A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine
NCT ID: NCT01015001
Last Updated: 2010-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2008-05-31
2009-12-31
Brief Summary
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The secondary outcome is to evaluate the effects of the same rTMS protocol on quality of life, functionality and general psychopathology.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active rTMS
1Hz rTMS sessions applied to the left temporoparietal cortex of the subjects
Active 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.
(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).
Sham rtms
Same number of pulses but applied with and angled coil (90 degrees) and placed over the fronto´temporal region
Active 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.
sham rTMS
same coil, same number of pulses but using an angled coil(90degres) over the frontotemporal region
Interventions
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Active 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.
sham rTMS
same coil, same number of pulses but using an angled coil(90degres) over the frontotemporal region
(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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Hospital de Clínicas de Porto Alegre
Principal Investigators
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Danilo Jesus, Psychiatrist
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clinicas de Porto Alegre
Paulo B Abreu, phd
Role: STUDY_DIRECTOR
HCPorto Alegre
Locations
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Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Other Identifiers
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06382
Identifier Type: -
Identifier Source: org_study_id
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