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Completed

NCT Number: NCT01015001

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

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.

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Key information

Conditions

Schizophrenia Auditory Hallucinations Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Treatment-Resistant Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active rTMS x sham (placebo) rTMS

Procedure

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

sham rTMS

Procedure

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

Other names: Sham

(1Hz) rTMS applied over the left temporoparietal cortex

Procedure

20 sessions lasting 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 17, 2009
Registry last updated
Aug 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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