Deep Brain Stimulation (DBS) for the Management of Treatment Refractory Negative Symptoms in Schi… (NCT01725334) | Clinical Trial Compass
WithdrawnPhase 1
Deep Brain Stimulation (DBS) for the Management of Treatment Refractory Negative Symptoms in Schizophrenia
Stopped: No participants enrolled
Canada0Started 2012-09
Plain-language summary
Schizophrenia is a complex, challenging, and heterogeneous psychiatric condition, affecting up to 0.5% of the population and responsible for nearly 2% of all Canadian health-care expenditure. Much of the morbidity of the illness is related to its negative symptoms, including amotivation, asociality, anhedonia and flattened emotional affect, which lead to functional impairment and withdrawal from social and occupational domains. In contrast to positive symptoms, such as hallucinations and delusions, there are currently no effective treatments for negative symptoms, which experts recognize are largely responsible for the long-term disability of a majority of patients with schizophrenia. 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, to alter the circuits driving negative symptoms.
Who can participate
Age range25 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, a…
What they're measuring
1
Schedule for the Assessment of Negative Symptoms (SANS)
Timeframe: Change from baseline (pre-operative) SANS scores at one-year follow-up