Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders
Trial Parameters
Brief Summary
This is a multi-center, single arm, prospective, open-label, extendable study for the efficacy and safety of combo-stim deep brain stimulation for treatment-refractory mental disorders (obsessive-compulsive disorder, schizophrenia, bipolar with depression, anorexia nervosa, gambling disorder and adult autism).
Eligibility Criteria
Inclusion Criteria: 1. Treatment refractory obsessive-compulsive disorder: 1. Aged 18\~65 when signing informed consent, outpatient or inpatient, male or female. 2. Fits DSM-5 obsessive-compulsive disorder criteria. 3. Fits treatment refractory obsessive-compulsive disorder criteria (both i and ii): i.Treated with at least 3 kinds of serotonin reuptake inhibitors (SSRIs) with at least 2 kinds of 2nd generation antipsychotic medication as enhancement, enough dosage and enough course of treatment, and still no effect or intolerant. ii.While using enough dosage of SSRIs, treated with more than 8\~12 times of Cognitive Behavior Therapy (CBT) or CBT-intolerant. d)Y-BOCS score ≥ 25 in screening period and baseline. e)CGI-S score ≥ 4 in screening period and baseline. f)Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks. 2. Treatment refractory schizophrenia: 1. Aged 18\~65 when signing informed c