Status:
TERMINATED
Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset
Lead Sponsor:
Neuronetics
Conditions:
Depression, Postpartum
Eligibility:
FEMALE
18-50 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01842542
Start Date
December 1 2013
End Date
August 1 2015
Last Update
February 10 2025
Active Locations (8)
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1
Hartford Hospital Institute of Living
Hartford, Connecticut, United States, 06102
2
UF Health Adult Psychiatry - Springhill
Gainesville, Florida, United States, 32606
3
Harmonex Neuroscience and Research of Pensacola
Pensacola, Florida, United States, 32502
4
Rush University Medical Center
Chicago, Illinois, United States, 60612