Depression, PostpartumNCT01842542
Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset
A study testing NeuroStar Transcranial Magnetic Stimulation (TMS) in people with Depression, Postpartum, run by Neuronetics at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of acute NeuroStar TMS therapy in women who have postpartum depression. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- NeuroStar Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
TMS Center of Lehigh Valley
Allentown, Pennsylvania, 18104
Rush University Medical Center
Chicago, Illinois, 60612
UF Health Adult Psychiatry - Springhill
Gainesville, Florida, 32606
Hartford Hospital Institute of Living
Hartford, Connecticut, 06102
Integrative Psychiatry
Louisville, Kentucky, 40222
TMS Medical Associates of NY
New York, New York, 10022
Harmonex Neuroscience and Research of Pensacola
Pensacola, Florida, 32502
University of Utah - Neuropsychiatric Institute
Salt Lake City, Utah, 84108
About this study
Official title: An Open-Label Study to Evaluate the Efficacy and Safety of the Neuronetics NeuroStar TMS Therapy System in Patients With Major Depressive Disorder (MDD) With Postpartum Onset.
The purpose of this study is to evaluate the safety and effectiveness of acute NeuroStar TMS therapy in women who have postpartum depression.
Read the 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.
- Conditions
- Depression, Postpartum
- Being tested
- NeuroStar Transcranial Magnetic Stimulation (TMS)
- Keywords
- Postpartum Depression, NeuroStar TMS Therapy, TMS
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroStar Transcranial Magnetic Stimulation (TMS)Device
Also called NeuroStar TMS Therapy Treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NeuroStar Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre to post treatment (Duration range 4 to 8 weeks)
Secondary outcomes (1)
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.
Measured: upto 8 weeks plus 3 week taper.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2015
- Study completionAug 2015
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronetics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Brock, MD, Study director, Neuronetics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842542
- Sponsor's protocol ID
- 44-03014-000
- Status last verified
- Jan 2025
- First submitted
- 19 Apr 2013
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Efficacy and Safety of the Neuronetics NeuroStar TMS Therapy System in Patients With Major Depressive Disorder (MDD) With Postpartum Onset.
- ClinicalTrials.gov ID
- NCT01842542
- Acronym / sponsor ID
- 44-03014-000
- Conditions
- Depression, Postpartum
- Keywords
- Postpartum Depression, NeuroStar TMS Therapy, TMS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 25 participants (actual)
- Lead sponsor
- NeuroneticsUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Experimental | Device: NeuroStar 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroStar Transcranial Magnetic Stimulation (TMS)Also: NeuroStar TMS Therapy TreatmentAcute 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. | Device | Transcranial Magnetic Stimulation (TMS) |
Primary outcome
Mean Change in EPDS Score From Baseline to End of Acute (EOA) Treatment
Time frame: 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.
1 secondary outcome
Percentage of Patients Who Reached Remission After TMS Treatment
Time frame: upto 8 weeks plus 3 week taper.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Brock, MD study director
Neuronetics, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroStar Transcranial Magnetic Stimulation (TMS) in people with Depression, Postpartum, run by Neuronetics at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in EPDS Score From Baseline to End of Acute (EOA) Treatment (time frame: Pre to post treatment (Duration range 4 to 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.