Cognition, Sleep, Neurophysiology of Suicidal Depressed Patients

February 1, 2024 updated by: waleed ashraf hamdy ahmed, Assiut University

Cognitive, Sleep, Neurophysiological Markers Among Suicidal Depressed Patients

evaluation whether suicidal major depressive disorder patients show a specific pattern of cognitive, sleep and neurophysiologic impairment as compared to non- suicidal major depressive disorder patient, and studying the correlation between the cognitive impairment, the sleep disturbance and the neurophysiologic impairment and suicidal behaviour Studying the cognitive profile in suicidal patient including studying, Comprehension, Attention, language production, reasoning, problem solving and decision making

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Suicide defined as when a person killing himself directly or indirectly act, with knowing that will produce this result carried out by the victim himself .Suicide is 14th leading cause of death worldwide, responsible for 1.5% of all mortality .suicide is the cause of death most directly affected by psychological factors. There is other stressors such as financial troubles, poverty, unemployment, homelessness and war may cause suicide. About (15-40%) of people leave a suicide note. Genetics appear to account for between 38% and 55% of suicidal behaviors . Suicide rates differ significantly between countries and over time. Percentage of death in 2013 in Africa was 1% Canada 11.1% china 12.7% India 23.2% and united states 14%. suicide is ranked as 10th leading cause of death in the united states. In china suicide is 5th leading cause of death.

Of all the psychiatric disorders. major depressive disorder in associated with the highest life time risk of suicide attempt and completion. Indeed. the life time risk of completing suicide in patient with (MDD) range from (35- 40 %, )in the world. Also in patient of mood disorder (MD) range about (8-15 %) of patient attempt suicide In an suicide attempt must be understand how and why some people's thought process lead them to decide to end their lives, there is several different cognitive impairment factors that seem to increase the risk of suicidal behavior such as cognitive rigidity, thought suppression. Agitation. Future thinking and goal adjustment .

Finding from studies in which behavioral test of cognitive rigidity are administrated to suicide attempter and clinical controls have support this notion.

studies illustrate the importance of control the sleep disorders as there is relationship between sleep disorders and suicidal behavior and subsequent suicidal thoughts and either self-harm behaviors or suicide attempt after controlling depressive symptoms Some studies have shown neurophysiologic aspects of suicidal behavior. An attempt has been made to reveal a correlation of results obtained in calculating the entropy and information Saturation of EEG with signs of dysontogenesis in patients with depression with- or without suicidal signs

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

study population are grouped to 3 groups

  1. suicidal depressed patient
  2. depressed patients
  3. control or normal people

Description

Inclusion Criteria:I) patients

a. Inclusion criteria:

  1. Suicidal attempters, suicidal ideators, non-suicidal depressed were all diagnosed with major depression, or Bipolar disorder (BD) (depressive phase) by statistical manual of mental disorders. Patients meeting DSM-5 criteria. (APA-2013)
  2. all participant provided written informed consent
  3. age group above 18 years old II) control a. Inclusion criteria:

1. Match with the subjects in age group "above 18 years old" 2.no history of suicide attempt or ideation 3. no history of psychiatric disorder

Exclusion Criteria:

  1. other psychiatric disorders
  2. electroconvulsive therapy in the Previous six months
  3. Neurologic disorders including stroke, epilepsy, brain injury and sensory disorders that precluded participating in cognitive assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
suicidal depressed patients
psychiatric history suicidal scale mental state examination screening for sleep disturbance electroencephalography
depressed patients
psychiatric history suicidal scale mental state examination screening for sleep disturbance electroencephalography
control
psychiatric history suicidal scale mental state examination screening for sleep disturbance electroencephalography

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cognition among Suicidal Depressed patients
Time Frame: one day
  1. to determine the cognitive impairment among depressed suicidal patient compared to not depressed persons and to depressed non suicidal patients by 1-Mini-mental state examination: It as a basic tool used to assess the cognitive function; it includes tests of orientation, attention, memory, language and visual-spatial skills
  2. Montreal cognitive assessment scale:

The test is a one-page 30-point test administered in approximately 10 minutes. Each participant had the test individually. it was used to assess several domains of cognition such as the short term memory recall task (5 points) involves two learning trials of five nouns and delayed recall after approximately 5minutes
one day
sleep among Suicidal Depressed patients
Time Frame: 10 minutes

Epworth sleepiness scale:

The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. This can be helpful in screening of sleep disorders.
10 minutes
neurophysiological marker among Suicidal Depressed patients
Time Frame: 1 hour

Standard Electroencephalogram "EEG":

Conventional EEG will be done using the 8 channels Nihon Kohden machine '4217' employing scalp electrodes placed according to the international 10-20 system with bipolar and referential montages . for evaluation of power in alpha band
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mohamed F. Abd-ElAal, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • W. S. F. Pickering; Geoffrey Walford (2000). Durkheim's Suicide: a century of research and debate. Psychology Press. p. 25.
  • Hassan, Wageeh .A.N., Noamany, M.M.(2020). . A clinical study of suicide in patients admitted in psychiatry unit in Assiut University. Middle East Current Psychiatry 27, 26

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • cognition Suicidal Depression

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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