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Tests treatment safety and results for Deep Brain Stimulation
Official title Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders
ClinicalTrials.gov ID: NCT06112067
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Treatment refractory obsessive-compulsive disorder:
- Aged 18\~65 when signing informed consent, outpatient or inpatient, male or female.
- Fits DSM-5 obsessive-compulsive disorder criteria.
- Fits treatment refractory obsessive-compulsive disorder criteria (both i and ii): i.Treated with at least 3 kinds of serotonin reuptake inhibitors...
- Treatment refractory schizophrenia:
You likely can't join if
- With mental disorders including physical mental disorders, paranoid personality disorder, delayed mental development etc.
- Through clinical evaluation by investigators, there exists significant suicide behavior risk.
- From screening period to baseline, patients who has significant improvement in evaluation scores:
- Obsessive compulsive disorder: Y-BOCS score decreased (or improved) ≥ 20%
- Schizophrenia: PANSS score decreased (or improved) ≥ 20%
- Bipolar with depression: MADRS score decreased (or improved) ≥ 20%
See the full eligibility criteria
Who can join
- Treatment refractory obsessive-compulsive disorder:
- Aged 18\~65 when signing informed consent, outpatient or inpatient, male or female.
- Fits DSM-5 obsessive-compulsive disorder criteria.
- 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...
- Treatment refractory schizophrenia:
- Aged 18\~65 when signing informed consent, outpatient or inpatient, male or female.
- Fits DSM-5 schizophrenia criteria.
- Course of disorder ≥ 5 years.
- Fits treatment refractory schizophrenia criteria, one of the conditions below: i.Treated with more than 2 different anti-psychotic medications (clozapine excluded), enough dosage (equivalent dosage as chlorpromazine ≥...
- Treatment refractory bipolar with depression:
- Aged 18\~65 when signing informed consent, outpatient or inpatient, male or female.
- Fits DSM-5 bipolar I or bipolar II criteria, currently with depression episode.
- Course of disorder ≥ 2 years.
- Fits treatment refractory bipolar with depression criteria (treated with two different kinds of treatment below, enough dosage and enough course of treatment ≥ 8 weeks, and cannot acquire symptom cure for 8 consecutive...
- Treatment refractory anorexia nervosa:
- Aged 18\~65 when signing informed consent, outpatient or inpatient, male or female.
- Fits DSM-5 anorexia nervosa criteria, consider both restricting type and binge-eating/purging type.
- 10 ≤ BMI \< 16 in screening period and baseline.
- Fits treatment refractory anorexia nervosa criteria (both i, ii, iii and iv): i.Course of disorder ≥ 5 years, severe and sustained anorexia nervosa. ii.With ≥ 3 times repeated inpatient history and bad treatment effect...
- Gambling disorder:
- Aged 18\~65 when signing informed consent, outpatient or inpatient, male or female.
- Course of disorder ≥ 2 years.
- Diagnosed as gambling disorder based on DSM-5, fits medium or severe diagnostic standard (≥ 6 terms)
- Received systemic treatment (such as medication and social mental intervention) but still has iterative thoughts of impulse or gambling behaviors.
- Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.
- Adult autism:
- Aged 18\~65 when signing informed consent, outpatient or inpatient, male or female.
- Fits DSM-5 autism spectrum disorder diagnostic standard, and there's severe, life-threatening iterative behaviors, and independently evaluated by two psychiatric doctors.
- AuBC score ≥ 62 in screening period and baseline.
- CGI-S score ≥ 4 in screening period and baseline.
- Course of disorder ≥ 10 years, received systemic behavior intervention or training ( such as critical reaction training, cognitive behavior intervention, language expression training, demonstration method, natural...
- Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.
What rules you out
- With mental disorders including physical mental disorders, paranoid personality disorder, delayed mental development etc.
- Through clinical evaluation by investigators, there exists significant suicide behavior risk.
- From screening period to baseline, patients who has significant improvement in evaluation scores:
- Obsessive compulsive disorder: Y-BOCS score decreased (or improved) ≥ 20%
- Schizophrenia: PANSS score decreased (or improved) ≥ 20%
- Bipolar with depression: MADRS score decreased (or improved) ≥ 20%
- Anorexia nervosa: BMI improved ≥ 20%
- Gambling: through evaluation by investigators, online gambling behavior is significantly improved
- Adult autism: AuBC score decreased (or improved) ≥ 20%.
- With severe or unstable cardiovascular, inspiratory, liver, kidney, blood, endocrine, neural system or other system disorders.
- Has neural system disorders including physical brain disorders, brain trauma, treatment-refractory seizure etc.
- During screening period or baseline, abnormalities in patient's physical examination, laboratory examination, electrocardiogram examination, imaging examination have significant clinical meaning, and patients who are...
- Implanted artificial cochlea, pacemaker, similar single-side or double-side products or experienced other physical surgeries within half a year that are considered to have effect on this trial by investigators.
- DBS implant surgery taboos present and is considered unfit by investigators.
- Diagnosed as HIV positive.
- Female in gestation, lactation, or blood HCG / urine gestation test positive. Or patients who can't take effective contraception actions during the trial. Or patients planning to birth or give birth after the trial...
- Currently involved or involved in other medication or medical device clinical trials 3 months before the screening period.
- Other patients who are considered unfit by investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.