RecruitingNot Applicable

Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders

China18 participantsStarted 2023-10-16

Plain-language 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).

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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):
✓. 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.

Exclusion criteria

✕. 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%

What they're measuring

change of Y-BOCS score compared to baseline after 12 weeks of stimulation

Timeframe: 12 weeks.

reduce rate of PANSS score compared to baseline after 12 weeks of stimulation

Timeframe: 12 weeks

change of Montgomery-Åsberg Depression Rating Scale (MADRS) score compared to baseline after 12 weeks of stimulation

Timeframe: 12 weeks

change of BMI compared to baseline after 12 weeks of stimulation

Timeframe: 12 weeks

the duration of abstinence in gambling disorder

Timeframe: within 24 weeks

change of AuBC score compared to baseline after 12 weeks of stimulation

Timeframe: 12 weeks

Trial details

NCT IDNCT06112067

SponsorShanghai Mental Health Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Zhen Wang, MD,PhD

862164387250 wangzhen@smhc.org.cn

View on ClinicalTrials.gov More Deep Brain Stimulation trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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):
✓. 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.

Exclusion criteria

✕. 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%

What they're measuring

change of Y-BOCS score compared to baseline after 12 weeks of stimulation

Timeframe: 12 weeks.

reduce rate of PANSS score compared to baseline after 12 weeks of stimulation

Timeframe: 12 weeks

change of Montgomery-Åsberg Depression Rating Scale (MADRS) score compared to baseline after 12 weeks of stimulation

Timeframe: 12 weeks

change of BMI compared to baseline after 12 weeks of stimulation

Timeframe: 12 weeks

the duration of abstinence in gambling disorder

Timeframe: within 24 weeks

change of AuBC score compared to baseline after 12 weeks of stimulation

Timeframe: 12 weeks