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

Phase 3

Completed

• Conditions: Auditory Hallucinations; Schizophrenia
• Interventions: Procedure: Active rTMS x sham (placebo) rTMS; Procedure: (1Hz) rTMS applied over the left temporoparietal cortex; Procedure: sham rTMS

• Registration Number: NCT01015001
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-17
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-11
• Last Update Posted: 2010-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active rTMS	Active rTMS x sham (placebo) rTMS	1Hz rTMS sessions applied to the left temporoparietal cortex of the subjects
Active rTMS	(1Hz) rTMS applied over the left temporoparietal cortex	1Hz rTMS sessions applied to the left temporoparietal cortex of the subjects
Sham rtms	Active rTMS x sham (placebo) rTMS	Same number of pulses but applied with and angled coil (90 degrees) and placed over the fronto´temporal region
Sham rtms	sham rTMS	Same number of pulses but applied with and angled coil (90 degrees) and placed over the fronto´temporal region

Primary Outcome Measures

Name	Time	Method
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.	2 years

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes are to evaluate the effects of the same rTMS protocol on their quality of life, functionality and general psychopathology.	2 years

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil