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

Hospital de Clinicas de Porto Alegre

Status and phase: Completed; Phase 3

Conditions: Auditory Hallucinations; Schizophrenia

Treatments: Procedure: sham rTMS; Procedure: (1Hz) rTMS applied over the left temporoparietal cortex; Procedure: Active rTMS x sham (placebo) rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT01015001

06382

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Active rTMS

Active Comparator group

Description:

1Hz rTMS sessions applied to the left temporoparietal cortex of the subjects

Treatment:

Procedure: (1Hz) rTMS applied over the left temporoparietal cortex

Procedure: Active rTMS x sham (placebo) rTMS

Sham rtms

Placebo Comparator group

Description:

Same number of pulses but applied with and angled coil (90 degrees) and placed over the fronto´temporal region

Treatment:

Procedure: Active rTMS x sham (placebo) rTMS

Procedure: sham rTMS