Status:Not yet recruiting
Keywords:TMS , Depression , Post Partum , Transcranial Magnetic Stimulation
This is a minimal risk study as we are using an FDA approved treatment in the approved population. This is an open label study to specifically look at a subset of approved patients.
· Evaluate the antidepressant effectiveness of acute treatment with NeuroStar TMS Therapy in patients with MDD with postpartum onset.
· Determine the longer term durability of the acute treatment response in the study population in clinical follow up for 12 months.
· Determine the safety of NeuroStar TMS Therapy by assessment of any medically significant, device-related adverse events during acute treatment and in 12 month follow up.
· Determine the safety of NeuroStar TMS Therapy by assessment of maternal and infant interactions on standardized bonding questionnaires.
Principle Investigator: Howard Weeks
Principle Department: Psychiatry
In order to be eligible to participate in this study, all patients must meet the following criteria prior to entry into pre-study phase:
a. Female outpatients, 18 to 50 years of age;
b. Primary diagnosis by DSM-IV criteria for Major Depressive Episode, symptoms onset within 6 months following birth, with the additional stipulation of a duration for this episode of ³ 2 weeks;
c. HAMD17 total score of greater than or equal to 18 ; and EPDS>9
d. Onset of current illness within 6 months of live childbirth
e On no antidepressant or other psychotropic medications
f Capable and willing to provide informed consent;
g. Signed HIPAA authorization;
h. Able to adhere with the treatment schedule.
Any of the following will exclude a patient from the study at any time during the study:
a. Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption);
b. 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).
c. An Axis II Personality Disorder, which in the judgment of the Investigator may hinder the patient in completing the procedures required by the study protocol.
d. 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;
· Parkinson’s disease;
· Huntington’s chorea;
· Multiple sclerosis.
e. Inability to locate and quantify a motor threshold as defined in TMS Treatment Dosing and Administration section;
f. Increased risk of seizure for any reason, including but not limited to prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for ³ 5 minutes;
g. Failure to respond to an adequate course of TMS therapy for major depressive disorder;
h. History of treatment with Vagus Nerve Stimulation;
i. Use of any investigational drug within four weeks of the screen visit;
j. History of failure to respond to an adequate course of ECT treatment;
k. Use of fluoxetine within six weeks of the screen visit;
l. Use of an MAOI within two weeks of the screen visit;
m. Use of any medication(s) in the medication classes listed on the Excluded Concomitant Medication List (see SRM) within one week of the screen visit;
n. Significant acute suicide risk, defined as follows:
· Suicide attempt within the previous six months that required medical treatment; or
· 2 or more suicide attempts in the past 12 months; or
· Has a clear-cut plan for suicide and states that he/she cannot guarantee that he/she will call his/her regular psychiatrist or the investigator if the impulse to implement the plan becomes substantial during the study; or
· In the Investigator’s opinion, is likely to attempt suicide within the next 12 months.
o. Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease;
p. 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;
q. If participating in psychotherapy, must have been in stable treatment for at least three months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the TMS trial;
r. Known or suspected pregnancy;
s. Any medical condition which, in the opinion of the Investigator would preclude the patient’s participation in the study;
t. If, in the opinion of the Investigator, the patient’s participation in the study would affect the safety of their infant
u. Women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse.