Clinical trial NCT03084042: Emotional Brain Networks & Cognitive Functioning in Depression and Anxiety
Official title: Emotional Brain Networks & Cognitive Functioning in Depression and Anxiety
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Depressive Disorder
General Anxiety Disorder
Keywords: emotional impairments
cognitive impairments
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
Collaborators: name: Sichuan Provincial People's Hospital
name: The Fourth People's Hospital of Chengdu
First posted: 2017-03-20
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the hospitals and healthy controls from community

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Brain activity in the emotional and cognitive core regions of the brain as assessed by fMRI
timeFrame: 1 hour (assessed at study inclusion)
measure: Brain activity in the emotional and cognitive core regions of the brain as assessed by fMRI
timeFrame: 1 hour (assessed at study inclusion)
measure: Brain activity in the emotional and cognitive core regions of the brain as assessed by fMRI
timeFrame: 1 hour (assessed at study inclusion)
Secondary outcomes:
measure: Behavioral performance during the fMRI: face processing
timeFrame: 1 hour (assessed at study inclusion)
measure: Behavioral performance during the fMRI: empathy reactivity
timeFrame: 1 hour (assessed at study inclusion)
measure: Behavioral performance during the fMRI: working memory
timeFrame: 1 hour (assessed at study inclusion)
measure: Cognitive performance at study inclusion
timeFrame: 1 hour (assessed at study inclusion)
measure: Symptom improvement after 3 months: depression
timeFrame: 3 months
measure: Symptom improvement after 3 months: anxiety
timeFrame: 3 months
Other outcomes:
Locations:
city: Chendu
country: China
facility: School of Life Science and Technology, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: School of Life Science and Technology, University of Electronic Science and Technology of China
name: Benjamin Becker, Dr.
role: PRINCIPAL_INVESTIGATOR
References: