Emotional Brain Networks & Cognitive Functioning in Depression and Anxiety

Major Depressive Disorder Clinical Trial

Official title:

Emotional Brain Networks & Cognitive Functioning in Depression and Anxiety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03084042
• Other study ID #: UESTC-neuSCAN-23
• Status: Recruiting
• Start date: July 2016
• Est. completion date: June 2019

Study information

• Verified date: October 2018
• Source: University of Electronic Science and Technology of China
• Contact: Benjamin Becker, Dr.
• Email: ben_becker[@]gmx.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• General Anxiety Disorder
• Major Depressive Disorder

Intervention

Device:
• fMRI

Locations

Country	Name	City	State
China	School of Life Science and Technology, University of Electronic Science and Technology of China	Chendu	Sichuan

Sponsors (3)

Lead Sponsor	Collaborator
University of Electronic Science and Technology of China	Sichuan Provincial People's Hospital, The Fourth People's Hospital of Chengdu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Behavioral performance during the fMRI: face processing	Accuracy during face processing	1 hour (assessed at study inclusion)
Secondary	Behavioral performance during the fMRI: empathy reactivity	Empathy in response to empathy inducing pictures (rated on Likert scale)	1 hour (assessed at study inclusion)
Secondary	Behavioral performance during the fMRI: working memory	Working memory performance during fMRI	1 hour (assessed at study inclusion)
Secondary	Cognitive performance at study inclusion	Executive functions as assessed via computerized tests (CANTAB)	1 hour (assessed at study inclusion)
Secondary	Symptom improvement after 3 months: depression	Symptoms of depression will be assessed using validated clinical scales (e.g. BDI)	3 months
Secondary	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