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

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ClinicalTrials.gov Identifier: NCT01015001
Recruitment Status : Completed
First Posted : November 17, 2009
Last Update Posted : August 12, 2010
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

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.


Condition or disease Intervention/treatment 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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Clozapine
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015001


Locations
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Danilo Jesus, Psychiatrist Hospital de Clinicas de Porto Alegre
Study Director: Paulo B Abreu, phd HCPorto Alegre

Responsible Party: FIPE, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01015001     History of Changes
Other Study ID Numbers: 06382
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: August 12, 2010
Last Verified: August 2010

Keywords provided by Hospital de Clinicas de Porto Alegre:
refractory schizophrenia
rTMS
auditory hallucinations

Additional relevant MeSH terms:
Schizophrenia
Hallucinations
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Clozapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents