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

This study has been completed.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01015001
First received: November 10, 2009
Last updated: August 11, 2010
Last verified: August 2010
  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

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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. [ 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Perceptual Disorders
Schizophrenia and Disorders with Psychotic Features
Signs and Symptoms
Clozapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014