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

• Sponsor: Hospital de Clinicas de Porto Alegre (Other)
• Overall Status: Completed
• CT.gov ID: NCT01015001
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 1.1

Study Details

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.

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 Design

• Study Type: Interventional
• 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 1, 2008
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

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 Names: 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 Names: EMTr ; Procedure: sham rTMS; same coil, same number of pulses but using an angled coil(90degres) over the frontotemporal region; Other Names: Sham

Outcome Measures

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. [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. [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01015001
• Other Study ID Numbers: 06382
• First Posted: Nov 17, 2009
• Last Update Posted: Aug 12, 2010
• Last Verified: Aug 1, 2010

• Keywords provided by , ,: refractory schizophrenia; rTMS; auditory hallucinations
• Additional relevant MeSH terms: Hallucinations; Schizophrenia

Study Results

No Results Posted as of Aug 12, 2010