search
Back to results

Noradrenergic Activity, Cognition and Major Depressive Disorder (YohCog)

Primary Purpose

Major Depressive Disorder, Early Life Trauma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
yohimbine
placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Charite University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Yohimbine-Placebo

Placebo-Yohimbin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 31, 2015
Last Updated
May 21, 2019
Sponsor
Charite University, Berlin, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT02470026
Brief Title
Noradrenergic Activity, Cognition and Major Depressive Disorder
Acronym
YohCog
Official Title
Influences on Noradrenergic Activity for Cognition in Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Early Life Trauma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yohimbine-Placebo
Arm Type
Experimental
Arm Description
single low dose treatment with yohimbine on test day 1, placebo on test day 2
Arm Title
Placebo-Yohimbin
Arm Type
Experimental
Arm Description
placebo on test day 1, single low dose treatment with yohimbine on test day 2
Intervention Type
Drug
Intervention Name(s)
yohimbine
Intervention Description
single low dose treatment
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
single control treatment
Primary Outcome Measure Information:
Title
behavioral responses in two different conditions of noradrenergic stimulation
Description
reaction times and error scores (computer tasks)
Time Frame
2,5 hrs
Title
physiological responses in two different conditions of noradrenergic stimulation
Description
physiological recordings, saliva samples
Time Frame
2,5 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Charite University
City
Berlin
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Noradrenergic Activity, Cognition and Major Depressive Disorder

We'll reach out to this number within 24 hrs