Trial Outcomes & Findings for Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study (NCT NCT03680781)
NCT ID: NCT03680781
Last Updated: 2026-04-21
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)
2026-04-21
Participant Flow
Participant milestones
| Measure |
Accelerated Theta Burst Treatment - Left DLPFC
Participants receive intermittent theta-burst stimulation (iTBS) to the left DLPFC 1,800 pulses per session.
|
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.
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
|
Overall Study
STARTED
|
40
|
0
|
|
Overall Study
Participants who dose-escalated
|
0
|
0
|
|
Overall Study
COMPLETED
|
37
|
0
|
Reasons for withdrawal
| Measure |
Accelerated Theta Burst Treatment - Left DLPFC
Participants receive intermittent theta-burst stimulation (iTBS) to the left DLPFC 1,800 pulses per session.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
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=13 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=13 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=13 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 16.12 • n=13 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=13 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=13 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
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
|
|
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
|
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, between the subcallosal cingulate to the default mode network and within the default mode network.
Outcome measures
Outcome data not reported
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