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Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Bipolar Depression (NCT NCT00186485)

NCT ID: NCT00186485

Last Updated: 2017-10-06

Results Overview

The HDRS - 17 is a scale that measures the severity of depression based on the patients response to 17 questions on the presence and severity of the symptoms found in depression. The severity of a symptom is scored from 0 (not present) to 4 (most severe); total scores range from 0 (no depressive symptoms), to 68 (very severe depression). A decrease in the HDRS score reflects a reduction in depression severity.The scores are Baseline and End of Week 4

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-10-06

Participant Flow

Participant milestones

Participant milestones
Measure
Right Sided Low Frequency Unilateral TMS
1Hz unilateral TMS delivered to the right DLPFC using the MagStim device MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain
Overall Study
STARTED
28
Overall Study
COMPLETED
25
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Right Sided Low Frequency Unilateral TMS
1Hz unilateral TMS delivered to the right DLPFC using the MagStim device MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain
Overall Study
Lost to Follow-up
3

Baseline Characteristics

Based on a list of self-reported failed prior medication treatment trials.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Right Sided Low Frequency Unilateral TMS
n=28 Participants
Open treatment with 1Hz unilateral TMS delivered to the right DLPFC using the MagStim device MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain
Age, Categorical
<=18 years
0 Participants
n=28 Participants
Age, Categorical
Between 18 and 65 years
28 Participants
n=28 Participants
Age, Categorical
>=65 years
0 Participants
n=28 Participants
Age, Continuous
34.9 years
STANDARD_DEVIATION 9.8 • n=28 Participants
Sex: Female, Male
Female
18 Participants
n=28 Participants
Sex: Female, Male
Male
10 Participants
n=28 Participants
Region of Enrollment
United States
28 participants
n=28 Participants
Number of Subjects with Bipolar Subtype Diagnosis at Baseline
Bipolar Type I
16 Participants
n=28 Participants
Number of Subjects with Bipolar Subtype Diagnosis at Baseline
Bipolar Type II
11 Participants
n=28 Participants
Number of Subjects with Bipolar Subtype Diagnosis at Baseline
Bipolar NOS
1 Participants
n=28 Participants
Concurrent Medications
4 number of medications
n=25 Participants • Based on a list of self-reported failed prior medication treatment trials.
Prior Failed Medication Trials
14.6 Number of medications
STANDARD_DEVIATION 3.2 • n=28 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Subjects received 4 weeks of right sided dorsolateral prefrontal cortex 1Hz TMS, last observation carried forward

The HDRS - 17 is a scale that measures the severity of depression based on the patients response to 17 questions on the presence and severity of the symptoms found in depression. The severity of a symptom is scored from 0 (not present) to 4 (most severe); total scores range from 0 (no depressive symptoms), to 68 (very severe depression). A decrease in the HDRS score reflects a reduction in depression severity.The scores are Baseline and End of Week 4

Outcome measures

Outcome measures
Measure
Right Sided Low Frequency Unilateral TMS
n=28 Participants
1Hz unilateral TMS delivered to the right DLPFC using the MagStim device MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain
Hamilton Depression Rating Scale (HDRS) -17 Item; Baseline to End of Week 4
Baseline HDRS
23.7 units on a scale
Standard Deviation 5.9
Hamilton Depression Rating Scale (HDRS) -17 Item; Baseline to End of Week 4
End of Week 4
13.3 units on a scale
Standard Deviation 6.0

SECONDARY outcome

Timeframe: 4 weeks

Population: Subjects received 4 weeks of right sided dorsolateral prefrontal cortex 1Hz TMS, last observation carried forward

The Beck Depression Inventory Scale (BDI) measures the severity of depression based on the patients response to 21 questions on the presence and severity of the symptoms found in depression. The severity of a symptom is scored from 0 (not present) to 3 (most severe); total scores range from 0 (no depressive symptoms), to 63 (very severe depression). A decrease in the score reflects a reduction of the severity of depression.The scores are from Baseline and End of Week 4

Outcome measures

Outcome measures
Measure
Right Sided Low Frequency Unilateral TMS
n=28 Participants
1Hz unilateral TMS delivered to the right DLPFC using the MagStim device MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain
Beck Depression Inventory Score; Baseline to End of Week 4
Baseline
30.6 units on a scale
Standard Deviation 7.0
Beck Depression Inventory Score; Baseline to End of Week 4
End of week 4
19.4 units on a scale
Standard Deviation 10.2

SECONDARY outcome

Timeframe: 4 weeks

Population: Subjects received 4 weeks of right sided dorsolateral prefrontal cortex 1Hz TMS, last observation carried forward

The Clinical Global Impression of Severity (CGI-S) is a measure of depression severity and disability based on the clinicians overall impression of the severity of depression based on the patients response to open ended questions and self report of the presence and severity of the symptoms and level of disability found in depression. The CGI-S assesses the severity of illness (depression) and is scored from 1 (well, not at all ill) to 7 (among the most severely ill patients); a decrease in the CGI-S score reflects a reduction of the symptoms and disability due to depression. The scores are from Baseline and End of Week 4

Outcome measures

Outcome measures
Measure
Right Sided Low Frequency Unilateral TMS
n=25 Participants
1Hz unilateral TMS delivered to the right DLPFC using the MagStim device MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain
Clinical Global Impression - Severity; Baseline to End of Week 4
CGI-S baseline
4.9 units on a scale
Standard Deviation 0.68
Clinical Global Impression - Severity; Baseline to End of Week 4
CGI-S end of week 4
4.2 units on a scale
Standard Deviation 0.83

Adverse Events

Right Sided Low Frequency Unilateral TMS

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Right Sided Low Frequency Unilateral TMS
n=28 participants at risk
Open treatment with 1Hz unilateral TMS delivered to the right DLPFC using the MagStim device MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain
Musculoskeletal and connective tissue disorders
mild headache
21.4%
6/28 • Number of events 6 • 4 weeks

Additional Information

Dr. Hugh Brent Solvason

Stanford University

Phone: 650 776 4793

Results disclosure agreements

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