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Dopaminergic Neurotransmission in Schizophrenia, Patients at Risk and Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00166322
First received: September 9, 2005
Last updated: May 6, 2008
Last verified: May 2008
  Purpose

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 Intervention
Schizophrenia
Procedure: IBZM-SPECT (bolus and constant infusion paradigm)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • dopamine receptor availability [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: January 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: IBZM-SPECT (bolus and constant infusion paradigm)
    single IBZM-SPECT assessment at study inclusion
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  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: NCT00166322

Locations
Germany
Dept. of Nuclear Medicine
Munich, Germany, D-81377
Dept. of Psychiatry
Munich, Germany, D-80336
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
  More Information

No publications provided

Responsible Party: O. Pogarell, MD, University of Munich
ClinicalTrials.gov Identifier: NCT00166322     History of Changes
Other Study ID Numbers: DYN-SPECT-Pogarell, EK076/03
Study First Received: September 9, 2005
Last Updated: May 6, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014