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

Depression, Postpartum Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01842542
• Other study ID #: 44-03014-000
• Status: Terminated
• Phase: N/A
• Start date: December 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2021
• Source: Neuronetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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.

Locations

Country	Name	City	State
United States	TMS Center of Lehigh Valley	Allentown	Pennsylvania
United States	Rush University Medical Center	Chicago	Illinois
United States	UF Health Adult Psychiatry - Springhill	Gainesville	Florida
United States	Hartford Hospital Institute of Living	Hartford	Connecticut
United States	Integrative Psychiatry	Louisville	Kentucky
United States	TMS Medical Associates of NY	New York	New York
United States	Harmonex Neuroscience and Research of Pensacola	Pensacola	Florida
United States	University of Utah - Neuropsychiatric Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Neuronetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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.