We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00392743
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : November 5, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Schizophrenia Procedure: pet/spect scan

Study Design

Study Type : Observational
Actual Enrollment : 60 participants
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
Study Start Date : December 2006
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392743


Locations
Spain
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00392743     History of Changes
Other Study ID Numbers: TMT108154
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: November 5, 2012
Last Verified: October 2012

Keywords provided by GlaxoSmithKline:
Bolus
11C-Raclopride
Schizophrenia
123I-IBZM
SPECT
Receptor Occupancy
PET
MRI
Antipsychotics
Bolus/Infusion

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs