A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine

Hospital de Clinicas de Porto Alegre20 enrolled

Overview

The primary outcome of this study is to evaluate the effects of low frequency subthreshold repetitive Transcranial Magnetic Stimulation applied to the left temporoparietal cortex of patients with refractory schizophrenia on the severity of auditory hallucinations. The secondary outcome is to evaluate the effects of the same rTMS protocol on quality of life, functionality and general psychopathology.

Seventeen patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups. First group received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC). Second group received sham (placebo) stimulation over the LTPC for the same period of time. All patients were considered as having refractory schizophrenia and in use of at least 400mg/day of clozapine and refering auditory hallucinations occuring at least 5 times a day.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Schizophrenia Auditory Hallucinations

Interventions

Active rTMS x sham (placebo) rTMSPROCEDURE

Seventeen right-handed patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups. One arm received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC). The other arm received sham (placebo) stimulation over the LTPC for the same period of time. All patients were considered as having refractory schizophrenia and in use of at least 400mg/day of clozapine and referred auditory hallucinations.

sham rTMSPROCEDURE

same coil, same number of pulses but using an angled coil(90degres) over the frontotemporal region

(1Hz) rTMS applied over the left temporoparietal cortexPROCEDURE

20 sessions lasting 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with DSM IV TR diagnose of schizophrenia with treatment-resistant auditory hallucinations. * Use of at least 400mg/day of clozapine * Men and women from 18 to 65 years old * Fertile women must be using adequate contraceptive method * BPRS score of at least 27 Exclusion Criteria: * Suicide risk * Patients with epilepsy, brain surgery and/or head trauma in the past, use of cardiac pace maker or metalic clip in the head * Diagnose of substance abuse/dependance * Severe uncontrolled organic disease that may interfere in the patient´s participation in the study * Any other reason that, in the investigator´s opinion, might interfere with the patient´s participation in the study, such as non compliance.

Outcomes

Primary Outcomes

Evaluate the effects of low frequency repetitive Transcranial Magnetic Stimulation applied over the left temporoparietal cortex of refractory schizophrenic patients on the severity of auditory hallucinations.

Time frame: 2 years

Secondary Outcomes

The secondary outcomes are to evaluate the effects of the same rTMS protocol on their quality of life, functionality and general psychopathology.