Effects of Aripiprazole and Haloperidol on Mesolimbic System Functioning

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01161277
• Date of registration: 08/07/2010
• Primary sponsor: Oslo University Hospital
• Public title: Effects of Aripiprazole and Haloperidol on Mesolimbic System Functioning Arip_200901
• Scientific title: Effects of Aripiprazole and Haloperidol on Mesolimbic System Functioning: A Pharmacological fMRI Study
• Date of first enrolment: August 2010
• Target sample size: 54
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01161277
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Countries of recruitment

Norway

Contacts

• Name: Ole A Andreassen, MD, PhD
• Affiliation: Oslo University Hospital, Ullevål

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or Female subject, 18 to 50 years of age

- Capacity to give written informed consent

- Psychiatrically healthy as determined by the MINI interview

Exclusion Criteria:

- 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

- Worked with metal as a grinder, welder etc.

- Lifetime history of substance dependence or abuse (except nicotine and caffeine)

- Systolic blood pressure > 140 and/or Diastolic blood pressure >90

- Body weight below 56kg or above 94kg

- History of use of antipsychotic medication



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Psychosis

Schizophrenia

Intervention(s)

Drug: Aripiprazole

Drug: Haloperidol

Drug: Placebo sugar pill

Primary Outcome(s)

Differences in blood oxygen level dependent response after an acute dose of either aripiprazole or haloperidol in healthy controls [Time Frame: August 2010 - June 2011]

Secondary ID(s)

2009-016222-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors