Major Depressive DisorderNCT03711045
An Eye Tracking Study of Affective Disorder Patients With Suicide Risk
An observational study of Major Depressive Disorder and Bipolar Disorder, run by Central South University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder, Suicide
- What is being tested?
- eye-tracking
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 31 Dec 2019
- 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 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410001
About this study
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.
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Suicide
- Being tested
- eye-tracking
- Keywords
- eye-tracking, eye movement, saccade
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye-trackingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Suicide Risk Group | patients with affective disorders(eg. bipolar disorder, major depression disorder) also have a history of suicide attempt in the past 6 months. Receives: Behavioral: eye-tracking | |
| Disorder Control Group | patients with affective disorders(eg. bipolar disorder, major depression disorder) and without suicide ideation or behavior. Receives: Behavioral: eye-tracking | |
| Healthy Control Group | Not described Receives: Behavioral: eye-tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (4)
Scores in self-report assessment:Beck Depression Inventory
This scale is aimed to assess the clinical depressive symptom in the recent 7 days.
Measured: 5 minutes
Scores in self-report assessment:Beck Anxiety Inventory
This scale is aimed to assess the clinical anxieous symptom in the recent 7 days
Measured: 5 minutes
Scores in self-report assessment:Barratt Impulsiveness Scale
This scale is aimed to assess participant's impulsive trait.
Measured: 5 minutes
Scores in self-report assessment:Ruminative Response Scale
This scale is aimed to assess participant's ruminative thinking process.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingjiang Li, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711045
- Sponsor's protocol ID
- Second Xiangya hospital CSU
- Other IDs
- Mental Health Insititute
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eye Tracking Study of Affective Disorder Patients With Suicide Risk
- ClinicalTrials.gov ID
- NCT03711045
- Acronym / sponsor ID
- Second Xiangya hospital CSU
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Suicide
- Keywords
- eye-tracking, eye movement, saccade
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 18 Oct 2018 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suicide Risk Group | – | Behavioral: eye-trackingpatients with affective disorders(eg. bipolar disorder, major depression disorder) also have a history of suicide attempt in the past 6 months. |
| Disorder Control Group | – | Behavioral: eye-trackingpatients with affective disorders(eg. bipolar disorder, major depression disorder) and without suicide ideation or behavior. |
| Healthy Control Group | – | Behavioral: eye-tracking |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eye-trackingAfter 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. | Behavioural | Disorder Control Group, Healthy Control Group, Suicide Risk Group |
Primary outcome
eye movement performance during free-view task
Time frame: 1 hour
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.
4 secondary outcomes
Scores in self-report assessment:Beck Depression Inventory
Time frame: 5 minutes
Scores in self-report assessment:Beck Anxiety Inventory
Time frame: 5 minutes
Scores in self-report assessment:Barratt Impulsiveness Scale
Time frame: 5 minutes
Scores in self-report assessment:Ruminative Response Scale
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Individual participant dataSharing planned: No
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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.
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 Major Depressive Disorder and Bipolar Disorder, run by Central South University at 1 site in China.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Oct 2018. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Lingjiang, MD Ph.D. (+86 13807314575, LLJ2920@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eye movement performance during free-view task (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2018.