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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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ClinicalTrials.gov Identifier: NCT01842542
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):
Neuronetics

April 19, 2013
April 29, 2013
October 27, 2015
December 2013
July 2015   (Final data collection date for primary outcome measure)
Evaluate the antidepressant effectiveness of acute treatment with NeuroStar TMS Therapy in patients with MDD with postpartum onset [ Time Frame: up to 8 weeks. ]
Acute NeuroStar TMS treatment of 5 days per week for upto 8 weeks.
Same as current
Complete list of historical versions of study NCT01842542 on ClinicalTrials.gov Archive Site
Determine the safety of NeuroStar TMS Therapy. [ Time Frame: upto 8 weeks plus 3 week taper. ]
Medically significant, device related adverse events will be collected during the acute and taper phase.
Determine the longer term durability of the acute treatment response in the study population in clinical follow up for 12 months [ Time Frame: up to 12 months ]
Patient follow up visits to occur at 3-,6-,9- and 12 months from the end of their acute NeuroStar TMS treatment.
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. ]
Patients complete questionnaires during the acute and taper treatment phase at protocol specific timepoints.
Determine the safety of NeuroStar TMS Therapy by assessment of maternal and infant interactions on standardized bonding questionnaires [ Time Frame: up to 12 months ]
Patient completed questionnaires during the acute treatment phase and long-term follow up phase at protocol specific timepoints.
 
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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Depression, Postpartum
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
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.

Intervention: Device: NeuroStar Transcranial Magnetic Stimulation (TMS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
70
August 2015
July 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01842542
44-03014-000
No
Not Provided
Not Provided
Neuronetics
Neuronetics
Not Provided
Study Director: David Brock, MD Neuronetics, Inc.
Neuronetics
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP