Trial Outcomes & Findings for Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study (NCT NCT03680781)
NCT ID: NCT03680781
Last Updated: 2026-07-22
Results Overview
A 21 item clinical assessment tool used to rate a patient's level of depression. The total scores range from 0 to 63 with higher scores indicating worse depression.
COMPLETED
NA
40 participants
Difference between baseline and follow up at one month after the final aiTBS treatment (on day 5)
2026-07-22
Participant Flow
Participant milestones
| Measure |
Accelerated Theta Burst Treatment - Bilateral DLPFC
Participants will receive bilateral iTBS (to the left DLPFC and right DLPFC), with option to dose escalate from 600 to 1800 pulses per session.
|
Accelerated Theta Burst Treatment - Left DLPFC
Participants receive intermittent theta-burst stimulation (iTBS) to the left DLPFC 1,800 pulses per session.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
40
|
|
Overall Study
Participants who dose-escalated
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Accelerated Theta Burst Treatment - Bilateral DLPFC
Participants will receive bilateral iTBS (to the left DLPFC and right DLPFC), with option to dose escalate from 600 to 1800 pulses per session.
|
Accelerated Theta Burst Treatment - Left DLPFC
Participants receive intermittent theta-burst stimulation (iTBS) to the left DLPFC 1,800 pulses per session.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study
Baseline characteristics by cohort
| Measure |
Accelerated Theta Burst Treatment - Left DLPFC
n=37 Participants
Participants receive iTBS to the left DLPFC 1,800 pulses per session.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=9 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 16.12 • n=9 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Difference between baseline and follow up at one month after the final aiTBS treatment (on day 5)Population: Participants with available data at the respective time point
A 21 item clinical assessment tool used to rate a patient's level of depression. The total scores range from 0 to 63 with higher scores indicating worse depression.
Outcome measures
| Measure |
Accelerated Theta Burst Treatment - Left DLPFC
n=36 Participants
Participants receive iTBS to the left DLPFC 1,800 pulses per session.
|
|---|---|
|
Change in Hamilton Depression Rating Scale 21-Item Score
Baseline
|
23.51 score on a scale
Standard Deviation 5.61
|
|
Change in Hamilton Depression Rating Scale 21-Item Score
one month after aiTBS treatment
|
9.44 score on a scale
Standard Deviation 8.79
|
SECONDARY outcome
Timeframe: Baseline, immediately post treatment, 2 weeks post treatment, 4 weeks post treatmentPopulation: Participants with available data at the respective time point
The HAMD-17 is a 17-item rating scale questionnaire administered by clinicians to rate a patient's level of depression . The total scores range from 0 to 52 with higher scores indicating worse depression.
Outcome measures
| Measure |
Accelerated Theta Burst Treatment - Left DLPFC
n=37 Participants
Participants receive iTBS to the left DLPFC 1,800 pulses per session.
|
|---|---|
|
Change in Hamilton Rating Scale for Depression (HAMD-17)
Baseline
|
22.46 score on a scale
Standard Deviation 5.52
|
|
Change in Hamilton Rating Scale for Depression (HAMD-17)
Immediate Post-Treatment
|
8.04 score on a scale
Standard Deviation 6.96
|
|
Change in Hamilton Rating Scale for Depression (HAMD-17)
2 Weeks Post Treatment
|
6.58 score on a scale
Standard Deviation 6.84
|
|
Change in Hamilton Rating Scale for Depression (HAMD-17)
4 Weeks Post Treatment
|
8.94 score on a scale
Standard Deviation 8.42
|
SECONDARY outcome
Timeframe: Baseline, immediately post treatment, 2 weeks post treatment, 4 weeks post treatmentPopulation: Participants with available data at the respective time point
A rating scale that measures the current intensity of specific attitudes, behaviors, and plans to commit suicide. The total scores range from 0 to 38 with higher scores indicating greater suicidality.
Outcome measures
| Measure |
Accelerated Theta Burst Treatment - Left DLPFC
n=34 Participants
Participants receive iTBS to the left DLPFC 1,800 pulses per session.
|
|---|---|
|
Change in The Scale for Suicide Ideation
Baseline
|
3.88 score on a scale
Standard Deviation 5.22
|
|
Change in The Scale for Suicide Ideation
Immediate Post Treatment
|
1.46 score on a scale
Standard Deviation 2.80
|
|
Change in The Scale for Suicide Ideation
2 Weeks Post Treatment
|
0.77 score on a scale
Standard Deviation 1.36
|
|
Change in The Scale for Suicide Ideation
4 Weeks Post Treatment
|
0.38 score on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Every day of stimulation on days (visits) 1, 2, 3, 4, and 5Population: Participants with available data at the respective time point
The HAMD-6 is a shorter, six-item version of the Hamilton Depression Rating Scale (HAMD-D) that measures core symptoms of major depressive disorder, such as depressed mood, guilt and anxiety. The total scores range from 0 to 22 with higher scores indicating worse depression.
Outcome measures
| Measure |
Accelerated Theta Burst Treatment - Left DLPFC
n=22 Participants
Participants receive iTBS to the left DLPFC 1,800 pulses per session.
|
|---|---|
|
Change in Hamilton Rating Scale for Depression (HAMD-6)
Day 1 (Visit 1)
|
12.29 score on a scale
Standard Deviation 3.38
|
|
Change in Hamilton Rating Scale for Depression (HAMD-6)
Day 2 (Visit 2)
|
9.48 score on a scale
Standard Deviation 4.61
|
|
Change in Hamilton Rating Scale for Depression (HAMD-6)
Day 3 (Visit 3)
|
8.20 score on a scale
Standard Deviation 4.97
|
|
Change in Hamilton Rating Scale for Depression (HAMD-6)
Day 4 (Visit 4)
|
7.50 score on a scale
Standard Deviation 5.03
|
|
Change in Hamilton Rating Scale for Depression (HAMD-6)
Day 5 (Visit 5)
|
5.68 score on a scale
Standard Deviation 4.59
|
SECONDARY outcome
Timeframe: Baseline, immediately post-treatment, 4 weeks post-treatmentWe will assess functional connectivity as seen on resting state fMRI within the default mode network.
Outcome measures
| Measure |
Accelerated Theta Burst Treatment - Left DLPFC
n=17 Participants
Participants receive iTBS to the left DLPFC 1,800 pulses per session.
|
|---|---|
|
Change From Baseline Functional Connectivity Within the Default Mode Network.
Baseline
|
0.07908836 Spearman Correlation Coefficient
Standard Deviation 0.02426973
|
|
Change From Baseline Functional Connectivity Within the Default Mode Network.
Immediate Post-Treatment
|
0.07140352 Spearman Correlation Coefficient
Standard Deviation 0.02413489
|
|
Change From Baseline Functional Connectivity Within the Default Mode Network.
4 Weeks Post Treatment
|
0.072705 Spearman Correlation Coefficient
Standard Deviation 0.03303109
|
SECONDARY outcome
Timeframe: Baseline, immediately post-treatment, 4 weeks post-treatmentWe will assess functional connectivity as seen on resting state fMRI of subcallosal cingulate cortex to the default mode network.
Outcome measures
| Measure |
Accelerated Theta Burst Treatment - Left DLPFC
n=18 Participants
Participants receive iTBS to the left DLPFC 1,800 pulses per session.
|
|---|---|
|
Change From Baseline Functional Connectivity of Subcallosal Cingulate Cortex and the Default Mode Network.
Baseline
|
0.01693136 Spearman Correlation Coefficient
Standard Deviation 0.01300536
|
|
Change From Baseline Functional Connectivity of Subcallosal Cingulate Cortex and the Default Mode Network.
Immediate Post-Treatment
|
0.01460948 Spearman Correlation Coefficient
Standard Deviation 0.01204029
|
|
Change From Baseline Functional Connectivity of Subcallosal Cingulate Cortex and the Default Mode Network.
4 Weeks Post-Treatment
|
0.01199477 Spearman Correlation Coefficient
Standard Deviation 0.0158596
|
SECONDARY outcome
Timeframe: Baseline, immediately post-treatment, 4 weeks post-treatmentPopulation: Participants with available data at the respective time point
The Beck Depression Inventory (BDI) is a 21-item self-report questionnaire used to measure the severity of depression symptoms. The total scores range from 0 to 63 with higher scores indicating worse depression.
Outcome measures
| Measure |
Accelerated Theta Burst Treatment - Left DLPFC
n=23 Participants
Participants receive iTBS to the left DLPFC 1,800 pulses per session.
|
|---|---|
|
Change in Beck Depression Inventory (BDI)
Baseline
|
27.43 score on a scale
Standard Deviation 9.40
|
|
Change in Beck Depression Inventory (BDI)
Immediately Post Treatment
|
11.39 score on a scale
Standard Deviation 11.12
|
|
Change in Beck Depression Inventory (BDI)
4 Weeks Post Treatment
|
10.15 score on a scale
Standard Deviation 9.29
|
SECONDARY outcome
Timeframe: Baseline, immediate post-treatment, 4 weeks post-treatmentPopulation: Participants with available data at the respective time point
The MADRS (Montgomery-Åsberg Depression Rating Scale) is a 10-item diagnostic tool used by clinicians to assess the severity of depression by scoring symptoms on a 0-60 scale with higher scores indicating worse depression.
Outcome measures
| Measure |
Accelerated Theta Burst Treatment - Left DLPFC
n=37 Participants
Participants receive iTBS to the left DLPFC 1,800 pulses per session.
|
|---|---|
|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
Baseline
|
30.54 score on a scale
Standard Deviation 7.68
|
|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
Immediate Post Treatment
|
10.72 score on a scale
Standard Deviation 10.85
|
|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
4 weeks post treatment
|
12.65 score on a scale
Standard Deviation 11.51
|
Adverse Events
Accelerated Theta Burst Treatment - Left DLPFC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place