Trial Outcomes & Findings for iTBS in Bipolar I Depression (NCT NCT05375214)

NCT ID: NCT05375214

Last Updated: 2024-08-01

Results Overview

The MADRS is a ten-item clinician rated questionnaire that helps rate the severity of depression. Total scores can range from 0 to 60, with higher scores indicating greater severity of depression (0-6 normal range, 7-19 mild depression, 20-34 moderate depression, \>34 severe depression). MADRS score will be assessed at baseline visit and immediate follow-up visit (which occurs within 5 days after treatment end). The change in MADRS score is calculated by baseline - immediate follow-up visit score.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: baseline and post treatment up to 5 days
• Results posted on: 2024-08-01

Participant Flow

Participant milestones

Measure	Treatment Arm Open label study, all participants will receive novel intermittent theta-burst stimulation (iTBS) protocol, SAINT®(Stanford Accelerated Intelligent Neuromodulation Therapy)
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

iTBS in Bipolar I Depression

Baseline characteristics by cohort

Measure	Treatment Arm n=10 Participants Open label study, all participants will receive novel iTBS protocol, SAINT®(Stanford Accelerated Intelligent Neuromodulation Therapy)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Montgomery-Asberg Depression Rating Scale (MADRS) Score	29.8 score on a scale STANDARD_DEVIATION 5.7 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and post treatment up to 5 days

The MADRS is a ten-item clinician rated questionnaire that helps rate the severity of depression. Total scores can range from 0 to 60, with higher scores indicating greater severity of depression (0-6 normal range, 7-19 mild depression, 20-34 moderate depression, >34 severe depression).

MADRS score will be assessed at baseline visit and immediate follow-up visit (which occurs within 5 days after treatment end). The change in MADRS score is calculated by baseline - immediate follow-up visit score.

Outcome measures

Measure	Treatment Arm n=10 Participants Open label study, all participants will receive novel iTBS protocol, SAINT®(Stanford Accelerated Intelligent Neuromodulation Therapy)
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score	16.9 score on a scale Standard Deviation 6.7

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment Arm n=10 participants at risk Open label study, all participants will receive novel iTBS protocol, SAINT®(Stanford Accelerated Intelligent Neuromodulation Therapy)
General disorders mild headache	20.0% 2/10 • up to 1 month

Additional Information

Kevin Li

Johns Hopkins University

Phone: 443-475-0671

Email: kevinli@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place