A Single-Center, Prospective, Exploratory Clinical Study on the Efficacy and Mechanisms of Subcallosal Cingulate Deep Brain Stimulation for Difficult-to-Treat Depression

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600122022

Enrollment

Unknown

Registered

2026-04-08

Start date

2026-04-30

Completion date

Unknown

Last updated

2026-04-14

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

Conditions

Depression

Interventions

difficult-to-treat depression group:subcallosal cingulate deep brain stimulation

healthy group:None

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for difficult-to-treat depression (DTD). 2. During the screening period, has a MADRS score >= 20, with no more than a 25% difference between two assessments performed at least 2 weeks apart. 3. Aged 18–65 years (inclusive), with no restriction on sex. 4. Demonstrates good medication adherence, with a stable antidepressant regimen for at least 4 weeks prior to enrollment. 5. No structural brain abnormalities detected on screening neuroimaging. 6. Willing and able to comply with multimodal neuroimaging and electrophysiological assessments throughout the study period. 7. Provides written informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Does not meet the diagnostic criteria for difficult-to-treat depression (DTD). 2. Current or lifetime diagnosis of bipolar disorder, schizophrenia, obsessive–compulsive disorder, anxiety disorder (HAMA score >= 21 at screening and/or at randomization), post-traumatic stress disorder, dementia, or other neurocognitive disorders. 3. Intracranial space-occupying lesions, extensive white matter changes, or other severe structural abnormalities identified on screening neuroimaging. 4. High suicide risk, defined as a clear suicide attempt or suicidal behavior, or a MADRS item 10 (suicidal thoughts) score >= 4. 5. Receipt of investigational agents or participation in another clinical trial within the past 3 months that could confound study outcomes. 6. Pregnancy or lactation, or women of childbearing potential who are planning pregnancy. 7. History of substance misuse, including alcohol dependence with clinically significant withdrawal symptoms.

Design outcomes

Primary

Measure	Time frame
Montgomery–?sberg Depression Rating Scale;Hamilton Depression Rating Scale;Zung Self-Rating Depression Scale;	—

Secondary

Measure	Time frame
Clinical Global Impressions;Hamilton Anxiety Rating Scale;Montreal Cognitive Assessment;MADRS Item 10 – Suicidal Thoughts (MADRS Item 10);36-Item Short Form Health Survey;	—

Countries

China

Contacts

Public ContactZhang Yuqi

Tsinghua University Yuquan Hospital

yuqi9597@sina.com+86 133 1133 0912

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026