Status:

COMPLETED

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

Lead Sponsor:

University of Cape Town

Collaborating Sponsors:

Orion Corporation, Orion Pharma

University of Oxford

Conditions:

Healthy Volunteer

Eligibility:

All Genders

18-30 years

Phase:

PHASE1

Brief Summary

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 aft...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

March 26 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 6 2018

Estimated Enrollment :

68 Patients enrolled

Trial Details

Trial ID

NCT03440021

Start Date

March 26 2018

End Date

December 6 2018

Last Update

January 10 2019

Active Locations (1)

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1

UCT Dept. Psychiatry & Mental Health / CUBIC

Cape Town, Western Cape, South Africa, 7925