A double-blind randomised controlled trial of repetitive Transcranial Magnetic Stimulation (rTMS) in the treatment of persistent auditory hallucinations in schizophrenia

Not Applicable

Completed

Conditions: Mental and Behavioural Disorders: Schizophrenia
Mental and Behavioural Disorders
Schizophrenia

Registration Number: ISRCTN72210184

Lead Sponsor: Department of Health (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 126

Inclusion Criteria

1. Male and female, aged 18 to 65
2. Subjects will fulfil the Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) diagnostic criteria for schizophrenia.
3. They will also continue to experience auditory hallucinations defined as a score of more than two on the auditory hallucinations sub-scale of the Scale for the Assessment of Positive Symptoms (SAPS) for more than six weeks despite standard clinical treatment by a psychiatric team.

Exclusion Criteria

1. Organic brain disorder
2. Previous documented unconsciousness
3. Unstable coronary heart disease
4. Contra-indications to rTMS, e.g. history of fits, recent cerebro-vascular accident, history of epileptic seizures, metal implants, cardiac pacemakers

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change from baseline in auditory hallucinations score according to a visual analogue measure of current intensity, as used by Hoffman et al (2000).<br>2. Change from baseline in the auditory hallucinations sub-scale score from SAPS as a measure of frequency of auditory hallucinations over the past week.

Secondary Outcome Measures

Name	Time	Method
1. Complete SAPS and Scale for the Assessment of Negative Symptoms (SANS) scores as a measure of change in total schizophrenic symptoms.<br>2. 17-item Hamilton Depression Rating Scale (HAMD) as a measure of change in mood. The HAMD is the most commonly used measure for treatment trials of depression, and has been widely applied to this end in reported trials using rTMS.<br>3. Changes in physical, psychological and social functioning are assessed with the Short Form 36 Health Survey Questionnaire (SF-36).<br>4. Medication type and levels are recorded at all assessment points.<br>5. rTMS side effects are recorded at all assessment points.<br>6. Neuropsychological and audiometric tests are carried out before and after the treatment phase of the trial.<br>7. Patient satisfaction will be assessed after the treatment phase.<br>8. 'Blindness' of subjects and assessors will be assessed after the treatment phase.