Skip to content

Clinical trial for dual-target deep Brain Stimulation in the treatment of refractory depression

Clinical trial for dual-target deep Brain Stimulation in the treatment of refractory depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069983
Enrollment
Unknown
Registered
2023-03-30
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

refractory depression

Interventions

NAc/ALIC-DBS group:Accept bilateral NAc/ALIC-DBS

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Age: 16-65 years old, males or females; 2) All the cases meet the diagnostic criteria of depressive disorder in the diagnostic and Statistical Manual of mental disorders - Fifth Edition (DSM-V); 3) HAMD-24 score >= 17 points; 4) The duration of depression was more than 2 years; or recurrent episodes, with at least 4 episodes (the duration of the current episode is at least 1 year); 5) Two or more antidepressants with different mechanisms were used with adequate dosage and duration (>= 8 weeks), and at least 3 failures with the treatment plan. The patient refused, could not tolerate or did not respond to the treatment of electroconvulsive therapy; 6) During the whole trial, female with fertility must use medically acceptable contraceptive methods; 7) Every patient must be able to communicate fully, both the patient and legal guardian need to sign a written informed consent; 8) All the patients must have received psychological treatment for more than 6 weeks continuously without obvious improvement;

Exclusion criteria

Exclusion criteria: 1) Bipolar disorder, schizophrenic affective disorder, schizophrenia or other psychiatric disorders; 2) Severe personality disorder; 3) Severe physical disease or brain organic disease; 4) Alcohol or drug abuse and dependence were diagnosed according to DSM-IV diagnostic criteria within 1 year before therapy; 5) Patients with surgical contraindications, such as major medical comorbidities or anticoagulants cannot be stopped; 6) Preoperative brain magnetic resonance imaging (MRI) showed obvious structural imaging abnormalities; 7) Contraindication of MRI (excluding DBS electrodes or stimulator to be implanted); 8) Pregnancy or lactation; 9) The patient is participating in another study unrelated to the current study; 10) Any situation (family support; medical, psychological, social or geographical factors) that may endanger the patient's safety or prevent the patient from participating in the study at present or in the future;

Design outcomes

Primary

MeasureTime frame
Hamilton Dpression Scale, HAMD-17;

Secondary

MeasureTime frame
WHOQOL-BREF;Montreal Cognitive Assessment, MoCA;Columbia suicide severity rating scale,CSSRS;

Countries

China

Contacts

Public ContactWang Wei

West China Hospital, Sichuan University

wcnsww@163.com+86 18980601521

Outcome results

None listed

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