A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Auditory Hallucinations |
Procedure: Active rTMS x sham (placebo) rTMS Procedure: sham rTMS Procedure: (1Hz) rTMS applied over the left temporoparietal cortex |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | May 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Active rTMS
1Hz rTMS sessions applied to the left temporoparietal cortex of the subjects
|
Procedure: 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. Other Name: EMTr
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).
|
|
Placebo Comparator: Sham rtms
Same number of pulses but applied with and angled coil (90 degrees) and placed over the fronto´temporal region
|
Procedure: 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. Other Name: EMTr
Procedure: sham rTMS
same coil, same number of pulses but using an angled coil(90degres) over the frontotemporal region
Other Name: Sham
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| Brazil | |
| Hospital de Clinicas de Porto Alegre | |
| Porto Alegre, Rio Grande do Sul, Brazil | |
| Principal Investigator: | Danilo Jesus, Psychiatrist | Hospital de Clinicas de Porto Alegre |
| Study Director: | Paulo B Abreu, phd | HCPorto Alegre |
More Information
No publications provided
| Responsible Party: | FIPE, Hospital de Clínicas de Porto Alegre |
| ClinicalTrials.gov Identifier: | NCT01015001 History of Changes |
| Other Study ID Numbers: | 06382 |
| Study First Received: | November 10, 2009 |
| Last Updated: | August 11, 2010 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Hospital de Clinicas de Porto Alegre:
|
refractory schizophrenia rTMS auditory hallucinations |
Additional relevant MeSH terms:
|
Hallucinations Schizophrenia Perceptual Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Schizophrenia and Disorders with Psychotic Features Mental Disorders Clozapine Serotonin Antagonists Serotonin Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs GABA Antagonists GABA Agents |
ClinicalTrials.gov processed this record on May 23, 2013