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Noradrenergic Activity, Cognition and Major Depressive Disorder (YohCog)

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: NCT02470026
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Linn Kuehl, PhD, Charite University, Berlin, Germany

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Early Life Trauma Drug: yohimbine Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Influences on Noradrenergic Activity for Cognition in Patients With Major Depressive Disorder
Study Start Date : June 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. behavioral responses in two different conditions of noradrenergic stimulation [ Time Frame: 2,5 hrs ]
    reaction times and error scores (computer tasks)

  2. physiological responses in two different conditions of noradrenergic stimulation [ Time Frame: 2,5 hrs ]
    physiological recordings, saliva samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470026


Locations
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Germany
Charite University
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
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Responsible Party: Linn Kuehl, PhD, PhD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02470026    
Other Study ID Numbers: KU3106/2-1
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Yohimbine
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents