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Trial · Interventional

CompletedPhase 1/2Registry data

Cognitive and Neural Effects of ARA290

Short name CONEARA

NCTNCT02070783 (opens ClinicalTrials.gov in a new tab)Other id2010-024364-18
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
36 participants (actual)
Sponsor
Leiden University Medical Center · Other
Design
Randomized · Triple masking
Countries
1 country

Netherlands

Start
Feb 2012
Primary completion
Feb 2013
Completion
Feb 2014
First posted
25 Feb 2014 (estimated)
Last update posted
25 Feb 2014 (estimated)
Conditions
Depression

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. Ph 1/2

    CONEARA

    NCT02070783

    Feb 2012 to Feb 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Studies on the hormone Erythropoietin (EPO) have indicated that EPO may have antidepressant properties. However, EPO may cause serious side-effects with repeated administration (thrombosis), which limits its usefulness as an antidepressant. ARA290 is a peptide that does not have the effects of EPO on blood cells but may still have its effect on brain function. In an attempt to replicate previous findings with (a single dose of) EPO in healthy volunteers, we study the effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers. We hypothesize that a single dose of ARA290 will lead to a positive shift in information processing compared to placebo, 7 days post-administration.

Interventions

  • ARA290Drug
  • PlaceboDrug

Arms2

  • Experimental

    ARA290

    11-amino acid, linear peptide ARA290; intravenous injection with 2 mg ARA290 (single dosage).

  • Placebo comparator

    Placebo

    saline (NaCl 0.9%)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. performance on information processing test battery, particularly emotion recognition

    Time frame · 1 week

    Registry description

    Performance on an Emotional Test battery (ETB) which has been shown sensitive to antidepressant administration in healthy volunteers. The ETB includes a measure of facial expression recognition, emotional memory and attentional vigilance.

Secondary outcomes(1)

  1. • Performance on a task of working memory

    Time frame · 1 week

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

7 results

Testing the antidepressant properties of the peptide ARA290 in a human neuropsychological model of drug action.

Cerit et al. 2015European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacologycited by 9

PMID 26431906DOI 10.1016/j.euroneuro.2015.09.005PUB-26431906

Full text at the publisher7 results
Publisher pageSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 35 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Dutch-speaking * Age 18-35 * Right-handedness * BMI 18 to 33 kg/m2 Exclusion Criteria: * Major physical illness, such as diabetes, thyroid disease, epilepsy, stroke, multiple sclerosis, pituitary disease, or any other serious medical condition. * Any current or past psychiatric disorder, including subclinical claustrophobia if severe enough to cause anxiety during scanning. * Using medication likely to interfere with the study, including OTC (over the counter) medication (e.g., St John's Wort) and benzodiazepines. * Pregnancy or breastfeeding * Use of any nicotine products or soft drugs (hash, marihuana) in the three months prior to the study * Any hard drug use (including XTC) (lifetime) * Alcohol use of more than 14 units per week or more than 4 units on any day during the week prior to the study or during the study period.

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