A Study to Compare Two Different Brain Imaging Techniques in Healthy Volunteers and in Schizophrenic Patients - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00392743

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	Phase
Schizophrenia Schizophreniform Disorder Schizoaffective Disorder	Procedure: pet/spect scan	Phase I

MedlinePlus related topics: Nuclear Scans Psychotic Disorders Schizophrenia

Drug Information available for: Raclopride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study
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

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 ]

Estimated Enrollment:	60
Study Start Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 Clinical Trials Call Center
Barcelona, Spain, 08003
GSK Clinical Trials Call Center
Barcelona, Spain, 08035
GSK Clinical Trials Call Center
Barcelona, Spain, 08830
GSK Clinical Trials Call Center
Barcelona, Spain, 08025
GSK Clinical Trials Call Center
Barcelona, Spain, 08036
GSK Clinical Trials Call Center
Barcelona, Spain, 08950

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Study ID Numbers:	TMT108154
Study First Received:	October 24, 2006
Last Updated:	August 27, 2007
ClinicalTrials.gov Identifier:	NCT00392743
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by GlaxoSmithKline:

Antipsychotics
Schizophrenia
Bolus
Bolus/Infusion
MRI

PET
Receptor Occupancy
11C-Raclopride
123I-IBZM
SPECT

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Raclopride

Psychotic Disorders
Healthy
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 14, 2009