Clinical trial NCT05577481: 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
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Depression
Keywords: depression
intermittent Theta Burst Stimulation
neuronavigation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score from Baseline to 4 weeks post treatment
timeFrame: baseline and 4-week post treatment
Secondary outcomes:
measure: Therapeutic response rate and remission rate
timeFrame: immediately post-treatment
measure: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
timeFrame: baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
measure: Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score
timeFrame: baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
measure: Change in the Hamilton Anxiety Scale (HAMA) Score
timeFrame: baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
measure: Change From Baseline Functional Connectivity to Immediately Post-treatment
timeFrame: baseline、immediately post treatment and 4-week post-treatment
Other outcomes:
measure: Change in a Neuropsychological Test Battery from Baseline to immediately post-treatment
timeFrame: Pre-treatment to immediately post-treatment
Locations:
city: Xi'an
country: China
facility: XijingH
state: Shaanxi
Study officials:
References: