Emotional Brain Networks & Cognitive Functioning in Depression and Anxiety

October 26, 2018 updated by: Benjamin Becker, University of Electronic Science and Technology of China
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Sichuan
      • Chendu, Sichuan, China, 611731
        • Recruiting
        • School of Life science and Technology, University of Electronic Science and Technology of China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from the hospitals and healthy controls from community

Description

Inclusion Criteria:

  • GAD:

    1. 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
    2. Duration of the current episode > 3 weeks

  • MDD:

    1. 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
    2. Duration of the current episode > 4 weeks

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Depression patients (MDD)
Patients with diagnosis of major depression according to DSM criteria
Device: fMRI
Anxiety patients (GAD)
Patients with generalized anxiety disorder according to DSM criteria
Device: fMRI
Healthy controls
Demographically matched healthy controls.
Device: fMRI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 hour (assessed at study inclusion)
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
1 hour (assessed at study inclusion)
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
1 hour (assessed at study inclusion)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavioral performance during the fMRI: face processing
Time Frame: 1 hour (assessed at study inclusion)
Accuracy during face processing
1 hour (assessed at study inclusion)
Behavioral performance during the fMRI: empathy reactivity
Time Frame: 1 hour (assessed at study inclusion)
Empathy in response to empathy inducing pictures (rated on Likert scale)
1 hour (assessed at study inclusion)
Behavioral performance during the fMRI: working memory
Time Frame: 1 hour (assessed at study inclusion)
Working memory performance during fMRI
1 hour (assessed at study inclusion)
Cognitive performance at study inclusion
Time Frame: 1 hour (assessed at study inclusion)
Executive functions as assessed via computerized tests (CANTAB)
1 hour (assessed at study inclusion)
Symptom improvement after 3 months: depression
Time Frame: 3 months
Symptoms of depression will be assessed using validated clinical scales (e.g. BDI)
3 months
Symptom improvement after 3 months: anxiety
Time Frame: 3 months
Symptoms of generalized anxiety will be assessed using validated clinical scales (e.g. Penn State Worry Questionnaire)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Electronic Science and Technology of China

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sichuan Provincial People's Hospital
The Fourth People's Hospital of Chengdu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UESTC-neuSCAN-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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