Noradrenergic Activity, Cognition and Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— YohCog  

Official title:

Influences on Noradrenergic Activity for Cognition in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470026
• Other study ID #: KU3106/2-1
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: October 2018

Study information

• Verified date: May 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates influences of nordadrenergic activity on cognition in patients with major depression regarding influences of early life stress.

Description:

Stress plays a major role in the development and maintenance of major depression disorder. Indeed, various studies demonstrated maladaptive changes in physiological stress regulation systems of depressive patients, i.e. in the hypothalamus-pituitary-adrenal axis and the locus coeruleus-noradrenergic system. On a central level, changes of the locus coeruleus-noradrenergic system have been demonstrated.This seems to be the case especially in depressive patients with early life traumata. Comparable to the hypothalamus-pituitary-adrenal axis, the locus coeruleus-noradrenergic system influences not only the physiological stress response, but has also central influence with effects on cognitive functions. Indeed, noradrenergic effects on cognitive functions such as attention, learning and memory have been demonstrated in healthy individuals. Even though deficits in cognitive domains are core symptoms of major depression, the relationship of the noradrenergic system and cognitive processes has rarely been investigated so far.

In this project, the investigators will examine noradrenergic influences via administration of the alpha2-receptor blocker yohimbine on cognitive and emotionally relevant processes in depressive patients and controls. Additionally, the investigators will examine the influence of early life traumata on these relationships. Thus, the investigators will examine participants with and without major depression and with and without early life stress.

Results of this study will improve the understanding of cognitive dysfunctions associated with the noradrenergic system in patients with major depression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: October 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• diagnosis of major depression

• experience of early life trauma

Exclusion Criteria:

• severe illness

• Alzheimer´s

• schizophrenia

• bipolar disorder

• control group: - diagnosis of major depression/ experience of early life trauma

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Early Life Trauma
• Major Depressive Disorder

Intervention

Drug:
• yohimbine
single low dose treatment
• placebo
single control treatment

Locations

Country	Name	City	State
Germany	Charite University	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	behavioral responses in two different conditions of noradrenergic stimulation	reaction times and error scores (computer tasks)	2,5 hrs
Primary	physiological responses in two different conditions of noradrenergic stimulation	physiological recordings, saliva samples	2,5 hrs