Clinical trial NCT03711045: An Eye Tracking Study of Affective Disorder Patients With Suicide Risk
Official title: An Eye Tracking Study of Affective Disorder Patients With Suicide Risk
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Depressive Disorder
Bipolar Disorder
Suicide
Keywords: eye-tracking
eye movement
saccade
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were recruited from outpatients in psychiatric clinic and clinical psychological clinic, and inpatients residing in the mental health hospital.

Most of the healthy volunteers were recruited from the advertisement posters in community and medical college.

There are two steps for screening. Firstly, each person was asked to complete the BDI (Beck Depression Inventory,21-items) to evaluate the depressive symptoms. Individuals with scores less than 13 and more than 20 were enrolled for this study.

Secondly, each individual has to be taken for a structural diagnostic interview (MINI-International Neuropsychiatric Interview, M.I.N.I.6.0.) in order to diagnosis current disorder and evaluate suicide risk by a psychiatrist who had already clinical consistency training.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: eye movement performance during free-view task
timeFrame: 1 hour
Secondary outcomes:
measure: Scores in self-report assessment:Beck Depression Inventory
timeFrame: 5 minutes
measure: Scores in self-report assessment:Beck Anxiety Inventory
timeFrame: 5 minutes
measure: Scores in self-report assessment:Barratt Impulsiveness Scale
timeFrame: 5 minutes
measure: Scores in self-report assessment:Ruminative Response Scale
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Changsha
country: China
facility: Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
References: