Neuromarkers Identification in Major Depressive Disorder Based on Monitoring Measures

NCT02222012 | Unknown DMC

• 1 other identifier: sha-04-14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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%.

  20 day

Secondary Outcomes (4)

• Symptomatic improvement

  day 20

• Clinical antidepressant remission as defined by decline of HDRS-21 score over time

  Day 20

• Symptomatic improvement

  day 20

• Symptomatic improvement

  day 20

Study Arms (2)

single channel

ACTIVE COMPARATOR

Device: single channel "Multiway Coil®"

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

EXPERIMENTAL

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

Interventions

single channel "Multiway Coil®" DEVICE

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).

single channel

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

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).

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shalvata Mental Health Center: lead
• Beer Yaakov Mental Health Center: collaborator

Study Sites (1)

Shalvata Mental Health Center

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Yuval Bloch, Md, Phd

  Shalvata Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuval Bloch, MD, Phd

CONTACT

097478644; yuvalbl@clalit.org.il

Study Design

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

Study Record Dates

• First Submitted: August 17, 2014
• First Posted: August 21, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2017
• Last Updated: August 21, 2014

Record last verified: 2014-08

Locations

IL (1)