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Effects of Aripiprazole and Haloperidol on Mesolimbic System Functioning (Arip_200901)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01161277
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : September 12, 2014
Information provided by (Responsible Party):
Oslo University Hospital

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).

Condition or disease Intervention/treatment Phase
Psychosis Schizophrenia Drug: Aripiprazole Drug: Haloperidol Drug: Placebo sugar pill Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effects of Aripiprazole and Haloperidol on Mesolimbic System Functioning: A Pharmacological fMRI Study
Study Start Date : August 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: aripiprazole Drug: Aripiprazole
Dose: 5-10 mg depending on subject weight
Other Name: Abilify

Active Comparator: haloperidol Drug: Haloperidol
Dose: 1-2 mg depending on subject weight
Other Name: Haldol

Placebo Comparator: suger pill Drug: Placebo sugar pill
Dose: 1-2 pills depending on subject weight

Primary Outcome Measures :
  1. 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 ]
    Differences in brain activity, especially in the ventral striatum and frontal cortex, will be measured using functional magnetic resonance imaging.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01161277

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Oslo University Hospital, Ullevål
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
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Principal Investigator: Ole A Andreassen, MD, PhD Oslo University Hospital, Ullevål
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Responsible Party: Oslo University Hospital Identifier: NCT01161277    
Other Study ID Numbers: 2009-016222-14
First Posted: July 13, 2010    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014
Keywords provided by Oslo University Hospital:
Ventral striatum
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Haloperidol decanoate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Anti-Dyskinesia Agents