Status:
WITHDRAWN
Post Marketing Study to Evaluate the Resource Utilization of Patients Suffering From Resistant Depression Treated With Deep TMS in Comparison to Treatment as Usual
Lead Sponsor:
Brainsway
Conditions:
Depression
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The aim of the study is to evaluate the efficacy of the Deep TMS compare to TAU and the different in resource utilization of treating depression with Deep TMS compare to the TAU. The current study is...
Detailed Description
many patients do not respond to antidepressant or could not tolerate the adverse events. Hence, many patients are looking for medical alternatives. Those alternatives include psychotherapy, ECT, and T...
Eligibility Criteria
Inclusion
- Outpatients
- Patients at Healthcare Partners for at least one year
- Men and women 22-68 years of age
- Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed in Health Care Partners (HCP) database by ICD-9 diagnosis code
- Subject with QIDS score \> 14 Subject with an HDRS-21 score \> 22
- If treating with antidepressants patient should be stable on treatment for at least 30 days prior to baseline visit or 45 days in case of Fluoxetine
- Capable and willing to provide informed consent
- Able to adhere to the treatment schedule
Exclusion
- QIDS-SR item 12 " Thoughts of Death or Suicide " score ≥3 or HDRS- 21 item 3 "Suicidal Ideation" score ≥3
- Depression secondary to a general medical condition, or substance- induced;
- History of substance abuse or dependence within the past 6 month (except nicotine and caffeine)
- Schizophrenic disorder
- Schizoaffective disorder
- Bipolar disorder, except when mania/hypomania was related to administration of antidepressant medications
- Major depression with psychotic features in the current episode
- Delusional disorder (current or within the past year)
- Eating disorders (current or within the past year)
- Obsessive compulsive disorder (current or within the past year)
- Post-traumatic stress disorder (current or within the past year)
- Current (or within 12 months of baseline) generalized anxiety disorder, panic disorder or social anxiety disorder as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
- Current (or within 12 months of baseline) personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
- Patients who have conductive, ferromagnetic or other magnetic- sensitive metals implanted in their head or within 30 cm of the treatment coil. Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes
- Patients who have active or inactive implants (including device leads), including cardiac pacemakers, implanted defibrillators, deep brain stimulators, cochlear implants, and vagus nerve stimulators
- Known or suspected pregnancy
- Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse
- Minimal MT found for both hands is higher than 70% of stimulator power output
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02260765
Start Date
October 1 2014
End Date
September 1 2020
Last Update
February 8 2021
Active Locations (1)
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1
Healthcare Partners
Los Angeles, California, United States, 90015