Depression, Postpartum
Conditions
Keywords
Postpartum Depression, NeuroStar TMS Therapy, TMS
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of acute NeuroStar TMS therapy in women who have postpartum depression.
Detailed description
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.
Interventions
DEVICENeuroStar 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.
Sponsors
Neuronetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Female outpatients, 18 to 50 years of age. * Diagnosis of DSM-IV defined Major Depressive Disorder, single or recurrent episode, with current episode duration of at least 2 weeks. * Onset and duration of current illness within 6 months of live childbirth. * HAMD17 total score of greater than or equal to 18 and a score on the Edinburgh Postnatal Depression scale (EPDS) greater than or equal to 10. * Patient cannot be on an antidepressant or other psychotropic medications during the study. * Capable and willing to provide informed consent. * Signed HIPAA authorization. * Able to adhere to the treatment schedule.
Exclusion criteria
* Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated): Depression secondary to a general medical condition, or substance-induced Seasonal pattern of depression as defined by DSM-IV;History of substance abuse or dependence within the past year(except nicotine and caffeine);Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes;Bipolar disorder;Eating disorder (current or within the past year);Obsessive compulsive disorder (lifetime); or Post-traumatic stress disorder (current or within the past year). * Individuals with a clinically defined neurological disorder or insult including, but not limited to:Any condition likely to be associated with increased intracranial pressure;Space occupying brain lesion;History of cerebrovascular accident;Transient ischemic attack within two years; Cerebral aneurysm; Dementia;Parkinson's disease;Huntington's chorea;Multiple sclerosis. * History of treatment with Vagus Nerve Stimulation. * History of failure to respond to an adequate course of ECT treatment. * Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease. * Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed. * Women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in EPDS Score From Baseline to End of Acute (EOA) Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Reached Remission After TMS Treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Non-compliance | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Transcranial Magnetic Stimulation (TMS) | — |
|---|---|---|
| Age, Customized | 29.9 years | — |
| EPDS Mean Baseline Score (Edinburgh Postnatal Depression Scale) | 20.6 units on a scale STANDARD_DEVIATION 4.15 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 25 participants | — |
| Sex: Female, Male Female | 25 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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.
Time frame: Pre to post treatment (Duration range 4 to 8 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Transcranial Magnetic Stimulation (TMS) | Mean Change in EPDS Score From Baseline to End of Acute (EOA) Treatment | -12.4 score on a scale | Standard Error 1.769 |
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.
Time frame: upto 8 weeks plus 3 week taper.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Label Transcranial Magnetic Stimulation (TMS) | Percentage of Patients Who Reached Remission After TMS Treatment | 14 Participants |