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Completed

NCT Number: NCT03440021

Single-dose Novel Selective alpha2c Antagonist Pharmaco-MRI Study in Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteer Behavior Behavioral Symptoms Mental Disorders Mood Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCT Dept. Psychiatry & Mental Health / CUBIC

Cape Town, Western Cape, 7925, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • good command of English language
  • right handedness
  • normal or corrected-to-normal vision

Exclusion criteria

  • personal history or active presence of psychiatric conditions
  • usage of psychotropic medication within the past 3 months
  • pregnancy or breast-feeding status
  • systolic blood pressure < 90 mmHg or > 140 mmHg at screening visit
  • diastolic blood pressure < 50 mmHg or > 90 mmHg at screening visit
  • resting heart rate < 45 beats/minute or > 100 beats/minute at screening visit
  • active presence of medical condition at physical examination
  • history of major traumatic brain injury
  • any other contraindication to MRI of the brain
  • use of psychoactive substances incl. alcohol in 24 hours prior to test session

Treatment and study plan

ORM-12741

Drug

Novel selective alpha2c adrenoceptor antagonist

Placebo

Drug

Identical in appearance to experimental drug, not psycho-active

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. Effect of ORM-12741 on memory task performance (as measured by accuracy and response latency)

    Time frame: 1-3 hours post medication intake

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Collaborators

  • Orion Corporation, Orion Pharma
  • University of Oxford

Registry information

Official study title

The Effects of Single-dose Administration of a Novel Selective alpha2c Antagonist on Emotional and Cognitive Processing in Healthy Volunteers: an fMRI Investigation

Acronym: SNAP_MRI

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2018
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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