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

NCT ID: NCT01842542

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-08-31

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.

Conditions

Depression, Postpartum

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NeuroStar Transcranial Magnetic Stimulation (TMS)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

NeuroStar TMS Therapy Treatment

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Neuronetics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Brock, MD

Role: STUDY_DIRECTOR

Neuronetics, Inc.

Locations

Hartford Hospital Institute of Living

Hartford, Connecticut, United States

UF Health Adult Psychiatry - Springhill

Gainesville, Florida, United States

Harmonex Neuroscience and Research of Pensacola

Pensacola, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Integrative Psychiatry

Louisville, Kentucky, United States

TMS Medical Associates of NY

New York, New York, United States

TMS Center of Lehigh Valley

Allentown, Pennsylvania, United States

University of Utah - Neuropsychiatric Institute

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

44-03014-000

Identifier Type: -

Identifier Source: org_study_id