Back to resultsNeuronavigation Guided iTBS With Personalized Target for Depression
Primary Purpose
Depression
Status
Enrolling by invitation
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
sham iTBS combined with antidepressants
iTBS combined with antidepressants
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring depression, intermittent Theta Burst Stimulation, neuronavigation
Eligibility Criteria
Inclusion Criteria:
- 18 to 60 years old
- Meet the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
- Meet the threshold on the total HAMD17 score of >17 at both screening and baseline visits
- Able to provide informed consent
Exclusion Criteria:
- any other current or past psychiatric axis-I or axis-II disorders
- severe physical illnesses
- psychotic symptoms, alcohol or drug abuse
- A history of neurological disorders including seizure, cerebral trauma
- MRI evidence of structural brain abnormalities
- Contraindications to MRI and rTMS
- Acute suicide
- Female that is pregnant or breastfeeding
Sites / Locations
- XijingH
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
functional MRI-guided iTBS(sham group)
functional MRI-guided iTBS (pgACC-DLPFC)
Arm Description
The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6).
The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6).
Outcomes
Primary Outcome Measures
Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score from Baseline to 4 weeks post treatment
The HAMD-17 total score comprises a sum of the 17 individual item scores. Each item is rated on a 3 points scale from 0 to 2. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression.
Secondary Outcome Measures
Therapeutic response rate and remission rate
Response is defined as a reduction ≥ 50% on the HAMD-17 and remission is defined as a score <8 on the HAMD-17.
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
MADRS total score comprises a sum of the 10 individual item scores. Each item is rated on a 7 point scale from 0 to 6. The Total Score can range from 0 to 60, and higher scores indicate a greater degree of depression.
Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score
BSI-CV is a self-reported questionnaire with 19 items. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total score Scores of 0 - 16 indicate low risk for suicide and scores of 16 or greater indicate higher risk for suicide.
Change in the Hamilton Anxiety Scale (HAMA) Score
HAMD total score comprises a sum of the 14 individual item scores. Each item is rated on a 5 point scale from 0 to 4. The Total Score can range from 0 to 56, and higher scores indicate a greater degree of anxiety.
Change From Baseline Functional Connectivity to Immediately Post-treatment
The change in resting state fMRI functional connectivity of the pgACC, NAc to the default mode network and within the default mode network will be assessed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05577481
Brief Title
Neuronavigation Guided iTBS With Personalized Target for Depression
Official Title
Research on the Efficacy and Brain Network Mechanism of Personalized Targeting Intermittent Theta Burst Stimulation (iTBS) Based on Functional Magnetic Resonance Imaging for the Treatment of Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study will compare the efficacy of intermittent Theta Burst Stimulation (iTBS) with DLPFC-pgACC personalized target for major depressive disorder (MDD) and explore possible brain network mechanisms. The stimulated targets will be located by magnetic resonance imaging (MRI) based on functional MRI based on functional connectivity respectively. This study aims to identify that functional connectivity targeted iTBS protocols on DLPFC-pgACC personalized target have a better antidepressant efficacy compared the sham group and certify that pgACC is an effective potential effector target.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, intermittent Theta Burst Stimulation, neuronavigation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
functional MRI-guided iTBS(sham group)
Arm Type
Sham Comparator
Arm Description
The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6).
Arm Title
functional MRI-guided iTBS (pgACC-DLPFC)
Arm Type
Experimental
Arm Description
The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6).
Intervention Type
Combination Product
Intervention Name(s)
sham iTBS combined with antidepressants
Intervention Description
Two sessions of sham prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
Intervention Type
Combination Product
Intervention Name(s)
iTBS combined with antidepressants
Intervention Description
Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
Primary Outcome Measure Information:
Title
Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score from Baseline to 4 weeks post treatment
Description
The HAMD-17 total score comprises a sum of the 17 individual item scores. Each item is rated on a 3 points scale from 0 to 2. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression.
Time Frame
baseline and 4-week post treatment
Secondary Outcome Measure Information:
Title
Therapeutic response rate and remission rate
Description
Response is defined as a reduction ≥ 50% on the HAMD-17 and remission is defined as a score <8 on the HAMD-17.
Time Frame
immediately post-treatment
Title
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
Description
MADRS total score comprises a sum of the 10 individual item scores. Each item is rated on a 7 point scale from 0 to 6. The Total Score can range from 0 to 60, and higher scores indicate a greater degree of depression.
Time Frame
baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
Title
Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score
Description
BSI-CV is a self-reported questionnaire with 19 items. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total score Scores of 0 - 16 indicate low risk for suicide and scores of 16 or greater indicate higher risk for suicide.
Time Frame
baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
Title
Change in the Hamilton Anxiety Scale (HAMA) Score
Description
HAMD total score comprises a sum of the 14 individual item scores. Each item is rated on a 5 point scale from 0 to 4. The Total Score can range from 0 to 56, and higher scores indicate a greater degree of anxiety.
Time Frame
baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
Title
Change From Baseline Functional Connectivity to Immediately Post-treatment
Description
The change in resting state fMRI functional connectivity of the pgACC, NAc to the default mode network and within the default mode network will be assessed.
Time Frame
baseline and immediately post treatment
Other Pre-specified Outcome Measures:
Title
Change in a Neuropsychological Test Battery from Baseline to immediately post-treatment
Description
The Perceived Deficits Questionnaire - Depression (PDQ-D) is a brief patient-rated scale to assess subjective cognitive dysfunction in people with depression. The PDQ-D is a 20-item questionnaire and the total score ranger from 0 to 80, and higher scores indicate a greater degree of cognitive impairment. THINC-it® is a brief screening tool designed to measure cognition and determine whether cognitive functioning is impaired. Users can complete the cognitive screening in only 10-15 minutes. THINC-it® includes 4 objective cognitive tests (adapted from choice reaction time, 1-back working memory task, symbol digit coding, and Trails-B) and a subjective cognitive questionnaire (PDQ-5).
Time Frame
Pre-treatment to immediately post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 60 years old
Meet the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
Meet the threshold on the total HAMD17 score of >17 at both screening and baseline visits
Able to provide informed consent
Exclusion Criteria:
any other current or past psychiatric axis-I or axis-II disorders
severe physical illnesses
psychotic symptoms, alcohol or drug abuse
A history of neurological disorders including seizure, cerebral trauma
MRI evidence of structural brain abnormalities
Contraindications to MRI and rTMS
Acute suicide
Female that is pregnant or breastfeeding
Facility Information:
Facility Name
XijingH
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
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Neuronavigation Guided iTBS With Personalized Target for Depression
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