Clinical trial NCT04268797: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Sveti Ivan Psychiatric Hospital
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adjusted median of differences in total SANS score
timeFrame: assessed up to 20 days of treatment
Secondary outcomes:
measure: Change in SNS score
timeFrame: assessed up to 20 days of treatment
measure: Change of BNSS score
timeFrame: assessed up to 20 days of treatment
measure: Change in PANSS negative symptom subscale with items rescaled to 0-6 range
timeFrame: assessed up to 20 days of treatment
measure: Change in CDSS score
timeFrame: assessed up to 20 days of treatment
Other outcomes:
measure: The number of patients self-reported side effects during therapy, confirmed by the medical nurse
timeFrame: assessed up to 20 days of treatment
measure: Change in verbal memory
timeFrame: assessed up to 20 days of treatment
measure: Change in visual memory
timeFrame: assessed up to 20 days of treatment
measure: Change in numeric memory
timeFrame: assessed up to 20 days of treatment
measure: Change in visual-spatial abilities and executive function
timeFrame: assessed up to 20 days of treatment
measure: Change in psihomotor speed
timeFrame: assessed up to 20 days of treatment
measure: Change in verbal fluency
timeFrame: assessed up to 20 days of treatment
measure: Change in recognition of facial expressions of emotions
timeFrame: assessed up to 20 days of treatment
Locations:
city: Zagreb
country: Croatia
facility: PB Sveti Ivan
Study officials:
References: