Neuromarkers Identification in Major Depressive Disorder Based on Monitoring Measures

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02222012
• Date of registration: 17/08/2014
• Prospective Registration: No
• Primary sponsor: Shalvata Mental Health Center
• Public title: Neuromarkers Identification in Major Depressive Disorder Based on Monitoring Measures
• Scientific title: Identification of Neuromarkers in Novel Neuromodulation Treatment in Major Depressive Disorder Based on Integration of Multiple Monitoring Measures
• Date of first enrolment: August 2014
• Target sample size: 20
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT02222012
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Yuval Bloch, Md, Phd
• Affiliation: Shalvata Mental Health Center

• Name: Yechiel MD Levkovitz, Phd

• Name: Yuval Bloch, MD, Phd

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Device: single channel "Multiway Coil®"

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

Primary Outcome(s)

Clinical antidepressant response as defined by decline of HDRS-21 score over time [Time Frame: 20 day]

Secondary Outcome(s)

Clinical antidepressant remission as defined by decline of HDRS-21 score over time [Time Frame: Day 20]

Symptomatic improvement [Time Frame: day 20]

Secondary ID(s)

sha-04-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Beer Yaakov Mental Health Center