A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia

NCT ID: NCT00168311

Last Updated: 2012-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2007-07-31

Brief Summary

There is pilot data to suggest the therapeutic value of rTMS applied to the left prefrontal cortex in the treatment of negative symptoms. Neuroimaging studies demonstrate abnormal activity in this region in patients experiencing negative symptoms. Finally rTMS applied at high frequency shows the capacity to up-regulate cortical activity in a way that would provide an explanation for a therapeutic response.

The study involves participants receiving 15 sessions of high frequency rTMS treatment applied bilaterally to the prefrontal cortex over a 3 week period or sham rTMS. Following this double blind phase, participants randomised to placebo treatment will be offered 15 sessions of active treatment.

In addition, ppTMS (paired pulse TMS) will be conducted prior to the onset of treatment and after completion of the course, as a means of measuring cortical inhibition and facilitation. NIRS (Near Infra red spectroscopy) will also be conducted prior to, during and after the first and last treatment sessions to allow monitoring of oxygenated and deoxygenated haemoglobin.

Detailed Description

The main outcome measure used is the SANS (Scale for the Assessment of Negative Symptoms. This is a semi strucutured interview which provides scores from 0-70. This is administered at baseline, week 2, 3, 5 and 6.

Other outcome measures administered are (frequency mentioned above): PANSS (Positive and Negative Syndrome Scale) and the Calgery Depression Scale for Schizophrenia, A cognitive battery is also administered.

Inclusion Criteria:

• Diagnostic and Statistical Manual-IV diagnosis of schizophrenia or schizoaffective disorder, age over 18
• Persistent negative symptoms of moderate to severe intensity
• Failure to respond to a minimum of two antipsychotic medications
• No increase or initiation of new antipsychotic therapy in the four weeks prior to entering the trial Exclusion Criteria
• Prominent positive symptoms
• Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
• Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker
• Subjects at high risk of violence or suicide as determined by the investigator and treating clinicians
• Substance dependence

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Treatment

Bilateral high frequency (10 Hertz) rTMS

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Participants were sequentially randomly assigned to either 15 active bilateral treatments or 15 sham bilateral treatments that were administered on a daily basis, five days per week.

Sham rTMS

Bilateral Sham rTMS

Group Type: SHAM_COMPARATOR

sham TMS

Intervention Type: DEVICE

Interventions

Transcranial Magnetic Stimulation

Participants were sequentially randomly assigned to either 15 active bilateral treatments or 15 sham bilateral treatments that were administered on a daily basis, five days per week.

Intervention Type: DEVICE

sham TMS

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• DSM-IV diagnosis of schizophrenia or schizoaffective disorder, age over 18
• Persistent negative symptoms of moderate to severe intensity
• Failure to respond to a minimum of two antipsychotic medications
• No increase or initiation of new antipsychotic therapy in the four weeks prior to entering the trial

Exclusion Criteria

• Prominent positive symptoms
• Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
• Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker
• Subjects at high risk of violence or suicide as determined by the investigator and treating clinicians
• Substance dependence

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Alfred

OTHER

Sponsor Role: lead

Responsible Party

Assoc Professor Paul Fitzgerald

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul B Fitzgerald, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Alfred Psychiatry Research Centre

Locations

Alfred Psychiatry Research Centre

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

81/02

Identifier Type: -

Identifier Source: org_study_id