Treatment-Resistant DepressionNCT07274917
Stereotactic Radiotherapy Treatment for Treatment-Resistant Depression
A study testing ZAP-X in people with Treatment-Resistant Depression and Depressive Disorder, run by Capital Medical University at 1 site in China.
Trial summary
This study is an clinical trial aimed at evaluating the effectiveness and safety of stereotactic radiotherapy for treatment-resistant depression Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Treatment-Resistant Depression, Depressive Disorder
- What is being tested?
- ZAP-X
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Outpatients or inpatients aged 18 to 50 years (inclusive), regardless of gender.
- Meet the diagnostic criteria for Major Depressive Disorder (MDD), recurrent, without psychotic features, as defined by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Documented treatment-resistant depression, defined as a lack of clinically meaningful response (less than 50% improvement in depressive symptoms) to at least two adequate antidepressant trials during the current episode, as recorded by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ). An adequate trial requires sufficient dosage (within the recommended therapeutic range) and duration (at least 6 weeks). The current episode must involve at least one treatment failure.
- A Hamilton Depression Rating Scale 17-item (HAMD-17) total score of ≥ 20 at both the screening and baseline visits.
- The subject agrees to maintain their existing baseline antidepressant therapy regimen unchanged throughout the study period.
- The patient and their legal guardian understand and voluntarily agree to participate in this study, are capable of adhering to the treatment protocol, and provide written informed consent.
Who cannot join
- A current or prior diagnosis of any other DSM-5 mental disorder, including but not limited to: neurodevelopmental disorders, bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, substance-related and addictive disorders, or personality disorders.
- A past medical history or current presence of clinically significant somatic diseases, such as severe or unstable cardiovascular, respiratory, digestive, endocrine, urinary, hematological, or nervous system diseases, or benign/malignant tumors; or any condition deemed by the investigator to pose a potential risk to patient safety or their ability to fully participate in the study.
- Any severe neurological disease or impairment, including but not limited to: any condition potentially associated with increased intracranial pressure, space-occupying brain lesions, cerebral infarction, intracranial hemorrhage, history of epileptic seizures or family history of epilepsy (except for those induced by ECT), cerebral aneurysm, Parkinson's disease, Huntington's disease, multiple sclerosis, or a history of severe head trauma with loss of consciousness; or any condition deemed by the investigator to pose a potential risk to patient safety or their ability to fully participate in the study.
- Assessed by the investigator as being at significant risk of suicide, evidenced by: a "Yes" response to Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) in the "Suicidal Ideation" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 6 months; OR a "Yes" response to any item in the "Suicidal Behavior" section of the C-SSRS (actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior) within the past 6 months; OR a score of ≥5 on Item 10 (Suicidal Thoughts) of the Montgomery-Åsberg Depression Rating Scale (MADRS).
- Participation in other systematic neuromodulation therapies (e.g., MECT, rTMS, tDCS, VNS, DBS) within 3 months prior to screening, or participation in an interventional clinical trial within 1 month prior to screening.
- Patients who have been non-responsive to a systematic course of MECT treatment.
Show all 13Show fewer
- Patients with a history of other psychosurgical procedures (including radiofrequency ablation, focused ultrasound, etc.).
- A history of prior radiotherapy, chemotherapy, or immunotherapy, or a history of occupational exposure to radiation/toxic substances.
- Contraindications to Magnetic Resonance Imaging (MRI), including but not limited to: intracranial or bodily metallic implants, implanted pacemakers or cochlear implants, or claustrophobia.
- Pregnant or lactating women.
- Subjects of either gender who plan to become pregnant within the next 6 months or are unwilling to use effective contraception.
- Subjects with a body weight exceeding 150 kg.
- Any other condition considered by the investigator to make the subject unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Low-Dose Stereotactic Radiotherapy Targeting the Subgenual Anterior Cingulate Cortex for Treatment-Resistant Depression: Study Protocol for a Dose-Exploratory, Parallel-Controlled Trial
This study is an clinical trial aimed at evaluating the effectiveness and safety of stereotactic radiotherapy for treatment-resistant depression
Read the detailed description
Treatment-Resistant Depression (TRD) generally refers to patients with depression who have received at least two antidepressants with different mechanisms of action, at adequate doses and for sufficient durations, but have shown poor or no response. TRD is difficult to treat and usually has a poor prognosis, seriously affecting the normal life of patients and their families. One of the imaging manifestations of TRD patients is abnormal functional activity of the subgenual anterior cingulate cortex (sgACC). The direct clinical intervention method for this area is to implant a deep brain stimulator through an invasive approach. However, this intervention method has a low risk-benefit ratio and is poorly accepted by patients.
Radiation is a widely used clinical intervention technique. By focusing rays from multiple angles, it can generate high-energy rays in a local area of the human brain for ablation. This technique is typically used for targeted ablation of tumors and has the advantage of high precision. Recently, breakthrough research has found that radiotherapy can be applied in the field of psychiatry. In experiments with doses of 10Gy and 20Gy, researchers observed an increase in the standard uptake value of the irradiated target area compared to the contralateral brain region in PET images of the subjects, suggesting that radiotherapy can up-regulate glucose metabolism levels without killing neurons at low doses. These clinical studies suggest that stereotactic radiotherapy can safely regulate brain function. Based on this, this project aims to explore the safety, efficacy, and biological mechanisms of low-dose radiotherapy targeting the sgACC in the treatment of TRD.
- Being tested
- ZAP-X
- Keywords
- Treatment-Resistant depression, X-ray, subgenual anterior cingulate cortex, ZAP-X, stereotactic radiotherapy
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZAP-XDevice
The individualized bilateral sgACC template will be imported into the ZAP-X treatment planning system. For left and right sgACC targets, the treatment plan will be automatically generated with the following set-up. The treatment will be carried out on two consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: 15Gy | Experimental | All patients will then undergo 3 (minimum)-7 (maximum) MRI scans during baseline preparation period, with intervals of more than 24 hours between scans. Based on the axial enhanced 3D T1-weighted MRI image, the anterior commissure (AC) and posterior commissure (PC) are determined. Select the sagittal T1 image and identify the cingulate sulcus below the genu of the corpus callosum. Draw a line from the genu of the corpus callosum to the anterior commissure and take the midpoint. Then, on the coronal T1 image, locate the coronal section corresponding to this midpoint as the target point. The target point will be adjusted manually to avoid overlapping with brain blood vessels, The treatment schedule was as follows: each patient received unilateral irradiation per day at a dose of 15 Gy, with each session lasting approximately 20 minutes. The entire treatment was completed over two days, and the isodose lines were set at 80% Receives: Device: ZAP-X |
| Intervention Group: 20Gy | Experimental | All patients will then undergo 3 (minimum)-7 (maximum) MRI scans during baseline preparation period, with intervals of more than 24 hours between scans. Based on the axial enhanced 3D T1-weighted MRI image, the anterior commissure (AC) and posterior commissure (PC) are determined. Select the sagittal T1 image and identify the cingulate sulcus below the genu of the corpus callosum. Draw a line from the genu of the corpus callosum to the anterior commissure and take the midpoint. Then, on the coronal T1 image, locate the coronal section corresponding to this midpoint as the target point. The target point will be adjusted manually to avoid overlapping with brain blood vessels, The treatment schedule was as follows: each patient received unilateral irradiation per day at a dose of 20 Gy, with each session lasting approximately 20 minutes. The entire treatment was completed over two days, and the isodose lines were set at 80% Receives: Device: ZAP-X |
| Intervention Group: 25 Gy | Experimental | All patients will then undergo 3 (minimum)-7 (maximum) MRI scans during baseline preparation period, with intervals of more than 24 hours between scans. Based on the axial enhanced 3D T1-weighted MRI image, the anterior commissure (AC) and posterior commissure (PC) are determined. Select the sagittal T1 image and identify the cingulate sulcus below the genu of the corpus callosum. Draw a line from the genu of the corpus callosum to the anterior commissure and take the midpoint. Then, on the coronal T1 image, locate the coronal section corresponding to this midpoint as the target point. The target point will be adjusted manually to avoid overlapping with brain blood vessels, The treatment schedule was as follows: each patient received unilateral irradiation per day at a dose of 25 Gy, with each session lasting approximately 20 minutes. The entire treatment was completed over two days, and the isodose lines were set at 80% Receives: Device: ZAP-X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score at 4 weeks post-treatment compared to baseline
A ten item questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.
Measured: Pre-treatment and 4 weeks post treatment
Secondary outcomes (10)
Change in the Montgomery Asberg Depression Rating Scale (MADRS)
A ten item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.
Measured: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Change in Columbia Suicide Severity Rating Scale (C-SSRS) score post-treatment
A suicidal ideation rating scale created by researchers at Columbia University. The score was calculated by summing the answers to 5 questions. Score range - 0 to 5. Higher score indicate higher suicidal ideation.
Measured: Pre-treatment to post-treatment(week 1, week2, week4, week8, week12)
Change in Quick Inventory of Depressive Symptomatology (QIDS-SR-16) score post-treatment
The QIDS-SR16 consists of 16 items, with each item ranging between 0 and 3 points. The total score ranged from 0 to 27 with higher score implicated severe depressive symptoms.
Measured: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week 8, week12)
Change in clinical global impression-severity(CGI-S) post-treatment
The Clinical Global Impression - Severity (CGI-S) is a single-item, clinician-rated scale used to assess the overall severity of a patient's illness. The rating is based on the clinician's total experience with this patient population. It is scored on a 7-point scale, ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients), with higher scores indicating greater illness severity.
Measured: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Change in clinical global impression-improvement(CGI-I) post-treatment
The Clinical Global Impression - Improvement (CGI-I) is a single-item, clinician-rated scale used to assess how much a patient's illness has improved or worsened since the start of treatment. It is scored on a 7-point scale, ranging from 1 (Very much improved) to 7 (Very much worse), with a score of 4 representing "No change". The rating is based on the clinician's assessment of the patient's overall clinical state.
Measured: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Change in Instant Mood Scale-12 post-treatment
The Instant Mood Scale-12 (IMS-12) is a brief, 12-item self-report questionnaire designed to rapidly assess the current severity of depression and anxiety symptoms.Each item is rated on a 7-point Likert scale (0="Not at all" to 7="Extremely") based on the patient's feelings at the present moment. Total scores for each subscale range from 0 to 84, with higher scores indicating greater symptom severity.
Measured: Pre-treatment to immediate during treatment(on day 1, day 2) and post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Change in Hamilton Anxiety Scale(HAMA) post-treatment
A 14-item, clinician-administered scale designed to assess the severity of a patient's anxiety. Scores range from 0-56, with higher scores reflecting greater anxiety severity.
Measured: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Change in Digital Span Test score post-treatment
A test of working memory and attention where participants repeat sequences of auditorily presented numbers, both in forward and backward order. The primary outcome is the longest sequence correctly recalled.
Measured: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Change in Digit Symbol Substitution Test post-treatment
The Digit Symbol Substitution Test (DSST) is a performance-based neuropsychological test that assesses processing speed, sustained attention, and visual-motor coordination. The test presents the participant with a key pairing nine numbers (1-9) with nine unique symbols. The main task requires the participant to fill in blank spaces with the corresponding symbol for a series of randomly ordered numbers as quickly and accurately as possible within 90 seconds. The primary score is the total number of correct symbol substitutions completed within the time allowed.
Measured: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Change in Perceived Deficits Questionnaire - Depression score post-treatment
The Perceived Deficits Questionnaire - Depression (PDQ-D) is a 20-item self-report scale designed to measure a patient's subjective experience of cognitive dysfunction. It assesses perceived difficulties in four key cognitive domains: attention/concentration (5 items), retrospective memory (5 items), prospective memory (5 items), and planning/organization (5 items). Patients rate the frequency of these cognitive problems over the past week on a 5-point scale from 0 ("Never") to 4 ("Almost always"). A total score is calculated (range 0-80), with higher scores indicating greater perceived cognitive deficits.
Measured: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start26 Jan 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Principal investigator, Gang Wang, Capital Medical University
- Investigators
- Gang Wang, Medical Doctor, Principal investigator, Beijing Anding Hospital, Capital Medical UniversityLongsheng Pan, Medical Doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274917
- Sponsor's protocol ID
- 2025(60)
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Low-Dose Stereotactic Radiotherapy Targeting the Subgenual Anterior Cingulate Cortex for Treatment-Resistant Depression: Study Protocol for a Dose-Exploratory, Parallel-Controlled Trial
- ClinicalTrials.gov ID
- NCT07274917
- Acronym / sponsor ID
- 2025(60)
- Keywords
- Treatment-Resistant depression, X-ray, subgenual anterior cingulate cortex, ZAP-X, stereotactic radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an clinical trial aimed at evaluating the effectiveness and safety of stereotactic radiotherapy for treatment-resistant depression
Detailed description
Treatment-Resistant Depression (TRD) generally refers to patients with depression who have received at least two antidepressants with different mechanisms of action, at adequate doses and for sufficient durations, but have shown poor or no response. TRD is difficult to treat and usually has a poor prognosis, seriously affecting the normal life of patients and their families. One of the imaging manifestations of TRD patients is abnormal functional activity of the subgenual anterior cingulate cortex (sgACC). The direct clinical intervention method for this area is to implant a deep brain stimulator through an invasive approach. However, this intervention method has a low risk-benefit ratio and is poorly accepted by patients.
Radiation is a widely used clinical intervention technique. By focusing rays from multiple angles, it can generate high-energy rays in a local area of the human brain for ablation. This technique is typically used for targeted ablation of tumors and has the advantage of high precision. Recently, breakthrough research has found that radiotherapy can be applied in the field of psychiatry. In experiments with doses of 10Gy and 20Gy, researchers observed an increase in the standard uptake value of the irradiated target area compared to the contralateral brain region in PET images of the subjects, suggesting that radiotherapy can up-regulate glucose metabolism levels without killing neurons at low doses. These clinical studies suggest that stereotactic radiotherapy can safely regulate brain function. Based on this, this project aims to explore the safety, efficacy, and biological mechanisms of low-dose radiotherapy targeting the sgACC in the treatment of TRD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: 15Gy | Experimental | Device: ZAP-XAll patients will then undergo 3 (minimum)-7 (maximum) MRI scans during baseline preparation period, with intervals of more than 24 hours between scans. Based on the axial enhanced 3D T1-weighted MRI image, the anterior commissure (AC) and posterior commissure (PC) are determined. Select the sagittal T1 image and identify the cingulate sulcus below the genu of the corpus callosum. Draw a line from the genu of the corpus callosum to the anterior commissure and take the midpoint. Then, on the coronal T1 image, locate the coronal section corresponding to this midpoint as the target point. The target point will be adjusted manually to avoid overlapping with brain blood vessels, The treatment schedule was as follows: each patient received unilateral irradiation per day at a dose of 15 Gy, with each session lasting approximately 20 minutes. The entire treatment was completed over two days, and the isodose lines were set at 80% |
| Intervention Group: 20Gy | Experimental | Device: ZAP-XAll patients will then undergo 3 (minimum)-7 (maximum) MRI scans during baseline preparation period, with intervals of more than 24 hours between scans. Based on the axial enhanced 3D T1-weighted MRI image, the anterior commissure (AC) and posterior commissure (PC) are determined. Select the sagittal T1 image and identify the cingulate sulcus below the genu of the corpus callosum. Draw a line from the genu of the corpus callosum to the anterior commissure and take the midpoint. Then, on the coronal T1 image, locate the coronal section corresponding to this midpoint as the target point. The target point will be adjusted manually to avoid overlapping with brain blood vessels, The treatment schedule was as follows: each patient received unilateral irradiation per day at a dose of 20 Gy, with each session lasting approximately 20 minutes. The entire treatment was completed over two days, and the isodose lines were set at 80% |
| Intervention Group: 25 Gy | Experimental | Device: ZAP-XAll patients will then undergo 3 (minimum)-7 (maximum) MRI scans during baseline preparation period, with intervals of more than 24 hours between scans. Based on the axial enhanced 3D T1-weighted MRI image, the anterior commissure (AC) and posterior commissure (PC) are determined. Select the sagittal T1 image and identify the cingulate sulcus below the genu of the corpus callosum. Draw a line from the genu of the corpus callosum to the anterior commissure and take the midpoint. Then, on the coronal T1 image, locate the coronal section corresponding to this midpoint as the target point. The target point will be adjusted manually to avoid overlapping with brain blood vessels, The treatment schedule was as follows: each patient received unilateral irradiation per day at a dose of 25 Gy, with each session lasting approximately 20 minutes. The entire treatment was completed over two days, and the isodose lines were set at 80% |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Outpatients or inpatients aged 18 to 50 years (inclusive), regardless of gender.
- Meet the diagnostic criteria for Major Depressive Disorder (MDD), recurrent, without psychotic features, as defined by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Documented treatment-resistant depression, defined as a lack of clinically meaningful response (less than 50% improvement in depressive symptoms) to at least two adequate antidepressant trials during the current episode, as recorded by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ). An adequate trial requires sufficient dosage (within the recommended therapeutic range) and duration (at least 6 weeks). The current episode must involve at least one treatment failure.
- A Hamilton Depression Rating Scale 17-item (HAMD-17) total score of ≥ 20 at both the screening and baseline visits.
- The subject agrees to maintain their existing baseline antidepressant therapy regimen unchanged throughout the study period.
Key exclusion criteria (13 listed)
- A current or prior diagnosis of any other DSM-5 mental disorder, including but not limited to: neurodevelopmental disorders, bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, substance-related and addictive disorders, or personality disorders.
- A past medical history or current presence of clinically significant somatic diseases, such as severe or unstable cardiovascular, respiratory, digestive, endocrine, urinary, hematological, or nervous system diseases, or benign/malignant tumors; or any condition deemed by the investigator to pose a potential risk to patient safety or their ability to fully participate in the study.
- Any severe neurological disease or impairment, including but not limited to: any condition potentially associated with increased intracranial pressure, space-occupying brain lesions, cerebral infarction, intracranial hemorrhage, history of epileptic seizures or family history of epilepsy (except for those induced by ECT), cerebral aneurysm, Parkinson's disease, Huntington's disease, multiple sclerosis, or a history of severe head trauma with loss of consciousness; or any condition deemed by the investigator to pose a potential risk to patient safety or their ability to fully participate in the study.
- Assessed by the investigator as being at significant risk of suicide, evidenced by: a "Yes" response to Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) in the "Suicidal Ideation" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 6 months; OR a "Yes" response to any item in the "Suicidal Behavior" section of the C-SSRS (actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior) within the past 6 months; OR a score of ≥5 on Item 10 (Suicidal Thoughts) of the Montgomery-Åsberg Depression Rating Scale (MADRS).
- Participation in other systematic neuromodulation therapies (e.g., MECT, rTMS, tDCS, VNS, DBS) within 3 months prior to screening, or participation in an interventional clinical trial within 1 month prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZAP-XThe individualized bilateral sgACC template will be imported into the ZAP-X treatment planning system. For left and right sgACC targets, the treatment plan will be automatically generated with the following set-up. The treatment will be carried out on two consecutive days. | Device | Intervention Group: 15Gy, Intervention Group: 20Gy, Intervention Group: 25 Gy |
Primary outcome
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score at 4 weeks post-treatment compared to baseline
Time frame: Pre-treatment and 4 weeks post treatment
A ten item questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.
10 secondary outcomes
Change in the Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Change in Columbia Suicide Severity Rating Scale (C-SSRS) score post-treatment
Time frame: Pre-treatment to post-treatment(week 1, week2, week4, week8, week12)
Change in Quick Inventory of Depressive Symptomatology (QIDS-SR-16) score post-treatment
Time frame: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week 8, week12)
Change in clinical global impression-severity(CGI-S) post-treatment
Time frame: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Change in clinical global impression-improvement(CGI-I) post-treatment
Time frame: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Change in Instant Mood Scale-12 post-treatment
Time frame: Pre-treatment to immediate during treatment(on day 1, day 2) and post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Change in Hamilton Anxiety Scale(HAMA) post-treatment
Time frame: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Change in Digital Span Test score post-treatment
Time frame: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Change in Digit Symbol Substitution Test post-treatment
Time frame: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Change in Perceived Deficits Questionnaire - Depression score post-treatment
Time frame: Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Wang, Medical Doctor principal investigator
Beijing Anding Hospital, Capital Medical University
Longsheng Pan, Medical Doctor principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZAP-X in people with Treatment-Resistant Depression and Depressive Disorder, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score at 4 weeks post-treatment compared to baseline (time frame: Pre-treatment and 4 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.