Neuromarkers Identification in Major Depressive Disorder Based on Monitoring Measures

Depression Clinical Trial

Official title:

Identification of Neuromarkers in Novel Neuromodulation Treatment in Major Depressive Disorder Based on Integration of Multiple Monitoring Measures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02222012
• Other study ID #: sha-04-14
• Status: Not yet recruiting
• Phase: N/A
• First received: August 17, 2014
• Last updated: August 20, 2014
• Start date: August 2014
• Est. completion date: September 2017

Study information

• Verified date: August 2014
• Source: Shalvata Mental Health Center
• Contact: Yuval Bloch, MD, Phd
• Phone: 097478644
• Email: yuvalbl[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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®"):

1. Single Channel with a coil placed over the left PFC (10 Hz).

2. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2017
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Device:
• single channel "Multiway Coil®"
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).
• Two channels "Multiway stimulator coil®" (Brainsway Ltd.)
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).

Locations

Country	Name	City	State
Israel	Shalvata Mental Health Center	Hod-HaSharon

Sponsors (2)

Lead Sponsor	Collaborator
Shalvata Mental Health Center	Beer Yaakov Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Symptomatic improvement	Symptomatic improvement at the 4-week end point as measured with Hamilton Anxiety Rating Scale ( HARS)	day 20	No
Secondary	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.	Day 20	No
Secondary	Symptomatic improvement	Symptomatic improvement at the 4-week end point as measured with Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)	day 20	No
Secondary	Symptomatic improvement	Symptomatic improvement at the 4-week end point as measured with Clinical Global Impression (CGI)	day 20	No