Emotional Brain Networks & Cognitive Functioning in Depression and Anxiety

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: Unknown
• Conditions: Major Depressive Disorder; General Anxiety Disorder
• Intervention / Treatment: Device: fMRI

• Study Type: Observational
• Enrollment (Anticipated): 105

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chendu, Sichuan, China, 611731
      • Recruiting
      • School of Life science and Technology, University of Electronic Science and Technology of China
      • Contact: Benjamin Becker, Dr.; Email: ben_becker@gmx.de

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Brain activity in the emotional and cognitive core regions of the brain as assessed by fMRI	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	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	fMRI based indices during working memory	1 hour (assessed at study inclusion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral performance during the fMRI: face processing	Accuracy during face processing	1 hour (assessed at study inclusion)
Behavioral performance during the fMRI: empathy reactivity	Empathy in response to empathy inducing pictures (rated on Likert scale)	1 hour (assessed at study inclusion)
Behavioral performance during the fMRI: working memory	Working memory performance during fMRI	1 hour (assessed at study inclusion)
Cognitive performance at study inclusion	Executive functions as assessed via computerized tests (CANTAB)	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)	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)	3 months

Collaborators and Investigators

• Sponsor: University of Electronic Science and Technology of China
• Collaborators: Sichuan Provincial People's Hospital; The Fourth People's Hospital of Chengdu

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: cognitive impairments; emotional impairments
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Depressive Disorder; Disease; Anxiety Disorders; Depressive Disorder, Major
• Other Study ID 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