Stereotactic Radiotherapy Treatment for Treatment-resistant Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorCapital Medical University
About this trial
This study is an clinical trial aimed at evaluating the effectiveness and safety of stereotactic radiotherapy for treatment-resistant depression
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
ZAP-X
DeviceThe 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.
Treatment groups
9 Participants
are divided into 3 treatment groupsGroup A: Intervention Group: 15GyExperimental treatment 1 intervention
Group B: Intervention Group: 20GyExperimental treatment 1 intervention
Group C: Intervention Group: 25 GyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre-treatment and 4 weeks post treatmentSecondary outcomes
1
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.
Time frame
Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)2
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.
Time frame
Pre-treatment to post-treatment(week 1, week2, week4, week8, week12)3
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.
Time frame
Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week 8, week12)4
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.
Time frame
Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)Other outcomes
1
Neuroimaging markers at 4/12 week post-treatment compared to baseline
Time frame
4/12 week post-treatment2
Magnetoencephalography (MEG) markers at 1/2/4/8/12week post-treatment compared to baseline
Time frame
Baseline, 1/2/4/8/12 week post-treatment3
Digital phenotype post-treatment compared to baseline
Including Audio and video
Time frame
Pre-treatment to post-treatment(on day 3, week 1, week 2, week 4, week8, week12)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Capital Medical University
Lead sponsor
Chinese PLA General Hospital
Collaborator
Source ClinicalTrials.gov