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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: October 24, 2006
Last updated: November 1, 2012
Last verified: October 2012
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.

Condition Intervention
Procedure: pet/spect scan

Study Type: Observational
Official Title: 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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • PET and SPECT striatal binding potential [ Time Frame: at day 1 ]

Secondary Outcome Measures:
  • plasma concentrations at the time of scanning, [ Time Frame: at day 1 ]

Enrollment: 60
Study Start Date: December 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
pet/spect scan Procedure: pet/spect scan


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This is a methodology study.

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.
  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 identifier: NCT00392743

GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Espluges de Llobregat, Spain, 08950
GSK Investigational Site
Sant Boi de Llobregat, Spain, 08830
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00392743     History of Changes
Other Study ID Numbers: TMT108154
Study First Received: October 24, 2006
Last Updated: November 1, 2012

Keywords provided by GlaxoSmithKline:
Receptor Occupancy

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on April 24, 2017