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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.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00392743
First received: October 24, 2006
Last updated: November 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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
Schizophrenia
 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:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • PET and SPECT striatal binding potential [ Time Frame: at day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • plasma concentrations at the time of scanning, [ Time Frame: at day 1 ] [ Designated as safety issue: No ]

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
Other Name: pet/spect scan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392743

Locations
Spain
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Barcelona, Spain, 08025
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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00392743     History of Changes
Other Study ID Numbers: TMT108154
Study First Received: October 24, 2006
Last Updated: November 1, 2012
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013