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Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset

Primary Purpose

Depression, Postpartum

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeuroStar Transcranial Magnetic Stimulation (TMS)
Sponsored by
Neuronetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Postpartum focused on measuring Postpartum Depression, NeuroStar TMS Therapy, TMS

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hartford Hospital Institute of Living
  • UF Health Adult Psychiatry - Springhill
  • Harmonex Neuroscience and Research of Pensacola
  • Rush University Medical Center
  • Integrative Psychiatry
  • TMS Medical Associates of NY
  • TMS Center of Lehigh Valley
  • University of Utah - Neuropsychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial Magnetic Stimulation (TMS)

Arm Description

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.

Outcomes

Primary Outcome Measures

Evaluate the antidepressant effectiveness of acute treatment with NeuroStar TMS Therapy in patients with MDD with postpartum onset
Acute NeuroStar TMS treatment of 5 days per week for upto 8 weeks.

Secondary Outcome Measures

Determine the safety of NeuroStar TMS Therapy.
Medically significant, device related adverse events will be collected during the acute and taper phase.

Full Information

First Posted
April 19, 2013
Last Updated
October 5, 2021
Sponsor
Neuronetics
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1. Study Identification

Unique Protocol Identification Number
NCT01842542
Brief Title
Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
December 2013 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuronetics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum
Keywords
Postpartum Depression, NeuroStar TMS Therapy, TMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Magnetic Stimulation (TMS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NeuroStar Transcranial Magnetic Stimulation (TMS)
Other Intervention Name(s)
NeuroStar TMS Therapy Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the antidepressant effectiveness of acute treatment with NeuroStar TMS Therapy in patients with MDD with postpartum onset
Description
Acute NeuroStar TMS treatment of 5 days per week for upto 8 weeks.
Time Frame
up to 8 weeks.
Secondary Outcome Measure Information:
Title
Determine the safety of NeuroStar TMS Therapy.
Description
Medically significant, device related adverse events will be collected during the acute and taper phase.
Time Frame
upto 8 weeks plus 3 week taper.
Other Pre-specified Outcome Measures:
Title
Determine the safety of NeuroStar TMS Therapy by assessment of maternal and infant interactions on standardized bonding questionnaires.
Description
Patients complete questionnaires during the acute and taper treatment phase at protocol specific timepoints.
Time Frame
Up to 8 weeks plus 3 week taper.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Brock, MD
Organizational Affiliation
Neuronetics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hartford Hospital Institute of Living
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
UF Health Adult Psychiatry - Springhill
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Facility Name
Harmonex Neuroscience and Research of Pensacola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32502
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Integrative Psychiatry
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40222
Country
United States
Facility Name
TMS Medical Associates of NY
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
TMS Center of Lehigh Valley
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
University of Utah - Neuropsychiatric Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset

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