Skip to main content
OpenTrials
Completed

NCT Number: NCT02658617

Functional Neuroanatomy and Regional Metabolism Before and After Treatment With Duloxetine

The findings may guide future investigations on novel therapeutic targets in depressive subjects. Based on the depicted link between personality traits and altered brain metabolism and function, the latter might be used as supporting objective measures and possible biomarkers for increased depression risk.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

Interoceptive awareness (IA) is the awareness of bodily signals and has been highlighted as important in many early theories of emotion. William James was one of the first to present a psychological theory linking viscero-afferent feedback to emotional experience. The processing of bodily and thus interoceptive stimuli may be a crucial component in yielding empathy, since affective states are often assumed to involve awareness of one´s own bodily state. The assumption of a close relationship between interceptive awareness and empathy is further supported when considering the regions recruited during both processes, like the insula and the anterior cingulate cortex. Although especially the affective component may implicate interoception and interoceptive awareness, the impact of interoception on empathy has never been evaluated behaviorally or neurophysiologically.

Also associated with altered insula and anterior cingulate cortex (ACC) function is Alexithymia. Alexithymia, a personality trait, is marked by cognitive and affective features including difficulties in identifying and describing feelings as well as in distinguishing feelings from bodily sensations of emotional arousal. Recent studies found a negative correlation between prefrontal glutamate (Glu) and mental perspective taking as well as extraversion. Even though several functional imaging studies investigated the neuronal signatures of interoceptive awareness and the personality trait alexithymia, little is known about the functional relevance of neurotransmitter concentrations

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • acute depressive episode

Exclusion criteria

  • major medical illness
  • history of seizures, head trauma with loss of consciousness
  • abnormal clinical laboratory test result, and pregnancy
  • atypical forms of depression
  • suicidal ideation
  • any additional psychiatric disorder
  • history of substance abuse or dependence
  • electroconvulsive therapy in the previous 6 months

Healthy subjects without any psychiatric, neurologic, or medical illness

Treatment and study plan

Primary outcomes

  1. Changes in brain activation patterns after 6 weeks treatment with duloxetine

    Time frame: up to 2 months

Sponsors and collaborators

Lead sponsor

Heinz Boeker

Other

Registry information

Official study title

Functional Neuroanatomy and Regional Metabolism Before and After Treatment With Duloxetine: A Combined fMRI and MRS Study in Major Depression

Important dates

Study start
2010
Primary completion
2010
Study completion
2015
First posted
Jan 20, 2016
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.