Noradrenergic Activity, Cognition and Major Depressive Disorder

Not Applicable

Completed

• Conditions: Major Depressive Disorder; Early Life Trauma
• Interventions: Drug: yohimbine; Drug: placebo

• Registration Number: NCT02470026
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-05-31
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-12
• Primary Completion: 2017-11
• Study Completion: 2018-10
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Yohimbine-Placebo	placebo	single low dose treatment with yohimbine on test day 1, placebo on test day 2
Placebo-Yohimbin	placebo	placebo on test day 1, single low dose treatment with yohimbine on test day 2
Yohimbine-Placebo	yohimbine	single low dose treatment with yohimbine on test day 1, placebo on test day 2
Placebo-Yohimbin	yohimbine	placebo on test day 1, single low dose treatment with yohimbine on test day 2

Primary Outcome Measures

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

Trial Locations

Locations (1)

Charite University; 🇩🇪 Berlin, Germany