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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01161277
First received: July 8, 2010
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Psychosis
Schizophrenia
Drug: Aripiprazole
Drug: Haloperidol
Drug: Placebo sugar pill
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effects of Aripiprazole and Haloperidol on Mesolimbic System Functioning: A Pharmacological fMRI Study

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Differences in brain activity, especially in the ventral striatum and frontal cortex, will be measured using functional magnetic resonance imaging.


Enrollment: 54
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161277

Locations
Norway
Oslo University Hospital, Ullevål
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Ole A Andreassen, MD, PhD Oslo University Hospital, Ullevål
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01161277     History of Changes
Other Study ID Numbers: 2009-016222-14
Study First Received: July 8, 2010
Last Updated: September 11, 2014
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Aripiprazole
Haloperidol
Ventral striatum
Reward
fMRI

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Haloperidol
Haloperidol decanoate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on September 22, 2014