A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Active rTMS
1Hz rTMS sessions applied to the left temporoparietal cortex of the subjects
Intervention: Active rTMS x sham (placebo) rTMS (Procedure)
Active rTMS
1Hz rTMS sessions applied to the left temporoparietal cortex of the subjects
Intervention: (1Hz) rTMS applied over the left temporoparietal cortex (Procedure)
Sham rtms
Same number of pulses but applied with and angled coil (90 degrees) and placed over the fronto´temporal region
Intervention: Active rTMS x sham (placebo) rTMS (Procedure)
Sham rtms
Same number of pulses but applied with and angled coil (90 degrees) and placed over the fronto´temporal region
Intervention: sham rTMS (Procedure)
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.(2 years)