To study the effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers 7 days post-administration.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Accuracy and speed to recognize facial expressions of emotions
• Number of positive personal descriptions recalled in a memory task
• Decision making as assessed with computerized social cognitive tests
• Neural processing of emotions, in particular amygdala, hippocampal and
ventromedial prefrontal cortex (VMPFC) response to viewing facial stimuli
expressing a negative or positive emotion.
• Functional brain connectivity of brain regions expected to be affected:
amygdala and VMPFC.
Secondary outcome
• Accuracy and response time to identify targets in the presence of emotional
distractor words.
• Performance on a task of working memory.
• Speed of information processing and attentional shifting.
• Performance on a moral reasoning task.
• Subjective mood states
Background summary
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.
Study 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.
Intervention
One group receives a single dose of 2 mg ARA290, the other group receives
placebo.
Study burden and risks
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.
Wassenaarseweg 52
2333 AK Leiden
NL
Wassenaarseweg 52
2333 AK Leiden
NL
Listed location countries
Age
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, as determined by a MINI International Neuropsychiatric Interview (MINI), 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-024364-18-NL |
| CCMO | NL35265.058.11 |