Depression DisorderNCT03551041
The Neural Representation of Self in Depression Patients
An observational study of Depression Disorder and Healthy, run by Beijing Normal University.
Trial summary
To be aware of oneself as a unique entity in the world occurs early in human development and is the prerequisite of normal social functioning. The disturbance of self representation characterizes a variety of mental disorders such as autism and schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression Disorder, Healthy
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 27 May 2014to 26 Jan 2018
- How long will I take part?
- 1 Month
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals diagnosed with depression and healthy control
Who may be able to join
- Patients should be clinical diagnosis of major depression disorder.
- Healthy control participants should be age-matched with depression group, and should have no history of neurological or psychiatric diagnoses
Who cannot join
- Patients who also have bipolar disorder, schizophrenia, anxiety disorder
- Healthy controls who have history of mental disorders
About this study
Official title: The Different Neural Representation of Self in Depression Patients and Healthy Individuals.
To be aware of oneself as a unique entity in the world occurs early in human development and is the prerequisite of normal social functioning. The disturbance of self representation characterizes a variety of mental disorders such as autism and schizophrenia. Negative self-bias was found to serve as the core cognitive mechanism of depression disorder. However, there was no evidence to show the reason lead to negative bias. In the current study, investigators hypothesized that the blurring self representation was the neural correlates in depression disorder.
Read the detailed description
To test investigators' hypothesis, investigators adopted the self-referential task and fMRI to investigate the neural representation of self in depression patients, and compared with healthy control.
- Conditions
- Depression Disorder, Healthy
- Keywords
- depression, self-referential, neural representation
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural representation of self
We adopted the self referential task. In the task, participants were asked to judge whether a given word was appropriate to describe oneself (self-judgement condition), a celebrity (other-judgement condition) by pressing one of the two buttons with the index or middle finger. For judgments of each target person (i.e, self and celebrity), there were 3 categories of words describing the mental (personality traits, such as hard-working, friendly), physical (physical attributes, such as black hair, big eyes) and social (social roles, such as student, American) dimension of person knowledge. The fMRI task contained 6 runs, with 4.6 minutes per run.
This paradigm and task allowed us to investigated the neural representation of self by comparing the BOLD activity under self-judgement condition with BOLD activity under other-judgement condition.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start27 May 2014
- Primary completion15 Jun 2017
- Study completion26 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression 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
- 23 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Beijing Normal University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University, Southwest Medical University
- Responsible party
- Principal investigator, ma, yina, Beijing Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551041
- Sponsor's protocol ID
- DepressionSelf_fMRI
- Status last verified
- Feb 2018
- First submitted
- 4 Feb 2018
- Last updated
- 11 Jun 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 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Different Neural Representation of Self in Depression Patients and Healthy Individuals.
- ClinicalTrials.gov ID
- NCT03551041
- Acronym / sponsor ID
- DepressionSelf_fMRI
- Conditions
- Depression Disorder, Healthy
- Keywords
- depression, self-referential, neural representation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Beijing Normal UniversityUniversity, hospital or other
- Collaborators
- Peking University, Southwest Medical University
- Study start
- 27 May 2014 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 11 Jun 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.
To be aware of oneself as a unique entity in the world occurs early in human development and is the prerequisite of normal social functioning. The disturbance of self representation characterizes a variety of mental disorders such as autism and schizophrenia. Negative self-bias was found to serve as the core cognitive mechanism of depression disorder. However, there was no evidence to show the reason lead to negative bias. In the current study, investigators hypothesized that the blurring self representation was the neural correlates in depression disorder.
Detailed description
To test investigators' hypothesis, investigators adopted the self-referential task and fMRI to investigate the neural representation of self in depression patients, and compared with healthy control.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals diagnosed with depression and healthy control
Key inclusion criteria (2 listed)
- Patients should be clinical diagnosis of major depression disorder.
- Healthy control participants should be age-matched with depression group, and should have no history of neurological or psychiatric diagnoses
Key exclusion criteria (2 listed)
- Patients who also have bipolar disorder, schizophrenia, anxiety disorder
- Healthy controls who have history of mental disorders
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
Neural representation of self
Time frame: through study completion, an average of 2 year
We adopted the self referential task. In the task, participants were asked to judge whether a given word was appropriate to describe oneself (self-judgement condition), a celebrity (other-judgement condition) by pressing one of the two buttons with the index or middle finger. For judgments of each target person (i.e, self and celebrity), there were 3 categories of words describing the mental (personality traits, such as hard-working, friendly), physical (physical attributes, such as black hair, big eyes) and social (social roles, such as student, American) dimension of person knowledge. The fMRI task contained 6 runs, with 4.6 minutes per run. This paradigm and task allowed us to investigated the neural representation of self by comparing the BOLD activity under self-judgement condition with BOLD activity under other-judgement condition.
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 11 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression Disorder and Healthy, run by Beijing Normal University.
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 2 inclusion and 2 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 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Neural representation of self (time frame: through study completion, an average of 2 year). 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 11 Jun 2018.