Repetitive Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia

Refractory Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386918
• Other study ID #: 127/2003
• Status: Completed
• Phase: N/A
• First received: June 29, 2011
• Last updated: January 4, 2012
• Start date: February 2004
• Est. completion date: January 2009

Study information

• Verified date: January 2012
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hallucinations
• Refractory Schizophrenia
• Schizophrenia

Intervention

Device:
• repetitive Transcranial Magnetic Stimulation
The treatment involves the administration of a magnetic field applied to a specific area of the brain.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Canadian Institutes of Health Research (CIHR), National Alliance for Research on Schizophrenia and Depression, Ontario Mental Health Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychotic Symptoms Rating Scale (PSYRATS)	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)	4 weeks	No
Secondary	Positive and Negative Symptom Scale - Global	response on the global PANSS (30% reduction), PANSS global scale change	4 weeks	No
Secondary	Positive and Negative Symptom Scale - Positive subscale	response on the positive scale of the PANSS (30% reduction), PANSS positive scale change	4 weeks	No
Secondary	Hallucination Change Scale	response on the HCS (score < 5)	4 weeks	No
Secondary	Auditory Hallucination Rating Scale (AHRS)	response on the AHRS and change over time in the AHRS.	4 weeks	No

External Links

•   Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating Centre