Suicidal DepressionNCT04813835
Cognition, Sleep, Neurophysiology of Suicidal Depressed Patients
An observational study of Suicidal Depression, run by Assiut University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicidal Depression
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Jan 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: study population are grouped to 3 groups 1. suicidal depressed patient 2. depressed patients 3. control or normal people
Who may be able to join
- Inclusion criteria:
- 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)
- all participant provided written informed consent
- 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
Who cannot join
- other psychiatric disorders
- electroconvulsive therapy in the Previous six months
- Neurologic disorders including stroke, epilepsy, brain injury and sensory disorders that precluded participating in cognitive assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Suicidal Depression
- Keywords
- cognition, sleep, neurophysiology, suicidal depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Cognition among Suicidal Depressed patients
- 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
- 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
Measured: one day
sleep among Suicidal Depressed patients
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.
Measured: 10 minutes
neurophysiological marker among Suicidal Depressed patients
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Dec 2021
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicidal DepressionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, waleed ashraf hamdy ahmed, Assiut University
- Investigators
- Mohamed F. Abd-ElAal, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813835
- Sponsor's protocol ID
- cognition Suicidal Depression
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2021
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive, Sleep, Neurophysiological Markers Among Suicidal Depressed Patients
- ClinicalTrials.gov ID
- NCT04813835
- Acronym / sponsor ID
- cognition Suicidal Depression
- Conditions
- Suicidal Depression
- Keywords
- cognition, sleep, neurophysiology, suicidal depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 24 Mar 2021 (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.
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
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- study population are grouped to 3 groups 1. suicidal depressed patient 2. depressed patients 3. control or normal people
Key inclusion criteria (5 listed)
- Inclusion criteria:
- 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)
- all participant provided written informed consent
- 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
Key exclusion criteria (3 listed)
- other psychiatric disorders
- electroconvulsive therapy in the Previous six months
- Neurologic disorders including stroke, epilepsy, brain injury and sensory disorders that precluded participating in cognitive assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- BackgroundW. S. F. Pickering; Geoffrey Walford (2000). Durkheim's Suicide: a century of research and debate. Psychology Press. p. 25.
- BackgroundHassan, 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
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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.
Mohamed F. Abd-ElAal, Professor study director
Assiut University
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 Suicidal Depression, run by Assiut 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 5 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition among Suicidal Depressed patients (time frame: one day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04813835, which also lists 2 linked publications.
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 5 Feb 2024.