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An exploratory clinical study of implantable deep brain stimulation system for treatment-resistant depression

Clinical study on the safety and efficacy of deep brain stimulation for treatment-resistant depression

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045363
Enrollment
Unknown
Registered
2021-04-13
Start date
2021-04-10
Completion date
Unknown
Last updated
2022-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Treatment group:Implantable deep brain stimulation system

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-70 years, regardless of gender; 2.Psychiatrist diagnosed major depressive disorder according to Diagnostic And Statistical Manual Of Mental Disorders. 5th Ed (DSM-V); 3.Psychiatric examination by two trained psychiatrists and diagnosis according to DSM-V, diagnosis consistent; 4.A history of depression lasting at least 24 months, with a reduction rate of = 20; 6.Global Assessment Function(GAF) score <= 50; 7.Patient or legal guardian need fully understand the treatments and sign the informed consent before Adding to the group.

Exclusion criteria

Exclusion criteria: 1.Patients with severe or unstable heart, liver, kidney, endocrine, blood and other internal diseases or comorbidities with psychotic symptoms, including the personality disorders diagnosed during medical history, consultation and clinical examination; 2.Patients with a history of drug abuse within 12 months; A history of epilepsy, or high fever and convulsion in childhood; 3.Subjects who had attempted suicide in the past 6 months or more than 2 suicide attempts in the past 2 years; 4.Women who are breast-feeding, pregnant, and subjects who are pregnant or planning to become pregnant during the clinical study; 5.Patients have contraindications about DBS surgery and chronic irritation; 6.Subjects of involuntary hospitalization.

Design outcomes

Primary

MeasureTime frame
Subtraction rate of Hamilton scale;

Countries

China

Contacts

Public ContactCui Zhiqiang

Chinese PLA General Hospital

zhiqiangcui2008@hotmail.com+86 13811008066

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026