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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Neuronetics
Sponsor:
Information provided by (Responsible Party):
Neuronetics
ClinicalTrials.gov Identifier:
NCT01842542
First received: April 19, 2013
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of acute NeuroStar TMS therapy in women who have postpartum depression.


Condition Intervention
Depression, Postpartum
Device: NeuroStar Transcranial Magnetic Stimulation (TMS)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Neuronetics:

Primary Outcome Measures:
  • Evaluate the antidepressant effectiveness of acute treatment with NeuroStar TMS Therapy in patients with MDD with postpartum onset [ Time Frame: up to 8 weeks. ] [ Designated as safety issue: Yes ]
    Acute NeuroStar TMS treatment of 5 days per week for upto 8 weeks.


Secondary Outcome Measures:
  • Determine the safety of NeuroStar TMS Therapy. [ Time Frame: upto 8 weeks plus 3 week taper. ] [ Designated as safety issue: Yes ]
    Medically significant, device related adverse events will be collected during the acute and taper phase.


Other Outcome Measures:
  • Determine the safety of NeuroStar TMS Therapy by assessment of maternal and infant interactions on standardized bonding questionnaires. [ Time Frame: Up to 8 weeks plus 3 week taper. ] [ Designated as safety issue: Yes ]
    Patients complete questionnaires during the acute and taper treatment phase at protocol specific timepoints.


Estimated Enrollment: 25
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: NeuroStar TMS Therapy Treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842542

Contacts
Contact: Darlene Lambert-Christie 610-981-4122 dlchristie@neuronetics.com
Contact: Angela Waltman 610-981-4139 awaltman@neuronetics.com

Locations
United States, Connecticut
Hartford Hospital Institute of Living Recruiting
Hartford, Connecticut, United States, 06102
Contact: Sherri Post    860-545-7476    sherri.post@hhchealth.org   
Principal Investigator: John Goethe, MD         
United States, Florida
UF Health Adult Psychiatry - Springhill Recruiting
Gainesville, Florida, United States, 32606
Contact: Dana Mason    352-273-8540    dmason@ufl.edu   
Principal Investigator: Richard Holbert, MD         
Harmonex Neuroscience and Research of Pensacola Recruiting
Pensacola, Florida, United States, 32502
Contact: Morgan Gradia    850-433-1656 ext 17    mgradia@harmonex.us   
Principal Investigator: Cris Jagar, MD         
University of South Florida-College of Medicine Withdrawn
Tampa, Florida, United States, 33613
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Kumail Hussain    312-942-7272    Kumail_Hussain@rush.edu   
Principal Investigator: Jeffrey Rado, MD         
United States, Kentucky
Integrative Psychiatry Completed
Louisville, Kentucky, United States, 40222
United States, New York
TMS Medical Associates of NY Terminated
New York, New York, United States, 10022
Weill Cornell Medical College Withdrawn
New York, New York, United States, 10065
United States, Pennsylvania
TMS Center of Lehigh Valley Terminated
Allentown, Pennsylvania, United States, 18104
University of Penn-Penn Center for Women's Behavioral Wellness Withdrawn
Philadelphia, Pennsylvania, United States, 19104
United States, Utah
University of Utah - Neuropsychiatric Institute Terminated
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Neuronetics
Investigators
Study Director: David Brock, MD Neuronetics, Inc.
  More Information

No publications provided

Responsible Party: Neuronetics
ClinicalTrials.gov Identifier: NCT01842542     History of Changes
Other Study ID Numbers: 44-03014-000
Study First Received: April 19, 2013
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Neuronetics:
Postpartum Depression, NeuroStar TMS Therapy, TMS

Additional relevant MeSH terms:
Depression
Depression, Postpartum
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pregnancy Complications
Puerperal Disorders

ClinicalTrials.gov processed this record on November 23, 2014