Skip to content

Efficacy and mechanism of implantable neurostimulation system in the treatment of treatment-resistant depression

Efficacy and mechanism of implantable neurostimulation system in the treatment of treatment-resistant depression

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058844
Enrollment
Unknown
Registered
2022-04-17
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Treatment-resistant depression

Interventions

Therapy Group:Implantable deep brain stimulation system

Sponsors

The Affiliated Brain Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of "major depressive Disorder" in DSM-V; 2. Male and female, aged between 18 and 65, with stable vital signs; 3. Duration of current depressive episodes >=2 years, or recurrent episodes, number of episodes >=4 times (duration of current episodes >=1 year); 4. Refractory depression, at least 3 full treatment courses failed, including at least 2 different mechanisms of action of antidepressant drugs (SSRIs, SNRIs, NaSSAs, TCAs) full treatment courses (more than 8 weeks); Refusal, intolerance or poor response to non-convulsive electroconvulsive therapy; 5. Severity of symptoms: HAMD-17>=17 points; 6. In the last month, the antidepressant treatment regimen was stable; 7. Ability and willingness to provide written informed consent; 8. The patient has good compliance and can cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. Schizophrenia or other psychotic symptoms; 2. Severe personality disorder; 3. History of severe neurological disorders such as seizures or cerebral hemorrhage or stroke; 4. Abnormal brain structure; 5. Previous history of stereotactic surgery; 6. Contraindications for general anesthesia or stereotactic neurosurgery; 7. Any circumstances (family support, medical psychosocial or geographical factors) that may now or in the future endanger the patient's safety or prevent the patient from successfully participating in the study.

Design outcomes

Primary

MeasureTime frame
Subtraction rate of Hamilton scale;

Countries

China

Contacts

Public ContactYuping Ning

The Affiliated Brain Hospital of Guangzhou Medical University

ningjeny@126.com+86 020-81570720

Outcome results

None listed

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