Back to resultsA Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine
Primary Purpose
Schizophrenia, Auditory Hallucinations
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Active rTMS x sham (placebo) rTMS
sham rTMS
(1Hz) rTMS applied over the left temporoparietal cortex
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring refractory schizophrenia, rTMS, auditory hallucinations
Eligibility Criteria
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.
Sites / Locations
- Hospital de Clinicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active rTMS
Sham rtms
Arm Description
1Hz rTMS sessions applied to the left temporoparietal cortex of the subjects
Same number of pulses but applied with and angled coil (90 degrees) and placed over the fronto´temporal region
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The secondary outcomes are to evaluate the effects of the same rTMS protocol on their quality of life, functionality and general psychopathology.
Full Information
NCT ID
NCT01015001
First Posted
November 10, 2009
Last Updated
August 11, 2010
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT01015001
Brief Title
A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine
Official Title
A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Auditory Hallucinations
Keywords
refractory schizophrenia, rTMS, auditory hallucinations
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active rTMS
Arm Type
Active Comparator
Arm Description
1Hz rTMS sessions applied to the left temporoparietal cortex of the subjects
Arm Title
Sham rtms
Arm Type
Placebo Comparator
Arm Description
Same number of pulses but applied with and angled coil (90 degrees) and placed over the fronto´temporal region
Intervention Type
Procedure
Intervention Name(s)
Active rTMS x sham (placebo) rTMS
Other Intervention Name(s)
EMTr
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
sham rTMS
Other Intervention Name(s)
Sham
Intervention Description
same coil, same number of pulses but using an angled coil(90degres) over the frontotemporal region
Intervention Type
Procedure
Intervention Name(s)
(1Hz) rTMS applied over the left temporoparietal cortex
Intervention Description
20 sessions lasting 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The secondary outcomes are to evaluate the effects of the same rTMS protocol on their quality of life, functionality and general psychopathology.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danilo Jesus, Psychiatrist
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paulo B Abreu, phd
Organizational Affiliation
HCPorto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine
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