ClinicalTrials.gov
ClinicalTrials.gov Menu

Dopaminergic Neurotransmission in Schizophrenia, Patients at Risk and Healthy Subjects

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.
ClinicalTrials.gov Identifier: NCT00166322
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : May 7, 2008
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich

Brief Summary:
This study is an investigation of the dopaminergic neurotransmission in patients with schizophrenia, patients at risk for the development of schizophrenia, and healthy controls using an iodobenzamide-single photon emission computed tomography (IBZM-SPECT) imaging technique under amphetamine challenge.

Condition or disease Intervention/treatment Phase
Schizophrenia Procedure: IBZM-SPECT (bolus and constant infusion paradigm) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : January 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources


Intervention Details:
    Procedure: IBZM-SPECT (bolus and constant infusion paradigm)
    single IBZM-SPECT assessment at study inclusion


Primary Outcome Measures :
  1. dopamine receptor availability [ Time Frame: cross-sectional ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of schizophrenia (currently unmedicated)
  • Subjects at risk for the development of schizophrenia (prodromal symptoms)
  • Healthy subjects
  • Written informed consent

Exclusion Criteria:

  • Neurological or severe somatic disorders
  • Women during pregnancy or lactation
  • Occupational exposition to radiation > 15mSv
  • Medication known to interfere with IBZM
  • Contraindications for the use of amphetamine challenge

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 ClinicalTrials.gov identifier (NCT number): NCT00166322


Locations
Germany
Dept. of Psychiatry
Munich, Germany, D-80336
Dept. of Nuclear Medicine
Munich, Germany, D-81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Oliver Pogarell, MD Dept. of Psychiatry, University of Munich
Principal Investigator: Klaus Tatsch, MD Dept. of Nuclear Medicine, University of Munich

Responsible Party: O. Pogarell, MD, University of Munich
ClinicalTrials.gov Identifier: NCT00166322     History of Changes
Other Study ID Numbers: DYN-SPECT-Pogarell
EK076/03
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: May 2008

Keywords provided by Ludwig-Maximilians - University of Munich:
IBZM-SPECT
Amphetamine Challenge
Schizophrenia
dopaminergic neurotransmission
Persons at risk for the development of schizophrenia
healthy subjects

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Dopamine
Dopamine Agents
Dopamine Agonists
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents