Noradrenergic Activity, Cognition and Major Depressive Disorder (YohCog)

May 21, 2019 updated by: Linn Kuehl, PhD, Charite University, Berlin, Germany

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charité University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yohimbine-Placebo
single low dose treatment with yohimbine on test day 1, placebo on test day 2
Drug: yohimbine
single low dose treatment
Drug: placebo
single control treatment
Experimental: Placebo-Yohimbin
placebo on test day 1, single low dose treatment with yohimbine on test day 2
Drug: yohimbine
single low dose treatment
Drug: placebo
single control treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
behavioral responses in two different conditions of noradrenergic stimulation
Time Frame: 2,5 hrs
reaction times and error scores (computer tasks)
2,5 hrs
physiological responses in two different conditions of noradrenergic stimulation
Time Frame: 2,5 hrs
physiological recordings, saliva samples
2,5 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

May 31, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KU3106/2-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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