Post Marketing Study to Evaluate the Resource Utilization of Patients Suffering From Resistant Depression Treated With Deep TMS in Comparison to Treatment as Usual

NCT02260765 | Withdrawn

• 1 other identifier: HCP-Post Marketing-Brainsway
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 a prospective semi-naturalistic, randomized study in which depressed patient who failed to respond to at least one medication or could not tolerate at least two antidepressants and are seeking for alternative treatment will be offered to join an open label study. The study designed as double arm study of which patient will have 50% chance to be randomized to one of the study groups. The study includes two arms. The dTMS study group will be treated according to the cleared FDA treatment protocol of 4 weeks of daily treatment following by additional 12 weeks of biweekly treatment and overall of 44 treatments. The Treatment As Usual arm will be treated by their primary care physician / psychiatrist according to the usual treatment recommend to the patient clinical status

Conditions

Depression

Keywords

Treatment as Usual = TAU

Outcome Measures

Primary Outcomes (1)

• HDRS-21

  The primary efficacy endpoint is the change from baseline to 4 weeks visit in HDRS-21 score The change in HDRS-21 from baseline to 4 weeks visit will be compared between the treatment groups using a repeated measures analysis of covariance (ANCOVA, SAS® MIXED procedure). Baseline HDRS-21, antidepressant treatment at baseline, will be used as covariates. Baseline HDRS-21 scores and antidepressant treatment at baseline will be entered as continuous variables so that the potential for co-linearity problems will be minimized. Remission is defined as HDRS-21 score \< 10. The remission rates at week 4 in the two groups will be compared using the Chi-square test or Fisher's exact test, as appropriate.

  Baseline and after 4 week from the baseline

Study Arms (2)

HCP dTMS

ACTIVE COMPARATOR

this arm will receive dTMS treatment

Device: dTMS

HCP TAU

NO INTERVENTION

this arm will continue with the same drugs that they are using usually, which mean treatment as usual

Interventions

dTMS DEVICE

The Brainsway H-Coil TMS device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep TMS by means of repetitive pulse trains at a determined frequency

HCP dTMS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brainsway: lead

Study Sites (1)

Healthcare Partners

Los Angeles, California, 90015, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Alexander Alexander Bystritsky, MD, PhD

  Healthcare Partners

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 9, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 8, 2021

Record last verified: 2021-02

Locations

US (1)