NCT04813835

Brief 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 impairment and suicidal behaviour Studying the cognitive profile in suicidal patient including studying, Comprehension, Attention, language production, reasoning, problem solving and decision making

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

February 26, 2021

Last Update Submit

February 1, 2024

Conditions

Keywords

cognitionsleepneurophysiologysuicidal depression

Outcome Measures

Primary Outcomes (3)

  • Cognition among Suicidal Depressed patients

    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

    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

    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

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

study population are grouped to 3 groups 1. suicidal depressed patient 2. depressed patients 3. control or normal people

You may qualify if:

  • 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
  • \. 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (2)

  • W. S. F. Pickering; Geoffrey Walford (2000). Durkheim's Suicide: a century of research and debate. Psychology Press. p. 25.

    BACKGROUND
  • 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

    BACKGROUND

Study Officials

  • Mohamed F. Abd-ElAal, Professor

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 24, 2021

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

February 5, 2024

Record last verified: 2024-02

Locations