COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional Neuroanatomy and Regional Metabolism Before and After Treatment With Duloxetine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658617
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Heinz Boeker, University of Zurich

Brief Summary:
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.

Condition or disease
Depression

Detailed Description:

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

Layout table for study information
Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Neuroanatomy and Regional Metabolism Before and After Treatment With Duloxetine: A Combined fMRI and MRS Study in Major Depression
Study Start Date : March 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Duloxetine

Group/Cohort
patients
20 patients were enrolled. Subjects were investigated with magnetic resonance spectroscopy (MRS), functional magnetic resonance imaging (fMRI) and also underwent a psychodiagnostic assessment (evaluating the severity of depression: Hamilton Depression Rating Scale and Beck Depression Inventory; measuring hopelessness: Beck Hopelessness Scale; measuring Alexithymia: Toronto Alexithymia Scale; measuring self-perception: Body Perception Questionnaire). 1-2 days after the imaging patients started the treatment with duloxetine: 30mg for the first three days, then 60-90mg.
healthy controls
Subjects were investigated with magnetic resonance spectroscopy (MRS), functional magnetic resonance imaging (fMRI) and also underwent a psychodiagnostic assessment (evaluating the severity of depression: Hamilton Depression Rating Scale and Beck Depression Inventory; measuring hopelessness: Beck Hopelessness Scale; measuring Alexithymia: Toronto Alexithymia Scale; measuring self-perception: Body Perception Questionnaire).



Primary Outcome Measures :
  1. Changes in brain activation patterns after 6 weeks treatment with duloxetine [ Time Frame: up to 2 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with an acute depressive episode (n = 20; 10 females; mean age ± SD age, 32.2 ± 10.3 years; number of episodes 2.7 ± 1.9; age of onset 26.7 ± 9.1 years) were recruited from the inpatient department of psychiatry at the University of Zurich. All patients were either medication naïve or not on any psychotropic medication for at least 6 weeks prior to study enrollment. Participants were entered into the study after a full explanation of the purpose of the study and the study procedures and after written consent was obtained as approved by the University of Zurich's institutional review board.
Criteria

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

Layout table for additonal information
Responsible Party: Heinz Boeker, Prof. Dr. med., University of Zurich
ClinicalTrials.gov Identifier: NCT02658617    
Other Study ID Numbers: PUK09
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by Heinz Boeker, University of Zurich:
Empathy
Interoceptive Awareness
fMRI
MRS
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms