A Phase 1/2 interventional study of ARA290 and Placebo in Depression, sponsored by Leiden University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-25.
Sponsored by Leiden University Medical Center · Phase 1/2, Interventional, and Basic science
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.
SUMMARY Rationale: Studies on the cognitive and neuronal effects of a single administration of Erythropoietin (EPO) in healthy volunteers and in depressed patients have suggested that EPO may have antidepressant effects. Due to its haematopoietic effects, EPO may cause serious side-effects with repeated administration, which limits its usefulness as an antidepressant. ARA290 is a peptide that does not have the haematopoietic effects of EPO but may still have its neurotrophic effects.
Objective: To study the effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers 7 days post-administration.
Study design: Randomized double-blind placebo-controlled experiment. Study population: Male and female healthy volunteers, n= 36; 18-35 yr old. Intervention: One group receives a single dose of 2 mg ARA290, the other group receives placebo.
Main study parameters/endpoints:
Nature and extent of the burden and risks and benefits associated with participation:
Risks: No adverse events have been associated with the administration of a single dose of 70 -2000 μg ARA290 among 36 individuals, with the exception of one individual (with an undisclosed significant prior history of fainting) who fainted shortly after the intravenous dose administration of 700 μg ARA290 and recovered without medical intervention. Fourteen individuals have participated in a multiple dosing study with no serious adverse effects. Single doses of ARA290 in patients with renal impairment did not raise a safety signal.
Burden: Minimal. Emotional information processing test battery, burden comparable with playing computer games. fMRI measurement.
Benefits: Probably none. Possibly transient and small improvement of mood state. Financial compensation for participating.
8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 36 is below the median of 84 across 6,869 interventional studies indexed under Depression.
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Exclusion Criteria:
11-amino acid, linear peptide ARA290; intravenous injection with 2 mg ARA290 (single dosage).
Drug: ARA290
saline (NaCl 0.9%)
Drug: Placebo
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.
Time frame: 1 week
• Performance on a task of working memory
Time frame: 1 week
Neural response to angry faces
Neural processing of emotions, in particular amygdala, hippocampal and ventromedial prefrontal cortex (VMPFC) response to viewing facial stimuli expressing a negative or positive emotion.
Time frame: 1 week
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cibinetide
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