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Completed

NCT Number: NCT01386918

Repetitive Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia

Studies using repetitive transcranial magnetic stimulation (rTMS) as a treatment for refractory auditory hallucinations (AH) in schizophrenia have shown promise. The majority of studies have examined the effect of low frequency left-sided stimulation (LFL) (i.e., 1 Hz) to the temporal parietal cortex (TPC). Priming stimulation (6 Hz) prior to LFL stimulation (hereby simply referred to as priming) has been shown to enhance the neurophysiological effects of LFL rTMS alone and, as such, may lead to greater attenuation of AH. Therefore, this study evaluated the efficacy of priming rTMS and LFL rTMS, compared to sham, applied to the TPC in patients with schizophrenia experiencing refractory auditory hallucinations (AH).

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Key information

Conditions

Refractory Schizophrenia Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Schizophrenia 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

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • voluntary and capable to consent based on the subject's ability to provide a spontaneous narrative description of the key elements of the study
  • have a diagnosis of Schizophrenia or Schizoaffective Disorder as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV)
  • between the ages of 18 and 65
  • meet criteria for AH of at least moderate severity based on the Positive and Negative Symptom Scale (PANSS)
  • willing to keep the dose of antipsychotic stable for the duration of the study
  • meet criteria for medication resistance, defined as daily AH despite 2 adequate 6-week trials of at least 2 antipsychotic medications and including 1 atypical antipsychotic medication. An adequate trial is defined as a daily dose of 1000 chlorpromazine equivalents for typical antipsychotics medications and the following dosages for atypical antipsychotic medications: risperidone 6 mg, olanzapine 15 mg, quetiapine 500 mg, clozapine 300 mg.

Exclusion criteria

  • DSM-IV history of alcohol and/or substance abuse in past month, or alcohol and/or substance dependence in the last 6 months
  • presence of concomitant major, unstable medical or neurologic illness, or a history of seizures
  • are pregnant
  • have received rTMS for any reason in the past
  • have had a dose change of usual psychotropic medications in the 4 weeks preceding study entry.

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

The treatment involves the administration of a magnetic field applied to a specific area of the brain.

Other names: Magstim Rapid (Magstim Company Ltd., Wales, UK)

Primary outcomes

  1. Psychotic Symptoms Rating Scale (PSYRATS)

    Time frame: 4 weeks

    The primary outcome for this study was response (dichotomous outcome), defined as a 30 percent reduction in the composite score derived from the frequency, duration, loudness and content items of the hallucinations subscale of the Psychotic Symptoms Rating Scale (PSYRATS)

Secondary outcomes

  1. Positive and Negative Symptom Scale - Global

    Time frame: 4 weeks

    response on the global PANSS (30% reduction), PANSS global scale change

  2. Positive and Negative Symptom Scale - Positive subscale

    Time frame: 4 weeks

    response on the positive scale of the PANSS (30% reduction), PANSS positive scale change

  3. Hallucination Change Scale

    Time frame: 4 weeks

    response on the HCS (score < 5)

  4. Auditory Hallucination Rating Scale (AHRS)

    Time frame: 4 weeks

    response on the AHRS and change over time in the AHRS.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • National Alliance for Research on Schizophrenia and Depression
  • Ontario Mental Health Foundation

Registry information

Official study title

A Randomized Double-Blind Sham-Controlled Trial of Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Jul 1, 2011
Registry last updated
Jan 6, 2012

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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