrenia Negative Symptoms

NCT04268797 | Unknown

• 1 other identifier: TMS_negative symptoms
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in SNS score

  assessed up to 20 days of treatment

• Change of BNSS score

  assessed up to 20 days of treatment

• Change in PANSS negative symptom subscale with items rescaled to 0-6 range

  assessed up to 20 days of treatment

• Change in CDSS score

  assessed up to 20 days of treatment

Other Outcomes (8)

• The number of patients self-reported side effects during therapy, confirmed by the medical nurse

  assessed up to 20 days of treatment

• Change in verbal memory

  assessed up to 20 days of treatment

• Change in visual memory

  assessed up to 20 days of treatment

Study Arms (2)

HR rTMS H7-coil intervention group

EXPERIMENTAL

Device: HR rTMS

sham control group

SHAM COMPARATOR

Device: sham

Interventions

HR rTMS DEVICE

high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days

HR rTMS H7-coil intervention group

sham DEVICE

SHAM HF rTMS coil once daily x 20 days

sham control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sveti Ivan Psychiatric Hospital: lead

Study Sites (1)

PB Sveti Ivan

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 13, 2020
• Study Start: November 4, 2019
• Primary Completion: December 15, 2022
• Study Completion: March 15, 2023
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)