Hippocampus DBS in Treatment-resistant Schizophrenia
Treatment-resistant Schizophrenia
About this trial
This is an interventional treatment trial for Treatment-resistant Schizophrenia
Eligibility Criteria
Inclusion Criteria: Male or female aged between 18 and 55 years. Having a diagnosis of schizophrenia according to DSM-IV criteria Having a chronic, recurrent course of disease with a five-year minimum duration Determined to be treatment-resistant as demonstrated by: Persistence of positive symptoms which have not responded to appropriate treatments for at least 2 years. Inadequate response from adequate trials of two different classes of antipsychotic drugs (not including clozapine), at least 8 weeks. Inadequate response from adequate trial of clozapine, at least 3 months, or unable to tolerate clozapine because of intolerable side effects. Presence of persistent positive symptom defined as i) requiring a score of 4 (moderate) or more on at least 2 of the next PANSS items: delusions, conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content; or as ii) requiring a score of 6 (severe) or more on at least 1 of the above PANSS items. Maintaining stable pharmacological treatment for two months preceding screening visit. Informed consent Exclusion Criteria: Neurological disease Severe physical illness Contraindications to neurosurgery, MRI or PET-CT; Substance abuse or dependence Mental retardation Female patients who are pregnant or breastfeeding Severe suicide risk and tendencies
Sites / Locations
- Shanghai Mental Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
On-Stimulation
Off-Stimulation
Disease condition is assessed with stimulation turned "on".
Disease condition is assessed with stimulation turned "off".