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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01015001

Enrollment

Registered

2009-11-17

Start date

2008-05-31

Completion date

2009-12-31

Last updated

2010-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auditory Hallucinations, Schizophrenia

Keywords

refractory schizophrenia, rTMS, auditory hallucinations

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.

Interventions

PROCEDUREActive rTMS x sham (placebo) rTMS

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.

PROCEDUREsham rTMS

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

PROCEDURE(1Hz) rTMS applied over the left temporoparietal cortex

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026