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The purpose of this study is to evaluate the safety and effectiveness of acute NeuroStar TMS therapy in women who have postpartum depression.
Evaluate the antidepressant effectiveness of acute treatment with NeuroStar TMS Therapy in patients with MDD with postpartum onset.
Determine the safety of NeuroStar TMS Therapy by assessment of any medically significant, device-related adverse events during acute treatment.
Determine the Safety of NeuroStar TMS Therapy by assessment of maternal and infant interactions on standardized bonding questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroStar Transcranial Magnetic Stimulation (TMS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in EPDS Score From Baseline to End of Acute (EOA) Treatment | 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. | Pre to post treatment (Duration range 4 to 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Reached Remission After TMS Treatment | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Brock, MD | Neuronetics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital Institute of Living | Hartford | Connecticut | 06102 | United States | ||
| UF Health Adult Psychiatry - Springhill |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| upto 8 weeks plus 3 week taper. |
| Gainesville |
| Florida |
| 32606 |
| United States |
| Harmonex Neuroscience and Research of Pensacola | Pensacola | Florida | 32502 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Integrative Psychiatry | Louisville | Kentucky | 40222 | United States |
| TMS Medical Associates of NY | New York | New York | 10022 | United States |
| TMS Center of Lehigh Valley | Allentown | Pennsylvania | 18104 | United States |
| University of Utah - Neuropsychiatric Institute | Salt Lake City | Utah | 84108 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| EPDS Mean Baseline Score (Edinburgh Postnatal Depression Scale) | 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 is worse outcome. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in EPDS Score From Baseline to End of Acute (EOA) Treatment | 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. | Posted | Mean | Standard Error | score on a scale | Pre to post treatment (Duration range 4 to 8 weeks) |
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| Secondary | Percentage of Patients Who Reached Remission After TMS Treatment | 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. | Posted | Count of Participants | Participants | upto 8 weeks plus 3 week taper. |
|
11 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
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Early study termination leading to small numbers of subjects analyzed
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Neuronetics | 16123067393 | steve.erickson@neurostar.com |
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Units | Counts |
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| Participants |
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