NCT02470026

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

3.4 years

First QC Date

May 31, 2015

Last Update Submit

May 21, 2019

Conditions

Major Depressive DisorderEarly Life Trauma

Outcome Measures

Primary Outcomes (2)

  • behavioral responses in two different conditions of noradrenergic stimulation

    reaction times and error scores (computer tasks)

    2,5 hrs

  • physiological responses in two different conditions of noradrenergic stimulation

    physiological recordings, saliva samples

    2,5 hrs

Study Arms (2)

Yohimbine-Placebo

EXPERIMENTAL

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

Drug: yohimbineDrug: placebo

Placebo-Yohimbin

EXPERIMENTAL

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

Drug: yohimbineDrug: placebo

Interventions

yohimbineDRUG

single low dose treatment

Placebo-YohimbinYohimbine-Placebo
placeboDRUG

single control treatment

Placebo-YohimbinYohimbine-Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of major depression
  • experience of early life trauma

You may not qualify if:

  • severe illness
  • Alzheimer´s
  • schizophrenia
  • bipolar disorder
  • control group: - diagnosis of major depression/ experience of early life trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University

Berlin, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Yohimbine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 31, 2015

First Posted

June 12, 2015

Study Start

June 1, 2014

Primary Completion

November 1, 2017

Study Completion

October 1, 2018

Last Updated

May 23, 2019

Record last verified: 2019-05

Locations

DE(1)