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OpenTrials
Completed

NCT Number: NCT00392743

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pet/spect scan

Procedure

Primary outcomes

  1. PET and SPECT striatal binding potential

    Time frame: at day 1

Secondary outcomes

  1. plasma concentrations at the time of scanning,

    Time frame: at day 1

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 26, 2006
Registry last updated
Nov 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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