NCT02070783

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_1 depression

Timeline
Completed

Started Feb 2012

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

February 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

February 23, 2014

Last Update Submit

February 23, 2014

Conditions

Depression

Keywords

depressioncognitionemotion perceptioninformation processing

Outcome Measures

Primary Outcomes (1)

  • performance on information processing test battery, particularly emotion recognition

    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.

    1 week

Secondary Outcomes (1)

  • • Performance on a task of working memory

    1 week

Other Outcomes (1)

  • Neural response to angry faces

    1 week

Study Arms (2)

ARA290

EXPERIMENTAL

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

Drug: ARA290

Placebo

PLACEBO COMPARATOR

saline (NaCl 0.9%)

Drug: Placebo

Interventions

ARA290DRUG
ARA290
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Dutch-speaking
  • Age 18-35
  • Right-handedness
  • BMI 18 to 33 kg/m2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, Netherlands

Location

Related Publications (3)

  • Brines M, Cerami A. Erythropoietin-mediated tissue protection: reducing collateral damage from the primary injury response. J Intern Med. 2008 Nov;264(5):405-32. doi: 10.1111/j.1365-2796.2008.02024.x.

    PMID: 19017170BACKGROUND

  • Miskowiak KW, Vinberg M, Harmer CJ, Ehrenreich H, Kessing LV. Erythropoietin: a candidate treatment for mood symptoms and memory dysfunction in depression. Psychopharmacology (Berl). 2012 Feb;219(3):687-98. doi: 10.1007/s00213-011-2511-1. Epub 2011 Sep 23.

    PMID: 21947319BACKGROUND

  • Cerit H, Veer IM, Dahan A, Niesters M, Harmer CJ, Miskowiak KW, Rombouts SA, Van der Does W. Testing the antidepressant properties of the peptide ARA290 in a human neuropsychological model of drug action. Eur Neuropsychopharmacol. 2015 Dec;25(12):2289-99. doi: 10.1016/j.euroneuro.2015.09.005. Epub 2015 Sep 18.

    PMID: 26431906DERIVED

MeSH Terms

Conditions

Depression

Interventions

cibinetide

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Willem Van der Does, PhD

    Leiden University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

February 23, 2014

First Posted

February 25, 2014

Study Start

February 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2014

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations

NL(1)