DepressionNCT02888509
Neural and Cognitive Mechanisms of Depression and Anxiety: a Multimodal MRI Study
An observational study of Depression, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
To explore the neural and cognitive mechanisms of depression (including unipolar depression and Bipolar disorder) and anxiety using multimodal MRI techniques. Read more about this study
- Who is it for?
- Ages 16 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jan 2017
- 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 16 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with major depression, bilopar, anxiety disorders were recruited from the mental health center of Chengdu, Sichuan, China.
Who may be able to join
- Age range from 16 to 55 years old.
- All patients were interviewed by two experienced psychiatrists using the Structured Clinical Interview for DSM-IV (patient edition)
Who cannot join
- Schizophrenia, mental retardation or personality disorder, any history of loss of consciousness, substance abuse, serious medical or neurological illness.
- Subjects with contraindications to MRI
Trial locations and contacts
1 site in 1 country.
Huafu Chen contact
China1 site, 1 recruiting
- Recruiting
School of Life Science and Technology, University of Electronic Science and Technology
Chengdu, Sichuan, 610054
Huafu Chen, chenhf@uestc.edu.cn
About this study
To explore the neural and cognitive mechanisms of depression (including unipolar depression and Bipolar disorder) and anxiety using multimodal MRI techniques.
- Conditions
- Depression
- Keywords
- depression, anxiety disorder, bipolar disorder, Magnetic Resonance Imaging
- Medical subject headings
- Depression, Anxiety Disorders, Bipolar Disorder
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 |
|---|---|---|
| healthy control | Well mathed with patients in age, gender, education | |
| major depression disorder | patients with major depression disorder | |
| anxiety disorder | patients with anxiety disorder | |
| bipolar depression disorder | patients with bilopar depression disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain structural and functional changes in patients
Structure and function changes in patients will be assessed by Voxel-based morphometry analysis for structural changes, as well as Regional homogeneity, Amplitude of lowfrequency fluctuation, etc, for functional changes.
Measured: one time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startJun 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (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 DepressionStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, chenhuafu, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888509
- Sponsor's protocol ID
- UESTC-chenhuafulab-002
- Status last verified
- Aug 2016
- First submitted
- 30 Aug 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Chen Y, Cui Q, Sheng W, Tang Q, Lu F, Pang Y, Nan X, He Z, Li D, Lei T, Chen H. Anomalous neurovascular coupling in patients with generalized anxiety disorder evaluated by combining cerebral blood flow and functional connectivity strength. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Dec 20;111:110379. doi: 10.1016/j.pnpbp.2021.110379. Epub 2021 Jun 7.
PubMed 34111495Yang Y, Cui Q, Pang Y, Chen Y, Tang Q, Guo X, Han S, Ameen Fateh A, Lu F, He Z, Huang J, Xie A, Li D, Lei T, Wang Y, Chen H. Frequency-specific alteration of functional connectivity density in bipolar disorder depression. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Jan 10;104:110026. doi: 10.1016/j.pnpbp.2020.110026. Epub 2020 Jul 2.
PubMed 32621959Wang Y, Wang X, Ye L, Yang Q, Cui Q, He Z, Li L, Yang X, Zou Q, Yang P, Liu D, Chen H. Spatial complexity of brain signal is altered in patients with generalized anxiety disorder. J Affect Disord. 2019 Mar 1;246:387-393. doi: 10.1016/j.jad.2018.12.107. Epub 2018 Dec 26.
PubMed 30597300
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural and Cognitive Mechanisms of Depression and Anxiety: a Multimodal MRI Study
- ClinicalTrials.gov ID
- NCT02888509
- Acronym / sponsor ID
- UESTC-chenhuafulab-002
- Conditions
- Depression
- Keywords
- depression, anxiety disorder, bipolar disorder, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 5 Sep 2016 (estimated)
- 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 explore the neural and cognitive mechanisms of depression (including unipolar depression and Bipolar disorder) and anxiety using multimodal MRI techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy control | – | –Well mathed with patients in age, gender, education |
| major depression disorder | – | –patients with major depression disorder |
| anxiety disorder | – | –patients with anxiety disorder |
| bipolar depression disorder | – | –patients with bilopar depression disorder |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with major depression, bilopar, anxiety disorders were recruited from the mental health center of Chengdu, Sichuan, China.
Key inclusion criteria (2 listed)
- Age range from 16 to 55 years old.
- All patients were interviewed by two experienced psychiatrists using the Structured Clinical Interview for DSM-IV (patient edition)
Key exclusion criteria (2 listed)
- Schizophrenia, mental retardation or personality disorder, any history of loss of consciousness, substance abuse, serious medical or neurological illness.
- Subjects with contraindications to MRI
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
Brain structural and functional changes in patients
Time frame: one time point
Structure and function changes in patients will be assessed by Voxel-based morphometry analysis for structural changes, as well as Regional homogeneity, Amplitude of lowfrequency fluctuation, etc, for functional changes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- Derived from this study: PubMed 34111495Chen Y, Cui Q, Sheng W, Tang Q, Lu F, Pang Y, Nan X, He Z, Li D, Lei T, Chen H. Anomalous neurovascular coupling in patients with generalized anxiety disorder evaluated by combining cerebral blood flow and functional connectivity strength. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Dec 20;111:110379. doi: 10.1016/j.pnpbp.2021.110379. Epub 2021 Jun 7.
- Derived from this study: PubMed 32621959Yang Y, Cui Q, Pang Y, Chen Y, Tang Q, Guo X, Han S, Ameen Fateh A, Lu F, He Z, Huang J, Xie A, Li D, Lei T, Wang Y, Chen H. Frequency-specific alteration of functional connectivity density in bipolar disorder depression. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Jan 10;104:110026. doi: 10.1016/j.pnpbp.2020.110026. Epub 2020 Jul 2.
- Derived from this study: PubMed 30597300Wang Y, Wang X, Ye L, Yang Q, Cui Q, He Z, Li L, Yang X, Zou Q, Yang P, Liu D, Chen H. Spatial complexity of brain signal is altered in patients with generalized anxiety disorder. J Affect Disord. 2019 Mar 1;246:387-393. doi: 10.1016/j.jad.2018.12.107. Epub 2018 Dec 26.
- 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.
Huafu Chen contact
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 Depression, run by University of Electronic Science and Technology of China 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 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: status not confirmed, as of the sponsor's last update on 5 Sep 2016. 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 Huafu Chen (chenhf@uestc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain structural and functional changes in patients (time frame: one time point). 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 NCT02888509, 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 5 Sep 2016.