YohCog: Noradrenergic Activity, Cognition and Major Depressive Disorder

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT02470026

Collaborator

(none)

131

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Jun 1, 2014

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Oct 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

behavioral responses in two different conditions of noradrenergic stimulation [2,5 hrs]
reaction times and error scores (computer tasks)
physiological responses in two different conditions of noradrenergic stimulation [2,5 hrs]
physiological recordings, saliva samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charite University	Berlin		Germany

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Linn Kuehl, PhD, PhD, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT02470026

Other Study ID Numbers:

KU3106/2-1

First Posted:

Jun 12, 2015

Last Update Posted:

May 23, 2019

Last Verified:

May 1, 2019

Additional relevant MeSH terms:

Depressive Disorder

Depression

Depressive Disorder, Major

Yohimbine

Study Results

No Results Posted as of May 23, 2019