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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02523105

Enrollment

Registered

2015-08-14

Start date

2015-09-30

Completion date

2017-01-05

Last updated

2018-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief summary

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

Detailed 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.

Interventions

DEVICEEEG monitoring

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged 18 -70 years (Adult, Senior) * 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 Central 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.

Design outcomes

Primary

Measure	Time frame	Description
Tuning and evaluation of use of EEG analysis of brain prefrontal activity for mental status evaluation.	12 months	Outcome measures: optimal EEG device, sampling duration, frequency, and EEG measure dynamics correlation with depression clinical dynamics.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026