Noradrenergic Activity, Cognition and Major Depressive Disorder

NCT ID: NCT02470026

Last Updated: 2019-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-10-31

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.

Conditions

Major Depressive Disorder; Early Life Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Yohimbine-Placebo

single low dose treatment with yohimbine on test day 1, placebo on test day 2

Group Type: EXPERIMENTAL

yohimbine

Intervention Type: DRUG

single low dose treatment

placebo

Intervention Type: DRUG

single control treatment

Placebo-Yohimbin

placebo on test day 1, single low dose treatment with yohimbine on test day 2

Group Type: EXPERIMENTAL

yohimbine

Intervention Type: DRUG

single low dose treatment

placebo

Intervention Type: DRUG

single control treatment

Interventions

yohimbine

single low dose treatment

Intervention Type: DRUG

placebo

single control treatment

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Linn Kuehl, PhD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charite University

Berlin, , Germany

Countries

Germany

Other Identifiers

KU3106/2-1

Identifier Type: -

Identifier Source: org_study_id