Deep Brain Stimulation (DBS) for the Management of Treatment Refractory Negative Symptoms in Schizophrenia

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Nov 9, 2012

Keywords

ClinConnect Summary

Schizophrenia is a public health challenge with a large proportion of patients suffering from predominantly negative symptoms and who derive no benefit from currently available treatments. Advances in neuroscience have allowed a greater understanding of negative symptoms and have identified key structures and circuits believed to generate and maintain them. Here, we propose the application of a targeted therapy, deep brain stimulation (DBS), to alter the circuits driving negative symptoms. This is a phase I, non-blinded, non-randomized, pilot trial, exploring the safety and efficacy of DBS ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or Female patients between the age of 25-65
• • DSM IV-TR diagnosis of Schizophrenia Predominant Negative Subtype, as determined by the SANS and the Schedule for the Deficit Syndrome (SDS)
• • Greater negative than positive scores on the Positive and Negative Symptoms of Schizophrenia Scale (PANSS)
• • Confirmation of diagnosis by independent, non-study affiliated psychiatrist
• • Disease duration of \> 5 years
• * Failure of medical therapy, defined as follows:
• • Failure of a minimum of three anti-psychotic treatments for specifically negative symptoms of schizophrenia (including clozapine)
• • No underlying neurological disease - No other active Axis I or Axis II co-morbidity that is the focus of clinical attention
• • Able to give informed consent: i)Deemed competent by two independent psychiatrists (one study psychiatrist and one non-study psychiatrist); ii) Score of \> 70 on MacCat-CR
• • Able to comply with all testing and follow-up visit requirements defined by the Study Protocol
• • Mini mental status examination (MMSE)score \> 25
• • Pre-menopausal women must agree to use acceptable methods of birth control (radiation risk of PET)
• Exclusion Criteria:
• • Alcohol or substance dependence or abuse within 6 months, excluding nicotine or caffeine.
• • Current suicidal ideation, plan or intent for self-harm.
• • A suicide attempt in the past 1 year
• • Diagnosis of Major Depressive Disorder or Bipolar Depression
• • Major medical illness, cardiac pacemaker/defibrillator, and other implanted stimulator
• • Likely to relocate or move to a location distant from the study site within one year of enrollment
• • Any contraindication to MRI or PET scanning
• • Inability to provide consent, as well as an inability to appreciate the details and risk of the trial's procedures; competence will be assessed by two independent psychiatrists (one study psychiatrist, and one non-study psychiatrist)