A Study to Compare Two Different Brain Imaging Techniques in Healthy Volunteers and in Schizophrenic Patients

November 1, 2012 updated by: GlaxoSmithKline

An Open-label, Cross-over Study, to Compare the PET and SPECT Measurement of Antipsychotic-induced D2 Receptor Occupancy, in a Group of Healthy Volunteers and in Another Group of Patients With Schizophrenia and Other Psychotic Disorders

A direct comparison of Positron Emission Tomography (PET) (11C-Raclopride) and Single Photon Emission Computed Tomography (SPECT) (123I-IBZM) D2 RO measurements would allow GSK to gain understanding on the SPECT results obtained with SB773812, and to accurately interpret future D2 RO results from either PET or SPECT studies with new compounds.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • GSK Investigational Site
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Barcelona, Spain, 08003
        • GSK Investigational Site
      • Barcelona, Spain
        • GSK Investigational Site
      • Espluges de Llobregat, Spain, 08950
        • GSK Investigational Site
      • Sant Boi de Llobregat, Spain, 08830
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a methodology study.

Description

Inclusion criteria:

  • Not pregnant or becoming pregnant during the study.
  • No abnormality in clinical examination, clinical laboratory test or ECG.
  • Not taking drugs
  • Patients with schizophrenia, schizophreniform disorder or schizoaffective disorders.
  • Patients with at least 1 month antipsychotic monotherapy with either risperidone, olanzapine or clozapine.
  • Healthy volunteers with no neurological or psychiatric illness.

Exclusion criteria:

  • Have received other antipsychotic during the last month or neuroleptics during the last year.
  • If you have taken part in investigations you should not receive a radiation dose of more than 10 mSv over any 3 year period.
  • History of bleeding disorder or are taking medication that affects blood clotting
  • History of substance dependence (except nicotine)
  • Claustrophobia
  • Gross head deformity.
  • Unable to lie still in the PET or SPECT camera for 1 hour and a half.
  • The presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pet/spect scan
Procedure: pet/spect scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PET and SPECT striatal binding potential
Time Frame: at day 1
at day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
plasma concentrations at the time of scanning,
Time Frame: at day 1
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

October 24, 2006

First Submitted That Met QC Criteria

October 24, 2006

First Posted (Estimate)

October 26, 2006

Study Record Updates

Last Update Posted (Estimate)

November 4, 2012

Last Update Submitted That Met QC Criteria

November 1, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMT108154

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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