Effects of Aripiprazole and Haloperidol on Mesolimbic System Functioning
Arip_200901
1 other identifier
interventional
54
1 country
1
Brief Summary
The main objective is to investigate if the brain activation signature of a typical antipsychotic agent is dissociable from a newer drug with a pharmacological profile that differs from both typical and atypical antipsychotics since it is a potent partial D2 agonist. The method used to study this will be functional magnetic resonance imaging (fMRI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2010
CompletedFirst Posted
Study publicly available on registry
July 13, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedSeptember 12, 2014
September 1, 2014
10 months
July 8, 2010
September 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Differences in blood oxygen level dependent response after an acute dose of either aripiprazole or haloperidol in healthy controls
Differences in brain activity, especially in the ventral striatum and frontal cortex, will be measured using functional magnetic resonance imaging.
August 2010 - June 2011
Study Arms (3)
aripiprazole
ACTIVE COMPARATORhaloperidol
ACTIVE COMPARATORsuger pill
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or Female subject, 18 to 50 years of age
- Capacity to give written informed consent
- Psychiatrically healthy as determined by the MINI interview
You may not qualify if:
- History of head trauma resulting in loss of consciousness \>30 minutes that required medical attention
- Positive screen for pregnancy or current breast feeding
- Serious, unstable medical illness, or any concomitant major medical or neurological illness as determined by history and physical exam
- Used psychotropic medication in the last two years
- Used any drugs/medications/natural product the last two weeks (contraceptives, caffeine and nicotine excluded)
- Metal implants that would preclude an MRI scan
- Clinically relevant abnormalities in the electro-cardiogram (ECG)
- Confirmed clinically significant abnormal laboratory value(s) at screening (lab screen, LFTs, haematology and urine sample will be performed)
- Any history of arterial hypertension or paroxysmal hypertensive states
- Established diagnosis of advanced arteriosclerosis
- Established diagnosis of hyperthyroidism
- Established diagnosis of glaucoma
- History of hypersensitivity to sympathomimetic amines
- History of hypersensitivity to aspirin
- Self-reported feelings of claustrophobia when in narrow environments
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital, Ullevål
Oslo, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ole A Andreassen, MD, PhD
Oslo University Hospital, Ullevål
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2010
First Posted
July 13, 2010
Study Start
August 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
September 12, 2014
Record last verified: 2014-09