NCT03084042

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

2.4 years

First QC Date

February 24, 2017

Last Update Submit

October 26, 2018

Conditions

Major Depressive DisorderGeneral Anxiety Disorder

Keywords

emotional impairmentscognitive impairments

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Behavioral performance during the fMRI: face processing

    1 hour (assessed at study inclusion)

  • Behavioral performance during the fMRI: empathy reactivity

    1 hour (assessed at study inclusion)

  • Behavioral performance during the fMRI: working memory

    1 hour (assessed at study inclusion)

  • Cognitive performance at study inclusion

    1 hour (assessed at study inclusion)

  • Symptom improvement after 3 months: depression

    3 months

  • +1 more secondary outcomes

Study Arms (3)

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

Interventions

fMRIDEVICE
Anxiety patients (GAD)Depression patients (MDD)Healthy controls

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients from the hospitals and healthy controls from community

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Life Science and Technology, University of Electronic Science and Technology of China

Chengdu, Sichuan, 611731, China

RECRUITING

Biospecimen

Retention: NONE RETAINED

saliva

MeSH Terms

Conditions

Depressive Disorder, MajorGeneralized Anxiety DisorderCognitive Dysfunction

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersAnxiety DisordersCognition DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Benjamin Becker, Dr.

    School of Life Science and Technology, University of Electronic Science and Technology of China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Becker, Dr.

CONTACT

ben_becker@gmx.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 20, 2017

Study Start

July 1, 2016

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

October 29, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)