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Neuromarkers Identification in Major Depressive Disorder Based on Monitoring Measures

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
single channel "Multiway Coil®"
Two channels "Multiway stimulator coil®" (Brainsway Ltd.)
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Outpatient
  • Diagnosed by senior psychiatrist as suffering from major depression episode according to DSM IV using the Structured Clinical Interview for DSM-4 (SCID).
  • Rating on HDRS-21>20.
  • Age: 18-68 years.
  • Treated for the current depressive episode, at least four weeks, with at least one antidepressant in accepted dose, without improvement, according to their medical chart and ATHF ( antidepressant treatment history form) instruction guidelines .
  • Gave informed consent for participation in the study.
  • Negative answers on safety screening questionnaire for transcranial magnetic stimulation.

Exclusion Criteria:

  • Diagnosis as suffering from other diagnosis on axis 1 ( like: schizophrenia, bipolar disorder, psychotic depression, geriatric depression).
  • Diagnosis as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to of borderline personality disorder.
  • Substantial suicidal risk as judged by the treating psychiatrist.
  • Attempted suicide in the past year.
  • Any current unstable medical or surgical illness.
  • History of seizure or heat convulsion.
  • History of epilepsy or seizure in first degree relatives.
  • History of head injury.
  • History of any metal in the head (outside the mouth).
  • Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips, cochlear implants or any medical pumps.
  • History of hearing loss.
  • History of drug abuse or alcoholism in the last 6 month.
  • Pregnancy or not using a reliable method of birth control.
  • Systematic and metabolic unstable disorders.
  • Inadequate communication with the patient.
  • Under custodial care.
  • Participation in current clinical study or clinical study within 30 days prior to this study.

Sites / Locations

  • Shalvata Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

single channel

Two channels "Multiway stimulator coil®" (Brainsway Ltd.)

Arm Description

Outcomes

Primary Outcome Measures

Clinical antidepressant response as defined by decline of HDRS-21 score over time
Clinical antidepressant response at the end of the treatment, defined as a decline in Hamilton depression rating scale (HDRS-21) from the baseline rating by 50%.

Secondary Outcome Measures

Symptomatic improvement
Symptomatic improvement at the 4-week end point as measured with Hamilton Anxiety Rating Scale ( HARS)
Clinical antidepressant remission as defined by decline of HDRS-21 score over time
Clinical antidepressant remission at the end of the treatment, defined as exit Hamilton Depression Rating Scale <10.
Symptomatic improvement
Symptomatic improvement at the 4-week end point as measured with Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Symptomatic improvement
Symptomatic improvement at the 4-week end point as measured with Clinical Global Impression (CGI)

Full Information

First Posted
August 17, 2014
Last Updated
August 20, 2014
Sponsor
Shalvata Mental Health Center
Collaborators
Beer Yaakov Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT02222012
Brief Title
Neuromarkers Identification in Major Depressive Disorder Based on Monitoring Measures
Official Title
Identification of Neuromarkers in Novel Neuromodulation Treatment in Major Depressive Disorder Based on Integration of Multiple Monitoring Measures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shalvata Mental Health Center
Collaborators
Beer Yaakov Mental Health Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators propose a multi-source pattern which integrates neuroimaging data associated with multiple, symptom-related neural processes relevant in depression to improve classification accuracy. The investigators conclude that combining brain activation related to the core-symptoms of depression using the multi-source monitoring data substantially increases classification accuracy while providing a sparse relational neuromarkers-model for future prediction.
Detailed Description
The "Multiway stimulator coil®" (Brainsway Ltd.) is a novel TMS stimulator with several new and unique properties. Currently standard TMS devices include a single channel, and can operate only a single coil. The "Multiway stimulator coil®" (Brainsway Ltd.) includes two channels which can operate two independent TMS coils, either simultaneously or sequentially. The "Multiway stimulator coil®" (Brainsway Ltd.) may be used to obtain a differential activation of various brain regions. For instance it can be used to induce high frequency stimulation of a certain brain region, thus inducing facilitation, while simultaneously stimulate at low frequency in another brain region, leading to inhibition. In the current study the investigators propose a multi-source pattern which integrates neuroimaging data associated with multiple, symptom-related neural processes relevant in depression to improve classification accuracy. The investigators conclude that combining brain activation related to the core-symptoms of depression using the multi-source monitoring data substantially increases classification accuracy while providing a sparse relational neuromarkers-model for future prediction. The purpose of the study is to to monitor and optimize the anti depressive effect of brain modulation technique using novel multi model monitoring approach. Subjects will be treated with one of two designs of the study device (the "Multiway Coil®"): Single Channel with a coil placed over the left PFC (10 Hz). Two channels: a. 10 Hz over the left PFC. b. 1 Hz over the right PFC. All subjects in the current study will undergo monitoring procedure inclusive of functional MRI and electroencephalogram.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single channel
Arm Type
Active Comparator
Arm Title
Two channels "Multiway stimulator coil®" (Brainsway Ltd.)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
single channel "Multiway Coil®"
Intervention Description
During the single channel treatment trial period the patients will receive the following dose of rTMS: 10 Hz - left DLPFC ( 10 Hz, at 120% MT, 3 sec pulse train, 20 second inter-train interval, 55 trains, i.e. a total of 1650 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 33,000pulses in 4 weeks).
Intervention Type
Device
Intervention Name(s)
Two channels "Multiway stimulator coil®" (Brainsway Ltd.)
Intervention Description
During the two channels treatment trial period the patients will receive the following dose of rTMS: 10 Hz- left DLPFC, 1Hz - right DLPFC together. 10 Hz protocol: ( 10 Hz, at 120% MT, 3 sec pulse train, 20 second inter-train interval, 55 trains, i.e. a total of 1650 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 33,000pulses in 4 weeks) 1 Hz protocol: 1 Hz, at 120% MT, 5 min pulse train, 1 min inter-train interval, 6 trains, i.e. a total of 1800 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 36,000 pulses in 4 weeks).
Primary Outcome Measure Information:
Title
Clinical antidepressant response as defined by decline of HDRS-21 score over time
Description
Clinical antidepressant response at the end of the treatment, defined as a decline in Hamilton depression rating scale (HDRS-21) from the baseline rating by 50%.
Time Frame
20 day
Secondary Outcome Measure Information:
Title
Symptomatic improvement
Description
Symptomatic improvement at the 4-week end point as measured with Hamilton Anxiety Rating Scale ( HARS)
Time Frame
day 20
Title
Clinical antidepressant remission as defined by decline of HDRS-21 score over time
Description
Clinical antidepressant remission at the end of the treatment, defined as exit Hamilton Depression Rating Scale <10.
Time Frame
Day 20
Title
Symptomatic improvement
Description
Symptomatic improvement at the 4-week end point as measured with Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Time Frame
day 20
Title
Symptomatic improvement
Description
Symptomatic improvement at the 4-week end point as measured with Clinical Global Impression (CGI)
Time Frame
day 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Outpatient Diagnosed by senior psychiatrist as suffering from major depression episode according to DSM IV using the Structured Clinical Interview for DSM-4 (SCID). Rating on HDRS-21>20. Age: 18-68 years. Treated for the current depressive episode, at least four weeks, with at least one antidepressant in accepted dose, without improvement, according to their medical chart and ATHF ( antidepressant treatment history form) instruction guidelines . Gave informed consent for participation in the study. Negative answers on safety screening questionnaire for transcranial magnetic stimulation. Exclusion Criteria: Diagnosis as suffering from other diagnosis on axis 1 ( like: schizophrenia, bipolar disorder, psychotic depression, geriatric depression). Diagnosis as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to of borderline personality disorder. Substantial suicidal risk as judged by the treating psychiatrist. Attempted suicide in the past year. Any current unstable medical or surgical illness. History of seizure or heat convulsion. History of epilepsy or seizure in first degree relatives. History of head injury. History of any metal in the head (outside the mouth). Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips, cochlear implants or any medical pumps. History of hearing loss. History of drug abuse or alcoholism in the last 6 month. Pregnancy or not using a reliable method of birth control. Systematic and metabolic unstable disorders. Inadequate communication with the patient. Under custodial care. Participation in current clinical study or clinical study within 30 days prior to this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuval Bloch, MD, Phd
Phone
097478644
Email
yuvalbl@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuval Bloch, Md, Phd
Organizational Affiliation
Shalvata Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalvata Mental Health Center
City
Hod-HaSharon
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yechiel MD Levkovitz, Phd
First Name & Middle Initial & Last Name & Degree
Yuval Bloch, MD Phd

12. IPD Sharing Statement

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Neuromarkers Identification in Major Depressive Disorder Based on Monitoring Measures

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