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Dopaminergic Neurotransmission in Schizophrenia, Patients at Risk and Healthy Subjects

Primary Purpose

Schizophrenia

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

IBZM-SPECT (bolus and constant infusion paradigm)

About this trial

This is an interventional diagnostic trial for Schizophrenia focused on measuring IBZM-SPECT, Amphetamine Challenge, Schizophrenia, dopaminergic neurotransmission, Persons at risk for the development of schizophrenia, healthy subjects

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Dept. of Psychiatry
Dept. of Nuclear Medicine

Outcomes

Primary Outcome Measures

dopamine receptor availability

Secondary Outcome Measures

Full Information

NCT ID

NCT00166322

First Posted

September 9, 2005

Last Updated

May 6, 2008

Sponsor

Ludwig-Maximilians - University of Munich

1. Study Identification

Unique Protocol Identification Number

NCT00166322

Brief Title

Dopaminergic Neurotransmission in Schizophrenia, Patients at Risk and Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Ludwig-Maximilians - University of Munich

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

IBZM-SPECT, Amphetamine Challenge, Schizophrenia, dopaminergic neurotransmission, Persons at risk for the development of schizophrenia, healthy subjects

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

IBZM-SPECT (bolus and constant infusion paradigm)

Intervention Description

single IBZM-SPECT assessment at study inclusion

Primary Outcome Measure Information:

Title

dopamine receptor availability

Time Frame

cross-sectional

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oliver Pogarell, MD

Organizational Affiliation

Dept. of Psychiatry, University of Munich

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Klaus Tatsch, MD

Organizational Affiliation

Dept. of Nuclear Medicine, University of Munich

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept. of Psychiatry

City

Munich

ZIP/Postal Code

D-80336

Country

Germany

Facility Name

Dept. of Nuclear Medicine

City

Munich

ZIP/Postal Code

D-81377

Country

Germany

12. IPD Sharing Statement

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Dopaminergic Neurotransmission in Schizophrenia, Patients at Risk and Healthy Subjects

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