Refractory Schizophrenia
Conditions
Keywords
Hallucinations, Schizophrenia
Brief summary
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).
Interventions
DEVICErepetitive Transcranial Magnetic Stimulation
The treatment involves the administration of a magnetic field applied to a specific area of the brain.
Sponsors
Ontario Mental Health Foundation
Canadian Institutes of Health Research (CIHR)
National Alliance for Research on Schizophrenia and Depression
Centre for Addiction and Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychotic Symptoms Rating Scale (PSYRATS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Symptom Scale - Global | 4 weeks | response on the global PANSS (30% reduction), PANSS global scale change |
| Positive and Negative Symptom Scale - Positive subscale | 4 weeks | response on the positive scale of the PANSS (30% reduction), PANSS positive scale change |
| Hallucination Change Scale | 4 weeks | response on the HCS (score \< 5) |
| Auditory Hallucination Rating Scale (AHRS) | 4 weeks | response on the AHRS and change over time in the AHRS. |
Countries
Canada
Outcome results
None listed