Trial Outcomes & Findings for Imaging Biomarkers for TMS Treatment of Depression (NCT NCT01900314)

NCT ID: NCT01900314

Last Updated: 2017-04-25

Results Overview

MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 4 weeks after baseline
• Results posted on: 2017-04-25

Participant Flow

Subjects were recruited between October 2013 and October 2015. Subjects exhibited moderate levels of treatment resistance

44 patients were screened in person and 40 consented for the study.

Participant milestones

Measure	Active rTMS 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second functional magnetic resonance imaging scan will be completed then 5 additional tapering treatments of rTMS over a 2 week period. repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.	Sham rTMS 20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second functional magnetic resonance imaging scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period. repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.
Overall Study STARTED	20	20
Overall Study Completed MRI#1	17	17
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	Active rTMS 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second functional magnetic resonance imaging scan will be completed then 5 additional tapering treatments of rTMS over a 2 week period. repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.	Sham rTMS 20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second functional magnetic resonance imaging scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period. repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

Imaging Biomarkers for TMS Treatment of Depression

Baseline characteristics by cohort

Measure	Active rTMS n=16 Participants 20 active sessions	Sham rTMS n=16 Participants 20 sham sessions	Total n=32 Participants Total of all reporting groups
Age, Continuous	46.9 years STANDARD_DEVIATION 10.7 • n=5 Participants	44.1 years STANDARD_DEVIATION 11.1 • n=7 Participants	45.5 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
MADRS	25.4 units on a scale STANDARD_DEVIATION 5.7 • n=5 Participants	21.9 units on a scale STANDARD_DEVIATION 3.1 • n=7 Participants	23.5 units on a scale STANDARD_DEVIATION 5.1 • n=5 Participants
HRSD-17	16 units on a scale STANDARD_DEVIATION 3.9 • n=5 Participants	13.1 units on a scale STANDARD_DEVIATION 2.3 • n=7 Participants	14.2 units on a scale STANDARD_DEVIATION 4.4 • n=5 Participants
Global assessment of Function (GAF)	52.6 units on a scale STANDARD_DEVIATION 4.7 • n=5 Participants	55.6 units on a scale STANDARD_DEVIATION 4.3 • n=7 Participants	54.1 units on a scale STANDARD_DEVIATION 4.6 • n=5 Participants
Antidepressant Treatment History Form (ATHF-current)	2.56 units on a scale STANDARD_DEVIATION 1.75 • n=5 Participants	2.94 units on a scale STANDARD_DEVIATION 1.77 • n=7 Participants	2.75 units on a scale STANDARD_DEVIATION 1.74 • n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks after baseline

MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression

Outcome measures

Measure	Active rTMS n=16 Participants 20 active sessions of rTMS	Sham rTMS n=16 Participants 20 sham sessions
Depressive Symptoms at 4 Weeks	15.6 units on a scale Standard Deviation 8.3	15.6 units on a scale Standard Deviation 8.3

SECONDARY outcome

Timeframe: 4 weeks after baseline

Population: Sample analyzed included all participants who entered the study and received MRI scans at baseline and after 4 weeks of treatment. Repeated measures ANCOVA with screening MADRS score as co-variate

Depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale (HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22

Outcome measures

Measure	Active rTMS n=16 Participants 20 active sessions of rTMS	Sham rTMS n=16 Participants 20 sham sessions
Depression Symptoms at 4 Weeks- Secondary	9.1 units on a scale Standard Deviation 4.8	10.1 units on a scale Standard Deviation 5.2

Adverse Events

Active rTMS

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Sham rTMS

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active rTMS n=17 participants at risk 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second fMRI will be completed then 5 additional tapering treatments of rTMS over a 2 week period. repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.	Sham rTMS n=17 participants at risk 20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second fMRI scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period. repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.
Musculoskeletal and connective tissue disorders Pain	11.8% 2/17 • Number of events 3 • Adverse events assessed during 4 weeks of double-blinded treatment	5.9% 1/17 • Number of events 1 • Adverse events assessed during 4 weeks of double-blinded treatment
Nervous system disorders Headache	0.00% 0/17 • Adverse events assessed during 4 weeks of double-blinded treatment	11.8% 2/17 • Number of events 2 • Adverse events assessed during 4 weeks of double-blinded treatment
Nervous system disorders Fatigue	0.00% 0/17 • Adverse events assessed during 4 weeks of double-blinded treatment	5.9% 1/17 • Number of events 1 • Adverse events assessed during 4 weeks of double-blinded treatment
Nervous system disorders Insomnia	11.8% 2/17 • Number of events 3 • Adverse events assessed during 4 weeks of double-blinded treatment	5.9% 1/17 • Number of events 1 • Adverse events assessed during 4 weeks of double-blinded treatment
Nervous system disorders parathesia	11.8% 2/17 • Number of events 3 • Adverse events assessed during 4 weeks of double-blinded treatment	0.00% 0/17 • Adverse events assessed during 4 weeks of double-blinded treatment
Renal and urinary disorders Incontinence	5.9% 1/17 • Number of events 1 • Adverse events assessed during 4 weeks of double-blinded treatment	0.00% 0/17 • Adverse events assessed during 4 weeks of double-blinded treatment
Skin and subcutaneous tissue disorders lower extremity swelling	5.9% 1/17 • Number of events 1 • Adverse events assessed during 4 weeks of double-blinded treatment	0.00% 0/17 • Adverse events assessed during 4 weeks of double-blinded treatment
Respiratory, thoracic and mediastinal disorders URI symptoms	5.9% 1/17 • Number of events 1 • Adverse events assessed during 4 weeks of double-blinded treatment	0.00% 0/17 • Adverse events assessed during 4 weeks of double-blinded treatment

Additional Information

Stephan Taylor

University of Michigan

Phone: 734-936-4955

Email: sftaylor@umich.edu

Results disclosure agreements

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

Restriction type: LTE60