A Phase 1 interventional study of ORM-12741 and Placebo in Healthy Volunteer, sponsored by University of Cape Town. Completed at 1 site in South Africa. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-10.
Sponsored by University of Cape Town · Phase 1, Interventional, and Basic science
The aim of the present study is to investigate changes in neural activity (BOLD signal), as measured using fMRI, in brain areas associated with emotional and working memory during task performance after single-dose administration of a novel selective alpha2c adrenoceptor antagonist (ORM-12741) in healthy volunteers. Further, it will be explored whether ORM-12741 affects connectivity between brain areas in rest, as measured using fMRI, and cognitive performance in the sample under investigation.
561 studies on the registry are indexed under Mood Disorders; 105 are open to participants now.
This study's enrollment of 68 is below the median of 80 across 419 interventional studies indexed under Mood Disorders.
Browse Mood Disorders studies →University of Cape Town is the lead sponsor of 116 studies on the registry; 14 are open to participants now.
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6 x 10 mg ORM-12741 immediate release capsules in a single dose
Drug: ORM-12741
1 x 10 mg ORM-12741 immediate release capsules and 5 x placebo capsules in a single dose
Drug: ORM-12741
6 x placebo capsules in a single dose
Drug: Placebo
Novel selective alpha2c adrenoceptor antagonist
Identical in appearance to experimental drug, not psycho-active
Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with emotional memory
Time frame: 1-1.5 hours post medication intake
Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with working memory
Time frame: 1-1.5 hours post medication intake
Effect of ORM-12741 on connectivity measures between brain areas as measured with BOLD signal in fMRI obtained in a resting state
Time frame: 1.5-2 hours post medication intake
Effect of ORM-12741 on memory task performance (as measured by accuracy and response latency)
Time frame: 1-3 hours post medication intake
Ran from Mar 2018 to primary completion in Dec 2018, 8 months.
Of 14 phase 1 interventional studies under Mood Disorders, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 59. This study's 8 months is below that.
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ORM-12741