NCT00166322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 7, 2008

Status Verified

May 1, 2008

Enrollment Period

3.9 years

First QC Date

September 9, 2005

Last Update Submit

May 6, 2008

Conditions

Schizophrenia

Keywords

IBZM-SPECTAmphetamine ChallengeSchizophreniadopaminergic neurotransmissionPersons at risk for the development of schizophreniahealthy subjects

Outcome Measures

Primary Outcomes (1)

  • dopamine receptor availability

    cross-sectional

Interventions

IBZM-SPECT (bolus and constant infusion paradigm)PROCEDURE

single IBZM-SPECT assessment at study inclusion

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept. of Psychiatry

Munich, D-80336, Germany

Location

Dept. of Nuclear Medicine

Munich, D-81377, Germany

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Oliver Pogarell, MD

    Dept. of Psychiatry, University of Munich

    PRINCIPAL INVESTIGATOR

  • Klaus Tatsch, MD

    Dept. of Nuclear Medicine, University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

January 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

May 7, 2008

Record last verified: 2008-05

Locations

DE(2)