Trial Outcomes & Findings for Personalized Therapeutic Neuromodulation for Anhedonic Depression (NCT NCT05144789)
NCT ID: NCT05144789
Last Updated: 2026-07-29
Results Overview
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item self-survey administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Score range: 0 to 54, higher scores correspond to more severe depressive symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
Baseline, immediate post treatment (up to 2 weeks post baseline), 4 weeks and 8 weeks post treatment.
Results posted on
2026-07-29
Participant Flow
Participants received treatment over a period of 1 week starting approximately 3 - 6 days after baseline, and had follow up assessments at 4 weeks and 8 weeks post treatment.
Two participants who completed screening withdrew prior to assignment to a study arm.
Participant milestones
| Measure |
Active TBS-DLPFC
Participants receive theta-burst transcranial magnetic stimulation (TMS) to the left dorsolateral prefrontal cortex (DLPFC).
|
Active TBS-DMPFC
Participants receive intermittent theta-burst TBS to the dorsomedial prefrontal cortex (DMPFC).
|
Sham TBS
Participants receive sham theta-burst TMS stimulation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
22
|
|
Overall Study
COMPLETED
|
21
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Personalized Therapeutic Neuromodulation for Anhedonic Depression
Baseline characteristics by cohort
| Measure |
Active TBS-DLPFC
n=21 Participants
Participants receive intermittent theta-burst TMS to the left DLPFC.
|
Active TBS-DMPFC
n=19 Participants
Participants receive intermittent theta-burst TBS to the DMPFC.
|
Sham TBS
n=21 Participants
Participants receive sham theta-burst TMS stimulation.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
19 Participants
n=267 Participants
|
56 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=9 Participants
|
18 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
51 Participants
n=265 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
10 Participants
n=265 Participants
|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 16.2 • n=9 Participants
|
38.8 years
STANDARD_DEVIATION 12.4 • n=27 Participants
|
15.6 years
STANDARD_DEVIATION 15.2 • n=267 Participants
|
47.2 years
STANDARD_DEVIATION 15.6 • n=265 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
13 Participants
n=267 Participants
|
33 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
28 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
52 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
28.57 score on a scale
STANDARD_DEVIATION 7.14 • n=9 Participants
|
24.68 score on a scale
STANDARD_DEVIATION 2.08 • n=27 Participants
|
27.43 score on a scale
STANDARD_DEVIATION 4.83 • n=267 Participants
|
26.97 score on a scale
STANDARD_DEVIATION 5.93 • n=265 Participants
|
|
Snaith-Hamilton Pleasure Scale (SHAPS)
|
9.29 score on a scale
STANDARD_DEVIATION 4.11 • n=9 Participants
|
9.19 score on a scale
STANDARD_DEVIATION 2.79 • n=27 Participants
|
7.16 score on a scale
STANDARD_DEVIATION 2.65 • n=267 Participants
|
8.59 score on a scale
STANDARD_DEVIATION 3.36 • n=265 Participants
|
PRIMARY outcome
Timeframe: Baseline, immediate post treatment (up to 2 weeks post baseline), 4 weeks and 8 weeks post treatment.Population: Participants who completed the protocol
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item self-survey administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Score range: 0 to 54, higher scores correspond to more severe depressive symptoms.
Outcome measures
| Measure |
Active TBS-DLPFC
n=21 Participants
Participants receive intermittent theta-burst TMS to the left DLPFC.
|
Active TBS-DMPFC
n=19 Participants
Participants receive intermittent theta-burst TBS to the DMPFC.
|
Sham TBS
n=21 Participants
Participants receive sham theta-burst TMS stimulation.
|
|---|---|---|---|
|
Percentage Change in MADRS Score
Change at 4 Weeks Post Treatment
|
20.10 percentage of change
Standard Deviation 31.22
|
23.04 percentage of change
Standard Deviation 35.40
|
18.21 percentage of change
Standard Deviation 37.20
|
|
Percentage Change in MADRS Score
Change at 8 Weeks Post Treatment
|
16.44 percentage of change
Standard Deviation 24.86
|
28.15 percentage of change
Standard Deviation 23.99
|
7.61 percentage of change
Standard Deviation 32.35
|
|
Percentage Change in MADRS Score
Change Immediately Post Treatment
|
32.06 percentage of change
Standard Deviation 34.95
|
26.30 percentage of change
Standard Deviation 37.42
|
25.13 percentage of change
Standard Deviation 35.61
|
PRIMARY outcome
Timeframe: Baseline, immediate post treatment (up to 2 weeks post baseline), 4 week and 8 week post treatment.Population: Participants who completed the protocol
The Snaith-Hamilton Pleasure Scale is a 14-item self-report questionnaire designed to measure the reduced ability to experience pleasure. Score range: 0 to 14, higher scores indicate higher levels of anhedonia.
Outcome measures
| Measure |
Active TBS-DLPFC
n=21 Participants
Participants receive intermittent theta-burst TMS to the left DLPFC.
|
Active TBS-DMPFC
n=19 Participants
Participants receive intermittent theta-burst TBS to the DMPFC.
|
Sham TBS
n=21 Participants
Participants receive sham theta-burst TMS stimulation.
|
|---|---|---|---|
|
Percentage Change in SHAPS Score
Change Immediately Post Treatment
|
38.17 percentage of change
Standard Deviation 47.24
|
18.97 percentage of change
Standard Deviation 79.58
|
14.20 percentage of change
Standard Deviation 80.14
|
|
Percentage Change in SHAPS Score
Change at 4 Week Post Treatment
|
32.10 percentage of change
Standard Deviation 54.97
|
29.60 percentage of change
Standard Deviation 58.51
|
12.40 percentage of change
Standard Deviation 56.95
|
|
Percentage Change in SHAPS Score
Change at 8 Week Post Treatment
|
38.07 percentage of change
Standard Deviation 54.26
|
36.72 percentage of change
Standard Deviation 27.34
|
19.45 percentage of change
Standard Deviation 56.08
|
Adverse Events
Active TBS-DLPFC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active TBS-DMPFC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham TBS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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