Trial Outcomes & Findings for Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset (NCT NCT01842542)
NCT ID: NCT01842542
Last Updated: 2025-02-10
Results Overview
The EPDS is a ten-item questionnaire used for screening for postpartum depression. Total scores range from 0 to 30. Mothers who score above 10 are likely to suffer a depressive illness, while scores above 13 are likely to represent major depression. Higher score at EOA means worse outcome. Once patient reached remission (EPDS\<9), this was EOA treatment and scores were collected.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Pre to post treatment (Duration range 4 to 8 weeks)
Results posted on
2025-02-10
Participant Flow
Unit of analysis: TMS Treatment Sessions
Participant milestones
| Measure |
Open Label Transcranial Magnetic Stimulation (TMS)
Patients will receive NeuroStar Transcranial Magnetic Stimulation (TMS) therapy treatments 5 times a week for up to 8 weeks during the acute phase, 3 times during the first week, 2 times during the second week and 1 time during the third week of the taper phase.
Efficacy Assessments will be conducted throughout the acute and taper phase at protocol specific timepoints.
NeuroStar Transcranial Magnetic Stimulation (TMS): Acute phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, five times weekly for up to 8 weeks.
3 week taper phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, 3 times during the first week, 2 times during the second week and one time during the third week. In addition to treatments, patients may receive treatment as usual at the direction of their treating physician.
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|---|---|
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Overall Study
STARTED
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25 36
|
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Overall Study
COMPLETED
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19 36
|
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Overall Study
NOT COMPLETED
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6 0
|
Reasons for withdrawal
| Measure |
Open Label Transcranial Magnetic Stimulation (TMS)
Patients will receive NeuroStar Transcranial Magnetic Stimulation (TMS) therapy treatments 5 times a week for up to 8 weeks during the acute phase, 3 times during the first week, 2 times during the second week and 1 time during the third week of the taper phase.
Efficacy Assessments will be conducted throughout the acute and taper phase at protocol specific timepoints.
NeuroStar Transcranial Magnetic Stimulation (TMS): Acute phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, five times weekly for up to 8 weeks.
3 week taper phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, 3 times during the first week, 2 times during the second week and one time during the third week. In addition to treatments, patients may receive treatment as usual at the direction of their treating physician.
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|---|---|
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Overall Study
Withdrawal by Subject
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2
|
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Overall Study
Lack of Efficacy
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1
|
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Overall Study
Protocol Non-compliance
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2
|
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Transcranial Magnetic Stimulation (TMS)
n=25 Participants
Patients will receive NeuroStar Transcranial Magnetic Stimulation (TMS) therapy treatments 5 times a week for up to 8 weeks during the acute phase, 3 times during the first week, 2 times during the second week and 1 time during the third week of the taper phase.
Efficacy Assessments will be conducted throughout the acute and taper phase at protocol specific timepoints.
NeuroStar Transcranial Magnetic Stimulation (TMS): Acute phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, five times weekly for up to 8 weeks.
3 week taper phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, 3 times during the first week, 2 times during the second week and one time during the third week. In addition to treatments, patients may receive treatment as usual at the direction of their treating physician.
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|---|---|
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Age, Customized
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29.9 years
n=25 Participants
|
|
Sex: Female, Male
Female
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25 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=25 Participants
|
|
Region of Enrollment
United States
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25 participants
n=25 Participants
|
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EPDS Mean Baseline Score (Edinburgh Postnatal Depression Scale)
|
20.6 units on a scale
STANDARD_DEVIATION 4.15 • n=25 Participants
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PRIMARY outcome
Timeframe: Pre to post treatment (Duration range 4 to 8 weeks)The EPDS is a ten-item questionnaire used for screening for postpartum depression. Total scores range from 0 to 30. Mothers who score above 10 are likely to suffer a depressive illness, while scores above 13 are likely to represent major depression. Higher score at EOA means worse outcome. Once patient reached remission (EPDS\<9), this was EOA treatment and scores were collected.
Outcome measures
| Measure |
Open Label Transcranial Magnetic Stimulation (TMS)
n=19 Participants
Patients will receive NeuroStar Transcranial Magnetic Stimulation (TMS) therapy treatments 5 times a week for up to 8 weeks during the acute phase, 3 times during the first week, 2 times during the second week and 1 time during the third week of the taper phase.
Efficacy Assessments will be conducted throughout the acute and taper phase at protocol specific timepoints.
NeuroStar Transcranial Magnetic Stimulation (TMS): Acute phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, five times weekly for up to 8 weeks.
3 week taper phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, 3 times during the first week, 2 times during the second week and one time during the third week. In addition to treatments, patients may receive treatment as usual at the direction of their treating physician.
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|---|---|
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Mean Change in EPDS Score From Baseline to End of Acute (EOA) Treatment
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-12.4 score on a scale
Standard Error 1.769
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SECONDARY outcome
Timeframe: upto 8 weeks plus 3 week taper.An EPDS score less that 10 was used to indicate "remission". The 10-question Edinburgh Postnatal Depression Scale (EPDS) is a valuable and efficient way of identifying patients at risk for ³perinatal´ depression. The EPDS is easy to administer and has proven to be an effective screening tool. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity. Women are asked to answer each question in terms of the past seven days.
Outcome measures
| Measure |
Open Label Transcranial Magnetic Stimulation (TMS)
n=19 Participants
Patients will receive NeuroStar Transcranial Magnetic Stimulation (TMS) therapy treatments 5 times a week for up to 8 weeks during the acute phase, 3 times during the first week, 2 times during the second week and 1 time during the third week of the taper phase.
Efficacy Assessments will be conducted throughout the acute and taper phase at protocol specific timepoints.
NeuroStar Transcranial Magnetic Stimulation (TMS): Acute phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, five times weekly for up to 8 weeks.
3 week taper phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, 3 times during the first week, 2 times during the second week and one time during the third week. In addition to treatments, patients may receive treatment as usual at the direction of their treating physician.
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|---|---|
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Percentage of Patients Who Reached Remission After TMS Treatment
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14 Participants
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Adverse Events
Open Label Transcranial Magnetic Stimulation (TMS)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place