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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015001
• Other study ID #: 06382
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2009
• Last updated: August 11, 2010
• Start date: May 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2010
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Auditory Hallucinations
• Hallucinations
• Schizophrenia

Intervention

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.
• sham rTMS
same coil, same number of pulses but using an angled coil(90degres) over the frontotemporal region
• (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).

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The secondary outcomes are to evaluate the effects of the same rTMS protocol on their quality of life, functionality and general psychopathology.		2 years	No