Neuronavigation Guided iTBS With Personalized Target for Depression

Depression Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05577481
• Other study ID #: XJLL-KY20222111
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: July 10, 2023
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 68
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Combination Product:
• sham iTBS combined with antidepressants
Two sessions of sham prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
• iTBS combined with antidepressants
Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.

Locations

Country	Name	City	State
China	XijingH	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in a Neuropsychological Test Battery from Baseline to immediately post-treatment	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).	Pre-treatment to immediately post-treatment
Primary	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.	baseline and 4-week post treatment
Secondary	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.	immediately post-treatment
Secondary	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.	baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
Secondary	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.	baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
Secondary	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.	baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
Secondary	Change From Baseline Functional Connectivity to Immediately Post-treatment	The change in resting state fMRI functional connectivity of the pgACC to the default mode network and within the default mode network will be assessed.	baseline?immediately post treatment and 4-week post-treatment