Trial Outcomes & Findings for Pilot Accelerated Theta Burst in Treatment-Resistant Bipolar Depression (NCT NCT03953417)

Last Updated: 2026-02-04

Results Overview

A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS consists of ten questions. Each interview question is rated from 0 to 6 with an overall score of 60 or less. Higher scores indicate increasing depressive symptoms. A total score of 0 to 6 indicates the absents of depressive symptoms, 7 to 19 indicates mild depressive symptoms, 30 to 34 indicates moderate depressive symptoms, 35 to 60 indicates severe depressive symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

Baseline and immediately post-treatment (6 days post baseline)

Results posted on

2026-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Accelerated Intermittent Theta Burst Treatment All participants will receive accelerated intermittent theta-burst stimulation. Accelerated intermittent theta-burst treatment: All participants will receive accelerated intermittent theta-burst stimulation to the left DLPFC. Treatment will be targeted by utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance. Stimulation will be delivered to left DLPFC using the MagPRo stimulator.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Accelerated Theta Burst in Treatment-Resistant Bipolar Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Accelerated Intermittent Theta Burst Treatment n=7 Participants All participants will receive accelerated intermittent theta-burst stimulation. Accelerated intermittent theta-burst treatment: All participants will receive accelerated intermittent theta-burst stimulation to the left DLPFC. Treatment will be targeted by utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance. Stimulation will be delivered to left DLPFC using the MagPRo stimulator.
Age, Categorical <=18 years	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=25 Participants
Age, Categorical >=65 years	1 Participants n=25 Participants
Age, Continuous	41 years n=25 Participants
Sex: Female, Male Female	5 Participants n=25 Participants
Sex: Female, Male Male	2 Participants n=25 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants
Race (NIH/OMB) Asian	0 Participants n=25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants
Race (NIH/OMB) Black or African American	0 Participants n=25 Participants
Race (NIH/OMB) White	7 Participants n=25 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants
Region of Enrollment United States	7 Participants n=25 Participants

PRIMARY outcome

Timeframe: Baseline and immediately post-treatment (6 days post baseline)

Population: Participants with data at the respective time point

Outcome measures

Outcome measures
Measure	Accelerated Intermittent Theta Burst Treatment n=7 Participants All participants will receive accelerated intermittent theta-burst stimulation. Accelerated intermittent theta-burst treatment: All participants will receive accelerated intermittent theta-burst stimulation to the left DLPFC. Treatment will be targeted by utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance. Stimulation will be delivered to left DLPFC using the MagPRo stimulator.
Change From Baseline Montgomery Asberg Depression Rating Scale (MADRS) Baseline	40.0 score on a scale Standard Deviation 9.8
Change From Baseline Montgomery Asberg Depression Rating Scale (MADRS) Immediate Post Treatment	5.7 score on a scale Standard Deviation 10.7

SECONDARY outcome

Timeframe: Baseline and immediate post-treatment (6 days post baseline)

Population: Participants with data at the respective time point

The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. The overall total score is a maximum of 60. Typical YMRS baseline scores can vary a lot. They depend on the patients' clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2).

Outcome measures

Outcome measures
Measure	Accelerated Intermittent Theta Burst Treatment n=5 Participants All participants will receive accelerated intermittent theta-burst stimulation. Accelerated intermittent theta-burst treatment: All participants will receive accelerated intermittent theta-burst stimulation to the left DLPFC. Treatment will be targeted by utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance. Stimulation will be delivered to left DLPFC using the MagPRo stimulator.
Change From Baseline Young Mania Rating Scale (YMRS) Baseline	0.8 score on a scale Standard Deviation 1.8
Change From Baseline Young Mania Rating Scale (YMRS) Immediate Post Treatment	0 score on a scale Standard Deviation 0

Adverse Events

Accelerated Intermittent Theta Burst Treatment

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

Principal Investigator

Stanford University

Phone: 650-736-2233

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place