Actively Recruiting
The Efficacy and Safety of Stereotactic Radiotherapy for Treatment-Resistant Depression: An Open-Label Exploratory Study
Led by Capital Medical University · Updated on 2026-04-27
9
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Capital Medical University
Lead Sponsor
C
Chinese PLA General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Treatment-Resistant Depression (TRD) affects patients who have not improved after trying at least two different antidepressants at adequate doses and durations. TRD often leads to poor outcomes and disrupts daily life for patients and their families. This trial investigates the use of stereotactic radiotherapy, a targeted radiation technique, to safely regulate brain function in the subgenual anterior cingulate cortex (sgACC) area associated with TRD, aiming to explore the safety, effectiveness, and biological effects of this approach. Participants will receive stereotactic radiotherapy using the ZAP-X device, which plans treatment based on detailed MRI imaging of the brain. Patients are randomized to receive one of three doses—15 Gy, 20 Gy, or 25 Gy—delivered as unilateral irradiation once daily over two consecutive days. Before treatment, patients undergo 3 to 7 MRI scans spaced at least 24 hours apart to identify precise target areas, which are manually adjusted to avoid brain blood vessels. During the study, participants will have multiple assessments including depression rating scales, suicide severity scales, mood and anxiety measures, and cognitive tests at various time points before and after treatment. The primary measure is the change in depression severity four weeks after treatment. Safety and efficacy will be monitored throughout the study, with follow-up visits up to 12 weeks post-treatment. Total participation duration covers preparation, treatment, and multiple follow-up evaluations.
CONDITIONS
Brief Title
Stereotactic Radiotherapy Treatment for Treatment-resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients or inpatients aged 18 to 50 years, any gender
- Diagnosed with Major Depressive Disorder, recurrent, without psychotic features according to DSM-5
- Documented treatment-resistant depression with less than 50% improvement after at least two adequate antidepressant trials in the current episode
- Hamilton Depression Rating Scale (HAMD-17) score of 20 or higher at screening and baseline
- Agree to keep current antidepressant treatment unchanged during the study
- Able to understand the study and provide written informed consent
You will not qualify if you...
- Diagnosis of any other DSM-5 mental disorder such as bipolar disorder, schizophrenia, or personality disorders
- Significant unstable medical conditions including cardiovascular, respiratory, digestive, endocrine, urinary, hematological, nervous system diseases, or tumors
- Severe neurological diseases or impairments including brain lesions, stroke, epilepsy, cerebral aneurysm, Parkinson's, Huntington's, multiple sclerosis, or severe head trauma
- High suicide risk based on recent suicidal ideation or behavior assessments
- Use of neuromodulation therapies like MECT, rTMS, tDCS, VNS, or DBS within 3 months or recent participation in other clinical trials
- History of non-response to MECT treatment
- Previous psychosurgical procedures or prior radiotherapy, chemotherapy, or occupational radiation exposure
- Contraindications to MRI such as metallic implants or claustrophobia
- Pregnant or breastfeeding women, or planning pregnancy within 6 months without contraception
- Body weight over 150 kg
- Any other condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
3 to 7 MRI scans during baseline preparation with at least 24 hours between scans
Duration - 2 days
Participants receive stereotactic radiotherapy targeting the subgenual anterior cingulate cortex (sgACC) over two consecutive days, with each session lasting approximately 20 minutes.
2 treatment sessions (in-person)
Duration - 12 weeks
Participants are assessed for changes in depression symptoms and other clinical measures over 12 weeks after treatment.
Visits on day 3, week 1, week 2, week 4, week 8, and week 12 post-treatment
Trial Site Locations
Total: 1 location
1
Beijing Anding Hospital, Capital Medical University
Beijing, China
Actively Recruiting
Research Team
A
Aihong Yu, Prof., Medical Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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