SuicideNCT04104698
Cognitive, Psychological and Electrophysiological Attributes to Suicide Among Depressed Patients
An observational study of Suicide and Major Depressive Disorder, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide, Major Depressive Disorder, Quantitative EEG (qEEG)
- What is being tested?
- Quantitative EEG
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 50 Egyptian patients will be recruited from Mansoura University Hospitals at the outpatient clinics and the inpatient department.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35516
Shady I Mashaly, MD, +201015028364, dr.shadymashaly@gmail.com
Noha a Amer, MD, +201002025960, noha.amer87@gmail.com
About this study
This study will try to provide a better understanding of the psychological, cognitive and electrophysiological factors that contribute to suicide in depressed patients.
Read the detailed description
Objectives:
- To investigate the ability of qEEG to suspect suicidal potential in patients diagnosed with major depression.
- To test the ability of some psychological and cognitive elements in determining the likelihood of suicide in such patients.
- 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.
- Conditions
- Suicide, Major Depressive Disorder, Quantitative EEG (qEEG)
- Being tested
- Quantitative EEG
- Keywords
- Suicide, Major Depression, quantitative EEG (qEEG)
- Medical subject headings
- Suicide, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative EEGDiagnostic test
Also called Resilience scale (Carl & Davidson) Arabic version, BDI (Beck Inventory II) Arabic version, Suicide probability Scale (Arabic Version), Scale of Islamic Religiosity Attitude (SIRA)
- 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:
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group (MDD with SIs) | 25 Egyptian patients diagnosed with major depression (with suicidal ideations) Receives: Diagnostic Test: Quantitative EEG | |
| Control group (MDD without SIs) | 25 Egyptian patients diagnosed with major depression (without suicidal ideations) Receives: Diagnostic Test: Quantitative EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiological attibutes to suicide among depressed patients
Quantitative Analysis of EEG tracing from depressed patients experiencing suicidal Ideations
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Oct 2019
- Primary completion15 Jul 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady Mashaly, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104698
- Sponsor's protocol ID
- MD.18.08.81
- Status last verified
- Apr 2020
- First submitted
- 24 Sep 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I am planning to include a foreigner supervisor on my thesis.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive, Psychological and Electrophysiological Attributes to Suicide Among Depressed Patients
- ClinicalTrials.gov ID
- NCT04104698
- Acronym / sponsor ID
- MD.18.08.81
- Conditions
- Suicide, Major Depressive Disorder, Quantitative EEG (qEEG)
- Keywords
- Suicide, Major Depression, quantitative EEG (qEEG)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will try to provide a better understanding of the psychological, cognitive and electrophysiological factors that contribute to suicide in depressed patients.
Detailed description
Objectives:
- To investigate the ability of qEEG to suspect suicidal potential in patients diagnosed with major depression.
- To test the ability of some psychological and cognitive elements in determining the likelihood of suicide in such patients.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group (MDD with SIs) | – | Diagnostic Test: Quantitative EEG25 Egyptian patients diagnosed with major depression (with suicidal ideations) |
| Control group (MDD without SIs) | – | Diagnostic Test: Quantitative EEG25 Egyptian patients diagnosed with major depression (without suicidal ideations) |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 50 Egyptian patients will be recruited from Mansoura University Hospitals at the outpatient clinics and the inpatient department.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Psychotic features associating depressive episode
- Bipolar depression
- The condition is due to another medical condition
- The condition is substance or medication-induced
- Intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative EEGAlso: Resilience scale (Carl & Davidson) Arabic version, BDI (Beck Inventory II) Arabic version, Suicide probability Scale (Arabic Version), Scale of Islamic Religiosity Attitude (SIRA)1. Both groups will undergo evaluation of depression severity using Beck Depression Inventory Scale-II (Arabic Version) 2. 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) 3. Both groups will do Quantitative EEG (qEEG) to detect electrical, functional and brain mapping changes {Using Neurovirtual BW III, Florida, USA) 4. 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. | Diagnostic test | Control group (MDD without SIs), Study Group (MDD with SIs) |
Primary outcome
Electrophysiological attibutes to suicide among depressed patients
Time frame: 5 months
Quantitative Analysis of EEG tracing from depressed patients experiencing suicidal Ideations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: Undecided. I am planning to include a foreigner supervisor on my thesis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide and Major Depressive Disorder, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrophysiological attibutes to suicide among depressed patients (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.