Trial Outcomes & Findings for A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Bipolar Depression (NCT NCT00699218)

Results Overview

Scored Questionnaire 0-52, A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression. The higher score means more severe depression.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

5 weeks

Results posted on

2018-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Active rTMS treatment Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.: High frequency repetitive TMS given daily on weekdays for 3 weeks
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Bipolar Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=15 Participants Active rTMS treatment Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.: High frequency repetitive TMS given daily on weekdays for 3 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	50 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks

Scored Questionnaire 0-52, A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression. The higher score means more severe depression.

Outcome measures

Outcome measures
Measure	Experimental n=15 Participants Active rTMS treatment Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.: High frequency repetitive TMS given daily on weekdays for 3 weeks
Hamilton Rating Scale for Depression (HAM-D) Week 1	18.4 units on a scale Standard Deviation 8.7
Hamilton Rating Scale for Depression (HAM-D) Week 2	13.4 units on a scale Standard Deviation 6.8
Hamilton Rating Scale for Depression (HAM-D) Week 3	12.4 units on a scale Standard Deviation 6.8
Hamilton Rating Scale for Depression (HAM-D) Week 5	13.7 units on a scale Standard Deviation 7.4

SECONDARY outcome

Timeframe: 5 weeks

Self reported depression scale range 0-84. Questionnaire administered at 1,2, and 3 weeks (end of treatment). We also did a 5 week follow-up. The higher scores indicate greater or more severe depression.

Outcome measures

Outcome measures
Measure	Experimental n=15 Participants Active rTMS treatment Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.: High frequency repetitive TMS given daily on weekdays for 3 weeks
Inventory of Depressive Symptomatology Week 1	41.1 units on a scale Standard Deviation 10.2
Inventory of Depressive Symptomatology Week 2	34.3 units on a scale Standard Deviation 15.5
Inventory of Depressive Symptomatology Week 3	30.5 units on a scale Standard Deviation 16.1
Inventory of Depressive Symptomatology Week 5	31.9 units on a scale Standard Deviation 15.2

Adverse Events

rTMS Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	rTMS Treatment n=15 participants at risk Active rTMS treatment Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.: High frequency repetitive TMS given daily on weekdays for 3 weeks
Skin and subcutaneous tissue disorders Mild Focal Pain	20.0% 3/15

Additional Information

Guohua Xia

UC Davis

Phone: 916-734-3574

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place