Major Depressive DisorderNCT03084042
Emotional Brain Networks & Cognitive Functioning in Depression and Anxiety
An observational study of Major Depressive Disorder and General Anxiety Disorder, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
This study aims to 1) examine common and specific emotional and cognitive dysfunctions between Major Depression and generalized anxiety disorder; 2) Examine emotional and cognitive dysfunctions between the two disorders and healthy controls; 3) Examine the biomarkers predicting successful therapy or not. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, General Anxiety Disorder
- What is being tested?
- fMRI
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Jun 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients from the hospitals and healthy controls from community
Who may be able to join
- GAD:
- Diagnosis of Generalized Anxiety Disorder (GAD) according to DSM V criteria in a structured clinical interview for DSM-V Axis I disorders (SCID I; APA, 2014) and a confirmatory clinical interview
- Duration of the current episode > 3 weeks
- MDD:
- Diagnosis of current major depressive disorder in a structured clinical interview for DSM-V Axis I disorders (SCID I; APA, 2014) and a confirmatory clinical interview
- Duration of the current episode > 4 weeks
Who cannot join
- GAD: diagnosis of any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months
- MDD: diagnosis of any other psychiatric Axis I disorder (except MDD) as a principal diagnosis within the past six months
Trial locations and contacts
1 site in 1 country.
Benjamin Becker, Dr. contact
China1 site, 1 recruiting
- Recruiting
School of Life Science and Technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
Benjamin Becker, Dr., ben_becker@gmx.de
About this study
This study aims to 1) examine common and specific emotional and cognitive dysfunctions between Major Depression and generalized anxiety disorder; 2) Examine emotional and cognitive dysfunctions between the two disorders and healthy controls; 3) Examine the biomarkers predicting successful therapy or not.
- Being tested
- fMRI
- Keywords
- emotional impairments, cognitive impairments
- Medical subject headings
- Depressive Disorder, Major, Generalized Anxiety Disorder, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Depression patients (MDD) | Patients with diagnosis of major depression according to DSM criteria Receives: Device: fMRI | |
| Anxiety patients (GAD) | Patients with generalized anxiety disorder according to DSM criteria Receives: Device: fMRI | |
| Healthy controls | Demographically matched healthy controls. Receives: Device: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity in the emotional and cognitive core regions of the brain as assessed by fMRI
fMRI based indices during emotional face processing
Measured: 1 hour (assessed at study inclusion)
Brain activity in the emotional and cognitive core regions of the brain as assessed by fMRI
fMRI based indices during empathy processing
Measured: 1 hour (assessed at study inclusion)
Brain activity in the emotional and cognitive core regions of the brain as assessed by fMRI
fMRI based indices during working memory
Measured: 1 hour (assessed at study inclusion)
Secondary outcomes (6)
Behavioral performance during the fMRI: face processing
Accuracy during face processing
Measured: 1 hour (assessed at study inclusion)
Behavioral performance during the fMRI: empathy reactivity
Empathy in response to empathy inducing pictures (rated on Likert scale)
Measured: 1 hour (assessed at study inclusion)
Behavioral performance during the fMRI: working memory
Working memory performance during fMRI
Measured: 1 hour (assessed at study inclusion)
Cognitive performance at study inclusion
Executive functions as assessed via computerized tests (CANTAB)
Measured: 1 hour (assessed at study inclusion)
Symptom improvement after 3 months: depression
Symptoms of depression will be assessed using validated clinical scales (e.g. BDI)
Measured: 3 months
Symptom improvement after 3 months: anxiety
Symptoms of generalized anxiety will be assessed using validated clinical scales (e.g. Penn State Worry Questionnaire)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study startJul 2016
- Primary completionDec 2018 (estimated)
- Study completionJun 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Provincial People's Hospital, The Fourth People's Hospital of Chengdu
- Responsible party
- Principal investigator, Benjamin Becker, University of Electronic Science and Technology of China
- Investigators
- Benjamin Becker, Dr., Principal investigator, School of Life Science and Technology, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084042
- Sponsor's protocol ID
- UESTC-neuSCAN-23
- Status last verified
- Oct 2018
- First submitted
- 24 Feb 2017
- Last updated
- 29 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 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Brain Networks & Cognitive Functioning in Depression and Anxiety
- ClinicalTrials.gov ID
- NCT03084042
- Acronym / sponsor ID
- UESTC-neuSCAN-23
- Keywords
- emotional impairments, cognitive impairments
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Collaborators
- Sichuan Provincial People's Hospital, The Fourth People's Hospital of Chengdu
- Study start
- Jul 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 20 Mar 2017 (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 study aims to 1) examine common and specific emotional and cognitive dysfunctions between Major Depression and generalized anxiety disorder; 2) Examine emotional and cognitive dysfunctions between the two disorders and healthy controls; 3) Examine the biomarkers predicting successful therapy or not.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Depression patients (MDD) | – | Device: fMRIPatients with diagnosis of major depression according to DSM criteria |
| Anxiety patients (GAD) | – | Device: fMRIPatients with generalized anxiety disorder according to DSM criteria |
| Healthy controls | – | Device: fMRIDemographically matched healthy controls. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients from the hospitals and healthy controls from community
Key inclusion criteria (6 listed)
- GAD:
- MDD:
Key exclusion criteria (2 listed)
- GAD: diagnosis of any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months
- MDD: diagnosis of any other psychiatric Axis I disorder (except MDD) as a principal diagnosis within the past six months
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 |
|---|---|---|
| fMRI | Device | Anxiety patients (GAD), Depression patients (MDD), Healthy controls |
Primary outcome
Brain activity in the emotional and cognitive core regions of the brain as assessed by fMRI
Time frame: 1 hour (assessed at study inclusion)
fMRI based indices during emotional face processing
Brain activity in the emotional and cognitive core regions of the brain as assessed by fMRI
Time frame: 1 hour (assessed at study inclusion)
fMRI based indices during empathy processing
Brain activity in the emotional and cognitive core regions of the brain as assessed by fMRI
Time frame: 1 hour (assessed at study inclusion)
fMRI based indices during working memory
6 secondary outcomes
Behavioral performance during the fMRI: face processing
Time frame: 1 hour (assessed at study inclusion)
Behavioral performance during the fMRI: empathy reactivity
Time frame: 1 hour (assessed at study inclusion)
Behavioral performance during the fMRI: working memory
Time frame: 1 hour (assessed at study inclusion)
Cognitive performance at study inclusion
Time frame: 1 hour (assessed at study inclusion)
Symptom improvement after 3 months: depression
Time frame: 3 months
Symptom improvement after 3 months: anxiety
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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.
Benjamin Becker, Dr. contact
Benjamin Becker, Dr. principal investigator
School of Life Science and Technology, University of Electronic Science and Technology of China
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 General Anxiety Disorder, 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 6 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 29 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 Benjamin Becker, Dr. (ben_becker@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity in the emotional and cognitive core regions of the brain as assessed by fMRI (time frame: 1 hour (assessed at study inclusion)). The study lists 3 primary outcomes in all. 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 29 Oct 2018.