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

Healthy Volunteer Clinical Trial

— SNAP_MRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03440021
• Other study ID #: 069/2017
• Secondary ID: N2/19/8/2DOH-27-
• Status: Completed
• Phase: Phase 1
• Start date: March 26, 2018
• Est. completion date: December 6, 2018

Study information

• Verified date: January 2019
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 6, 2018
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• ORM-12741
Novel selective alpha2c adrenoceptor antagonist
• Placebo
Identical in appearance to experimental drug, not psycho-active

Locations

Country	Name	City	State
South Africa	UCT Dept. Psychiatry & Mental Health / CUBIC	Cape Town	Western Cape

Sponsors (3)

Lead Sponsor	Collaborator
University of Cape Town	Orion Corporation, Orion Pharma, University of Oxford

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with emotional memory		1-1.5 hours post medication intake
Primary	Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with working memory		1-1.5 hours post medication intake
Secondary	Effect of ORM-12741 on connectivity measures between brain areas as measured with BOLD signal in fMRI obtained in a resting state		1.5-2 hours post medication intake
Secondary	Effect of ORM-12741 on memory task performance (as measured by accuracy and response latency)		1-3 hours post medication intake