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

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.

Study Overview

• Status: Terminated
• Conditions: Depression, Postpartum
• Intervention / Treatment: Device: NeuroStar Transcranial Magnetic Stimulation (TMS)

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital Institute of Living
  • Florida
    • Gainesville, Florida, United States, 32606
      • UF Health Adult Psychiatry - Springhill
    • Pensacola, Florida, United States, 32502
      • Harmonex Neuroscience and Research of Pensacola
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40222
      • Integrative Psychiatry
  • New York
    • New York, New York, United States, 10022
      • TMS Medical Associates of NY
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • TMS Center of Lehigh Valley
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah - Neuropsychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Device: 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.; Other Names: NeuroStar TMS Therapy Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the safety of NeuroStar TMS Therapy.	Medically significant, device related adverse events will be collected during the acute and taper phase.	upto 8 weeks plus 3 week taper.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the safety of NeuroStar TMS Therapy by assessment of maternal and infant interactions on standardized bonding questionnaires.	Patients complete questionnaires during the acute and taper treatment phase at protocol specific timepoints.	Up to 8 weeks plus 3 week taper.

Collaborators and Investigators

• Sponsor: Neuronetics
• Investigators: Study Director: David Brock, MD, Neuronetics, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2013
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: April 19, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (ESTIMATE): April 29, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Postpartum Depression, NeuroStar TMS Therapy, TMS
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum; Depressive Disorder, Major
• Other Study ID Numbers: 44-03014-000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes