NCT03440021

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 26, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2018

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

February 13, 2018

Last Update Submit

January 9, 2019

Conditions

Healthy Volunteer

Keywords

Noradrenalin AgentsPhysiological Effects of DrugsMood disordersBehavioral Symptoms

Outcome Measures

Primary Outcomes (2)

  • Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with emotional memory

    1-1.5 hours post medication intake

  • 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 Outcomes (2)

  • 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

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

    1-3 hours post medication intake

Study Arms (3)

High-dosage (60mg) ORM-12741

EXPERIMENTAL

6 x 10 mg ORM-12741 immediate release capsules in a single dose

Drug: ORM-12741

Low-dosage (10mg) ORM-12741

EXPERIMENTAL

1 x 10 mg ORM-12741 immediate release capsules and 5 x placebo capsules in a single dose

Drug: ORM-12741

Placebo

PLACEBO COMPARATOR

6 x placebo capsules in a single dose

Drug: Placebo

Interventions

ORM-12741DRUG

Novel selective alpha2c adrenoceptor antagonist

High-dosage (60mg) ORM-12741Low-dosage (10mg) ORM-12741
PlaceboDRUG

Identical in appearance to experimental drug, not psycho-active

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCT Dept. Psychiatry & Mental Health / CUBIC

Cape Town, Western Cape, 7925, South Africa

Location

MeSH Terms

Conditions

Mood DisordersBehavioral Symptoms

Interventions

ORM-12741

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Study Officials

  • Dan J. Stein, MD, PhD

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: High-dosage (60mg), Low-dosage (10mg), Placebo
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 20, 2018

Study Start

March 26, 2018

Primary Completion

December 5, 2018

Study Completion

December 6, 2018

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

ZA(1)