An Eye Tracking Study of Affective Disorder Patients With Suicide Risk

Major Depressive Disorder Clinical Trial

Official title:

An Eye Tracking Study of Affective Disorder Patients With Suicide Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03711045
• Other study ID #: Second Xiangya hospital CSU
• Secondary ID: Mental Health In
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2018
• Source: Central South University
• Contact: Li Lingjiang, MD Ph.D.
• Phone: +86 13807314575
• Email: LLJ2920[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This research tries to investigate the validity and reliability of eye-tracking technologies by using different paradigms (eg. free-view, pro-saccade and anti-saccade) which served as a novel way of evaluating suicide risk among affective disorder patients including bipolar and unipolar depression. All the participants including health control will be assessed by clinical interviewing, self-report assessment, cognitive evaluation and eye-tracking task.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

Inclusion Criteria:

• Diagnostic and Statistical Manual,DSM-IV diagnosis of depression or Bipolar disorder

• BDI-II>20(Suicide and disorder control group); BDI-II<13,no history of depression(Health control)

• Informed consent

• suicide attempt in the past 6 months(suicide risk group)

Exclusion Criteria:

• Current or past substance abuse, psychotic disorder,obsessive compulsive disorder , Post-Traumatic Stress Disorder, in the past 6 months

• History of epilepsy or head trauma

• Eye disorders

• History of electroconvulsive therapy in the past 4 weeks.

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mood Disorders
• Suicide

Intervention

Behavioral:
• eye-tracking
After completing a demographics form, theBeck Depression Inventory,Beck Anxiety Inventory,Barratt Impulsiveness Scale and Ruminative Response Scale-21, each participant has to go to the eye-tracking room and seats in a height adjustable chair and places their chin in a chin rest which was positioned to make sure all participants' eye are in the same location relative to the camera and the monitor. There are 18 trials and 2 filler trials in the free-view task, each of which contains 4 pictures on the same screen for 25 seconds. There is also a gap screen between each trial lasting for 2 seconds when participants were asked to fixate in the center of the screen. During the experiment, participants are instructed to watch the screen as naturally as possible, and the initial location of the fixation of each trial and the total dwell time of each emotional images(negative, happy, neutral and suicide-related)and the changes of the pupil size were recorded.

Locations

Country	Name	City	State
China	Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eye movement performance during free-view task	The first fixated location and latency(msec)of eah trial, the total dwell time(msec) in each interest areas(IAs) during the whole trial to assess the attentional bias in the experiment.	1 hour
Secondary	Scores in self-report assessment:Beck Depression Inventory	This scale is aimed to assess the clinical depressive symptom in the recent 7 days.	5 minutes
Secondary	Scores in self-report assessment:Beck Anxiety Inventory	This scale is aimed to assess the clinical anxieous symptom in the recent 7 days	5 minutes
Secondary	Scores in self-report assessment:Barratt Impulsiveness Scale	This scale is aimed to assess participant's impulsive trait.	5 minutes
Secondary	Scores in self-report assessment:Ruminative Response Scale	This scale is aimed to assess participant's ruminative thinking process.	5 minutes