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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04104698
Other study ID # MD.18.08.81
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date August 1, 2020

Study information

Verified date April 2020
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will try to provide a better understanding of the psychological, cognitive and electrophysiological factors that contribute to suicide in depressed patients.


Description:

Objectives:

1. To investigate the ability of qEEG to suspect suicidal potential in patients diagnosed with major depression.

2. To test the ability of some psychological and cognitive elements in determining the likelihood of suicide in such patients.

3. To give an objective and more reliable method than traditional questionnaires to assess the seriousness of suicidal ideations in patients suffering from depression who usually don't reveal their actual intentions.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 1, 2020
Est. primary completion date July 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria:

- Age between 16 and 65 years

- Both males and females will be enrolled

- Patients present with the clinical picture of Major depression according to DSM 5 criteria.

Exclusion Criteria:

- Psychotic features associating depressive episode

- Bipolar depression

- The condition is due to another medical condition

- The condition is substance or medication-induced

- Intellectual disability

- Comorbid epilepsy

Study Design


Intervention

Diagnostic Test:
Quantitative EEG
Both groups will undergo evaluation of depression severity using Beck Depression Inventory Scale-II (Arabic Version) Both groups will be assessed for psychological & cognitive contributes respectively using: A. Connor and Davidson Scale for resilience (Arabic Version) B. The scale of Islamic Religiosity Attitude (SIRA) Both groups will do Quantitative EEG (qEEG) to detect electrical, functional and brain mapping changes {Using Neurovirtual BW III, Florida, USA) The quantitative analysis of EEG will focus on the following functions: Histogram, Topography, Spectrum Analysis, Spectral Differences, Propagation, Positional Diagram, Medium Amplitude, Ranges of Absolute Frequencies, Ranges of Relative Frequencies, CSA, Spectrum, and CSA Compressed.

Locations

Country Name City State
Egypt Mansoura University Hospital Mansoura Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Electrophysiological attibutes to suicide among depressed patients Quantitative Analysis of EEG tracing from depressed patients experiencing suicidal Ideations 5 months
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