Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders: a Multi-center, Single Arm, Prospective, Open-label, Extendable Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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 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.

• 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 ≥ 600mg/day), enough course of treatment (≥ 12 weeks), no effect or intolerant.

• ii.Treated with enough dosage of clozapine (≥ 300mg/day or blood medication concentration ≥ 350ng/ml, enough course of treatment (≥ 12 weeks), no effect or intolerant.

• e)PANSS score ≥ 70 in screening period and baseline, and at least 1 item from 5 items (P1, P2, P3, P5, P6) of PANSS positive symptom scale ≥ 4; or at least 3 items from PANSS negative symptom scale (N1\

∙ N7) ≥ 4, or at least 2 items ≥ 5.

• f)CGI-S ≥ 4 in screening period and baseline. g)GAF ≤ 60 in screening period and baseline. h)Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.

• 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 weeks, either i or ii):

• i.Used at least two medications (alone) among Olanzapine (10-20mg/d) + Fluoxetine (20-60mg/d), Quetiapine (200-600mg/d), Lurasidone (40-160mg/d), Lamotrigine (200-400mg/d) ii.Used at least one medication above (alone), and used one of medication above with another medication among Lamotrigine (200-400mg/d), Valproate (1000-2000mg/d) and lithium salt (blood lithium reaches 0.8mmol/L).

• e)Upon medication treatment, electroconvulsive therapy ≥ 12 times, no effect or failed (such as intolerant).

• f)Fits severe symptom criteria: i.Depression episode ≥ 12 weeks in screening period. ii.MADRS score ≥ 26 in screening period and baseline. iii.GCI-BP score ≥ 4 in screening period and baseline. iv.YMRS score ≥ 12 in screening period and baseline. g)Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.

• 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 (can't complete treatment or immediate relapse after treatment).

• iii.Through systemic nutrient treatment, medication (SSRIs and/or anti-psychotics), psychotherapies (such as reinforced CBT, FBT treatment), no effect or intolerant.

• iv.Worsened instability of clinical treatment, refuse treatment or bad reaction to reinforced treatment, last for more than 1 year, with more than 2 times of involuntary food intake.

• e)Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.

• 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 environment training, patriarch training, social skill training, intervention based on story tales, etc. ) but failed, or intolerant.

⁃ Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.

Locations
Other Locations
China
Shanghai Mental Health Center
RECRUITING
Shanghai
Contact Information
Primary
Zhen Wang, MD,PhD
wangzhen@smhc.org.cn
862164387250
Time Frame
Start Date: 2023-10-16
Estimated Completion Date: 2026-08
Participants
Target number of participants: 18
Treatments
Experimental: DBS intervention group
This is a single arm, prospective, open label clinical study, participants who fit inclusion standards, don't fit exclusion standards and fit surgical implantation standard will start DBS system stimulation and adjust parameters after 7-14 days of implantation. Then after stimulation for 8-24 weeks, they will be evaluated for treatment efficacies. This study is extendable, with agreements from participants, long term efficacy and safety follow-up study will be performed after 24 weeks ± 7 days, specific plan depends on different mental disorders.
Sponsors
Collaborators: Shanghai 6th People's Hospital, Huashan Hospital, Changhai Hospital, SceneRay Corporation, Limited
Leads: Shanghai Mental Health Center

This content was sourced from clinicaltrials.gov

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