Depressive Disorder, MajorMDDNCT03595020
Probing Prefrontal Cortex Hemodynamic Alterations for Major Depression Disorder
An observational study of Depressive Disorder, Major, run by Xijing Hospital at 1 site in China.
Trial summary
Major depression disorder (MDD) has high estimated lifetime prevalence rates of 16.6%. Currently, the diagnosis for the MDD mainly depends on patients' reports of symptoms, observed behaviors and disease course. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2017to 31 Dec 2018
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study was performed in Xijing Hospital and Xi'an Jiaotong University in China. 100 right-handed subjects meeting DSM-IV criteria for major depression were recruited by advertisement to participate in the study, and were matched with a control group of 100 comparison subjects of university staff members, university students and members of the general population.
Who may be able to join
- MDD group:
- All subjects were free of psychotropic medication for a minimum of 4 weeks; Psychiatric diagnosis was determined by DSM-IV criteria; Depressed subjects were included with 17-item Hamilton Rating Scale for Depression (HRSD) scores ≥ 18; Mini-mental State Examination(MMSE) ≥ 24; All subjects had normal or corrected-to-normal vision.
- HC group:
- All subjects were free of psychotropic medication for a minimum of 4 weeks; All subjects did not have any mental, neurological or physical diseases；HRSD scores ≤ 7; MMSE ≥ 28; All subjects had normal or corrected-to-normal vision.
Who cannot join
- Exclusion criteria were any history of neurologic trauma resulting in loss of consciousness, any current neurologic disorder, any lifetime psychiatric disorder other than major depression in the MDD subjects, or any lifetime psychiatric disorder in control subjects. Careful attention was paid to excluding substance abuse disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of psychiatry, Xijing Hospital; Research Institute of Biomedical Engineering, Xi'an Jiaotong University
Xi'an, Shaanxi, 710032
About this study
Official title: Probing Prefrontal Cortex Hemodynamic Alterations During Facial Emotion Recognition for Major Depression Disorder Through Functional Near-infrared Spectroscopy
Major depression disorder (MDD) has high estimated lifetime prevalence rates of 16.6%. Currently, the diagnosis for the MDD mainly depends on patients' reports of symptoms, observed behaviors and disease course. Establishment of clinically useful biomarkers for the MDD diagnosis would enhance patient management and treatment effect, and lead to the therapies adjusted to the individual. However, no such biomarkers have been established up to now. Therefore, the development of objective and feasible biomarkers is of special significance and a great challenge for accurate and early diagnosis and treatment of depression, in order to overcome the limitations of relying on clinical interviews alone.The ability to correctly recognize emotional states from faces is instrumental for interpersonal engagement and social functioning. Impairments processing of facial emotional expressions and biased facial emotion detection are frequently found in the MDD patients. To date, the studies on neural mechanism of the facial emotion recognition of the MDD patients were mainly based on the functional magnetic resonance imaging (fMRI). Functional near-infrared spectroscopy (fNIRS) has not been applied for the facial emotion recognition for the depression patients up to now. To bridge the important gap in the literature, we used the fNIRS methodology to investigate the neural mechanisms of facial emotion recognition for the patients with depression. We hypothesize the physiological feature of the hemodynamic responses in prefrontal cortex measured by fNIRS under the task of face emotion recognition, including the difference of the median, the Mayer wave power, the mean cross wavelet coefficient, and the mean wavelet coherence coefficient, combined with the behavior measurement (behavior accuracy and response time), could provide a reliable and feasible diagnosis approach to differentiate patients with the MDD from healthy control (HC) subjects with acceptable sensitivity and specificity.
Read the detailed description
The fMRI technique for functional imaging were limited by the fact that the individuals need to be placed in an uncomfortable or unnatural setting and foreign, noisy, dark, or claustrophobic environment (e.g., lying in a supine position in a narrow gantry with the head restrained during the entire examination), for accurate measurement during the procedure, with relatively lower temporal resolution. In contrast, a multi-channel fNIRS machine provides a completely non-invasive, quiet and mobile measurement of brain function in ordinary clinical settings and allows patients to be comfortably seated in a normal posture in a well-lit room, with higher temporal resolution making it possible to obtain a recording of the actual time course of a hemodynamic epoch in response to a specific cognitive task (e.g., facial emotion recognition task in our study) in a single trial. Additionally, due to the small operating and maintenance costs associated with NIRS, it is possible to run fNIRS study with a large sample of participants.
- Conditions
- Depressive Disorder, Major
- Keywords
- major depression disorder, functional near-infrared spectroscopy, facial emotion recognition
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MDD group | The major depression group (MDD group) received antidepressant treatment but did not interfere with drug selection. | |
| HC group | The healthy control group (HC group) don't accept intervention and treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale-17(HAMD-17) score alterations
The HAMD-17 scores are to evaluate the severity degree of depression, and the HAMD-17 scores reduction rate is used to evaluate the clinical treatment effect. If the reduction rate exceeds 50%, it indicates that the clinical treatment is effective.
Measured: Change from baseline HAMD-17 scores at 6 months
Secondary outcomes (2)
facial emotion recognition
The ability to correctly recognize emotional states from faces is instrumental for interpersonal engagement and social functioning. Impairments processing of facial emotional expressions and biased facial emotion detection are frequently found in the MDD patients. Functional near-infrared spectroscopy (fNIRS) has not been applied for the facial emotion recognition for the depression patients up to now.
Measured: Difference at facial emotion recognition between day 1 and month 6.
Pittsburgh Sleep Quality Index（PSQI）
PSQI was used to assess the quality of sleep for subjects in the recent month. The total score ranges from 0 to 21 points. The higher the score, the worse the sleep quality.
Measured: Difference at PSQI between day 1, month 3 and month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start16 Feb 2017
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an Jiaotong University
- Responsible party
- Sponsor
- Investigators
- Huaning Wang, doctorate, Study chair, Department of psychiatry, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595020
- Sponsor's protocol ID
- KY20172012-1
- Acronym
- MDD
- Status last verified
- Feb 2018
- First submitted
- 24 Jun 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zwick JC, Wolkenstein L. Facial emotion recognition, theory of mind and the role of facial mimicry in depression. J Affect Disord. 2017 Mar 1;210:90-99. doi: 10.1016/j.jad.2016.12.022. Epub 2016 Dec 19.
PubMed 28024224Tsuchida A, Fellows LK. Are you upset? Distinct roles for orbitofrontal and lateral prefrontal cortex in detecting and distinguishing facial expressions of emotion. Cereb Cortex. 2012 Dec;22(12):2904-12. doi: 10.1093/cercor/bhr370. Epub 2012 Jan 5.
PubMed 22223852Takizawa R, Fukuda M, Kawasaki S, Kasai K, Mimura M, Pu S, Noda T, Niwa S, Okazaki Y; Joint Project for Psychiatric Application of Near-Infrared Spectroscopy (JPSY-NIRS) Group. Neuroimaging-aided differential diagnosis of the depressive state. Neuroimage. 2014 Jan 15;85 Pt 1:498-507. doi: 10.1016/j.neuroimage.2013.05.126. Epub 2013 Jun 10.
PubMed 23764293
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probing Prefrontal Cortex Hemodynamic Alterations During Facial Emotion Recognition for Major Depression Disorder Through Functional Near-infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT03595020
- Acronym / sponsor ID
- MDD / KY20172012-1
- Conditions
- Depressive Disorder, Major
- Keywords
- major depression disorder, functional near-infrared spectroscopy, facial emotion recognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Xi'an Jiaotong University
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 23 Jul 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.
Major depression disorder (MDD) has high estimated lifetime prevalence rates of 16.6%. Currently, the diagnosis for the MDD mainly depends on patients' reports of symptoms, observed behaviors and disease course. Establishment of clinically useful biomarkers for the MDD diagnosis would enhance patient management and treatment effect, and lead to the therapies adjusted to the individual. However, no such biomarkers have been established up to now. Therefore, the development of objective and feasible biomarkers is of special significance and a great challenge for accurate and early diagnosis and treatment of depression, in order to overcome the limitations of relying on clinical interviews alone.The ability to correctly recognize emotional states from faces is instrumental for interpersonal engagement and social functioning. Impairments processing of facial emotional expressions and biased facial emotion detection are frequently found in the MDD patients. To date, the studies on neural mechanism of the facial emotion recognition of the MDD patients were mainly based on the functional magnetic resonance imaging (fMRI). Functional near-infrared spectroscopy (fNIRS) has not been applied for the facial emotion recognition for the depression patients up to now. To bridge the important gap in the literature, we used the fNIRS methodology to investigate the neural mechanisms of facial emotion recognition for the patients with depression. We hypothesize the physiological feature of the hemodynamic responses in prefrontal cortex measured by fNIRS under the task of face emotion recognition, including the difference of the median, the Mayer wave power, the mean cross wavelet coefficient, and the mean wavelet coherence coefficient, combined with the behavior measurement (behavior accuracy and response time), could provide a reliable and feasible diagnosis approach to differentiate patients with the MDD from healthy control (HC) subjects with acceptable sensitivity and specificity.
Detailed description
The fMRI technique for functional imaging were limited by the fact that the individuals need to be placed in an uncomfortable or unnatural setting and foreign, noisy, dark, or claustrophobic environment (e.g., lying in a supine position in a narrow gantry with the head restrained during the entire examination), for accurate measurement during the procedure, with relatively lower temporal resolution. In contrast, a multi-channel fNIRS machine provides a completely non-invasive, quiet and mobile measurement of brain function in ordinary clinical settings and allows patients to be comfortably seated in a normal posture in a well-lit room, with higher temporal resolution making it possible to obtain a recording of the actual time course of a hemodynamic epoch in response to a specific cognitive task (e.g., facial emotion recognition task in our study) in a single trial. Additionally, due to the small operating and maintenance costs associated with NIRS, it is possible to run fNIRS study with a large sample of participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDD group | – | –The major depression group (MDD group) received antidepressant treatment but did not interfere with drug selection. |
| HC group | – | –The healthy control group (HC group) don't accept intervention and treatment. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study was performed in Xijing Hospital and Xi'an Jiaotong University in China. 100 right-handed subjects meeting DSM-IV criteria for major depression were recruited by advertisement to participate in the study, and were matched with a control group of 100 comparison subjects of university staff members, university students and members of the general population.
Key inclusion criteria (4 listed)
- MDD group:
- All subjects were free of psychotropic medication for a minimum of 4 weeks; Psychiatric diagnosis was determined by DSM-IV criteria; Depressed subjects were included with 17-item Hamilton Rating Scale for Depression (HRSD) scores ≥ 18; Mini-mental State Examination(MMSE) ≥ 24; All subjects had normal or corrected-to-normal vision.
- HC group:
- All subjects were free of psychotropic medication for a minimum of 4 weeks; All subjects did not have any mental, neurological or physical diseases；HRSD scores ≤ 7; MMSE ≥ 28; All subjects had normal or corrected-to-normal vision.
Key exclusion criteria (1 listed)
- Exclusion criteria were any history of neurologic trauma resulting in loss of consciousness, any current neurologic disorder, any lifetime psychiatric disorder other than major depression in the MDD subjects, or any lifetime psychiatric disorder in control subjects. Careful attention was paid to excluding substance abuse 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
Hamilton Depression Scale-17(HAMD-17) score alterations
Time frame: Change from baseline HAMD-17 scores at 6 months
The HAMD-17 scores are to evaluate the severity degree of depression, and the HAMD-17 scores reduction rate is used to evaluate the clinical treatment effect. If the reduction rate exceeds 50%, it indicates that the clinical treatment is effective.
2 secondary outcomes
facial emotion recognition
Time frame: Difference at facial emotion recognition between day 1 and month 6.
Pittsburgh Sleep Quality Index（PSQI）
Time frame: Difference at PSQI between day 1, month 3 and month 6.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Background: PubMed 28024224Zwick JC, Wolkenstein L. Facial emotion recognition, theory of mind and the role of facial mimicry in depression. J Affect Disord. 2017 Mar 1;210:90-99. doi: 10.1016/j.jad.2016.12.022. Epub 2016 Dec 19.
- Background: PubMed 22223852Tsuchida A, Fellows LK. Are you upset? Distinct roles for orbitofrontal and lateral prefrontal cortex in detecting and distinguishing facial expressions of emotion. Cereb Cortex. 2012 Dec;22(12):2904-12. doi: 10.1093/cercor/bhr370. Epub 2012 Jan 5.
- Background: PubMed 23764293Takizawa R, Fukuda M, Kawasaki S, Kasai K, Mimura M, Pu S, Noda T, Niwa S, Okazaki Y; Joint Project for Psychiatric Application of Near-Infrared Spectroscopy (JPSY-NIRS) Group. Neuroimaging-aided differential diagnosis of the depressive state. Neuroimage. 2014 Jan 15;85 Pt 1:498-507. doi: 10.1016/j.neuroimage.2013.05.126. Epub 2013 Jun 10.
- Individual participant dataSharing planned: Undecided
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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.
Huaning Wang, doctorate study chair
Department of psychiatry, Xijing Hospital
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 Depressive Disorder, Major, run by Xijing Hospital 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 1 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 23 Jul 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?
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?
Hamilton Depression Scale-17(HAMD-17) score alterations (time frame: Change from baseline HAMD-17 scores at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03595020, which also lists 3 linked publications.
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 23 Jul 2018.