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

NCT01842542 | Terminated Results FDA Device

• 1 other identifier: 44-03014-000
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 8

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.

Conditions

Depression, Postpartum

Keywords

Postpartum Depression, NeuroStar TMS Therapy, TMS

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Percentage of Patients Who Reached Remission After TMS Treatment

  upto 8 weeks plus 3 week taper.

Study Arms (1)

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.

Device: NeuroStar Transcranial Magnetic Stimulation (TMS)

Interventions

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.

Also known as: NeuroStar TMS Therapy Treatment

Transcranial Magnetic Stimulation (TMS)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuronetics: lead

Study Sites (8)

Hartford Hospital Institute of Living

Hartford, Connecticut, 06102, United States

Location

UF Health Adult Psychiatry - Springhill

Gainesville, Florida, 32606, United States

Location

Harmonex Neuroscience and Research of Pensacola

Pensacola, Florida, 32502, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Integrative Psychiatry

Louisville, Kentucky, 40222, United States

Location

TMS Medical Associates of NY

New York, New York, 10022, United States

Location

TMS Center of Lehigh Valley

Allentown, Pennsylvania, 18104, United States

Location

University of Utah - Neuropsychiatric Institute

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Limitations and Caveats

Early study termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Neuronetics

steve.erickson@neurostar.com

16123067393

Study Officials

• David Brock, MD

  Neuronetics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: April 29, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)