Clinical trial NCT01842542: Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression, Postpartum
Keywords: Postpartum Depression, NeuroStar TMS Therapy, TMS
Lead sponsor: Neuronetics
Sponsor class: OTHER
First posted: 2013-04-29
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Change in EPDS Score From Baseline to End of Acute (EOA) Treatment
timeFrame: Pre to post treatment (Duration range 4 to 8 weeks)
Secondary outcomes:
measure: Percentage of Patients Who Reached Remission After TMS Treatment
timeFrame: upto 8 weeks plus 3 week taper.
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital Institute of Living
state: Connecticut
city: Gainesville
country: United States
facility: UF Health Adult Psychiatry - Springhill
state: Florida
city: Pensacola
country: United States
facility: Harmonex Neuroscience and Research of Pensacola
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Louisville
country: United States
facility: Integrative Psychiatry
state: Kentucky
city: New York
country: United States
facility: TMS Medical Associates of NY
state: New York
city: Allentown
country: United States
facility: TMS Center of Lehigh Valley
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah - Neuropsychiatric Institute
state: Utah
Study officials:
affiliation: Neuronetics, Inc.
name: David Brock, MD
role: STUDY_DIRECTOR
References: