Major Depressive DisorderYohCogNCT02470026
Noradrenergic Activity, Cognition and Major Depressive Disorder
A study testing yohimbine in people with Major Depressive Disorder and Early Life Trauma, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This study investigates influences of nordadrenergic activity on cognition in patients with major depression regarding influences of early life stress. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Early Life Trauma
- What is being tested?
- yohimbine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- diagnosis of major depression
- experience of early life trauma
Who cannot join
- severe illness
- Alzheimer´s
- schizophrenia
- bipolar disorder
- control group: - diagnosis of major depression/ experience of early life trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influences on Noradrenergic Activity for Cognition in Patients With Major Depressive Disorder
This study investigates influences of nordadrenergic activity on cognition in patients with major depression regarding influences of early life stress.
Read the 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
- Being tested
- yohimbine, placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yohimbineDrug
single low dose treatment
placeboDrug
single control treatment
| Study group | Role | What they receive |
|---|---|---|
| Yohimbine-Placebo | Experimental | single low dose treatment with yohimbine on test day 1, placebo on test day 2 Receives: Drug: yohimbine; Drug: placebo |
| Placebo-Yohimbin | Experimental | placebo on test day 1, single low dose treatment with yohimbine on test day 2 Receives: Drug: yohimbine; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
behavioral responses in two different conditions of noradrenergic stimulation
reaction times and error scores (computer tasks)
Measured: 2,5 hrs
physiological responses in two different conditions of noradrenergic stimulation
physiological recordings, saliva samples
Measured: 2,5 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJun 2014
- Primary completionNov 2017
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linn Kuehl, PhD, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470026
- Sponsor's protocol ID
- KU3106/2-1
- Acronym
- YohCog
- Status last verified
- May 2019
- First submitted
- 31 May 2015
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influences on Noradrenergic Activity for Cognition in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02470026
- Acronym / sponsor ID
- YohCog / KU3106/2-1
- Conditions
- Major Depressive Disorder, Early Life Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yohimbine-Placebo | Experimental | Drug: yohimbine, Drug: placebosingle low dose treatment with yohimbine on test day 1, placebo on test day 2 |
| Placebo-Yohimbin | Experimental | Drug: yohimbine, Drug: placeboplacebo on test day 1, single low dose treatment with yohimbine on test day 2 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- diagnosis of major depression
- experience of early life trauma
Key exclusion criteria (5 listed)
- severe illness
- Alzheimer´s
- schizophrenia
- bipolar disorder
- control group: - diagnosis of major depression/ experience of early life trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| yohimbinesingle low dose treatment | Drug | Placebo-Yohimbin, Yohimbine-Placebo |
| placebosingle control treatment | Drug | Placebo-Yohimbin, Yohimbine-Placebo |
Primary outcome
behavioral responses in two different conditions of noradrenergic stimulation
Time frame: 2,5 hrs
reaction times and error scores (computer tasks)
physiological responses in two different conditions of noradrenergic stimulation
Time frame: 2,5 hrs
physiological recordings, saliva samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yohimbine in people with Major Depressive Disorder and Early Life Trauma, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
behavioral responses in two different conditions of noradrenergic stimulation (time frame: 2,5 hrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019; AzTrials last refreshed its copy on 2 Nov 2026.