Evaluation of Use of Brain Activity Monitoring for Evaluation of Depression Treatment Efficacy

Depression Clinical Trial

Official title:

Evaluation of Use of Brain Activity Monitoring for Early Identification of Pharmaceutical Treatment Efficacy and Development of Depression Deterioration Events

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02583724
• Other study ID #: EMC73-15
• Status: Recruiting
• Phase: N/A
• First received: October 1, 2015
• Last updated: July 24, 2016
• Start date: September 2015
• Est. completion date: February 2017

Study information

• Verified date: July 2016
• Source: Brainmarc Ltd.
• Contact: Shahak Yariv, Dr.
• Phone: 972-77-9331131
• Email: yariv_sh[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study evaluates the use of brain activity monitoring for early identification of pharmaceutical treatment efficacy and development of depression deterioration events.

Description:

The study will be conducted in two arms:

In arm I, participants diagnosed with depression. In arm II, healthy participants.

Arm I - Participants that need to start or switch their pharmacological antidepressant therapy will be recruited. Their clinical status will be evaluated and their EEG characteristics will be collected.

Arm II - Clinical and EEG characteristics of Healthy volunteers will collected on a similar timetable.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study.

• Male or Female, aged 18 -70 years.

• Able and willing to comply with all study requirements.

Additional Inclusion Criteria for Arm I

• Diagnosed with depression

• Being within 2 days of receiving pharmaceutical treatment for depression for the first

time or changing dose or changing type of current pharmaceutical treatment or addition to

drug of current pharmaceutical treatment.

Additional Inclusion Criteria for Arm II

Brief Symptom Inventory (BSI < 2.3).

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

• Diagnosed with Psychotic disorder.

• Diagnosed with Neurological disorder.

• A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse

or dependence.

• Hearing disorder and/or known ear drum impairment.

• High suicide risk as judged by the research team.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv).
EEG evaluation will be done using two off the shelf EEG devices for research and consumer use. The first one is a device called MindWave by NeuroSky ltd (http://neurosky.com) the second called EPOC by Emotiv ltd (https://emotiv.com/epoc.php). EEG evaluation will be conducted for a total duration of 20 minutes with and without auditory stimulation. The auditory stimulation will be performed using standard headphone or earphones to reduce external noises.

Locations

Country	Name	City	State
Israel	Haemek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
Brainmarc Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of brain electrical signal in Micro volt.	Measurements of brain electrical signal in Micro volt will be quantified by an algorithm and correlated to patients depression status (as evaluated during the study period).	12 months	No