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

NCT ID: NCT00392743

Last Updated: 2012-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Bolus 11C-Raclopride Schizophrenia 123I-IBZM SPECT Receptor Occupancy PET MRI Antipsychotics Bolus/Infusion

Study Groups

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pet/spect scan

pet/spect scan

Intervention Type PROCEDURE

Interventions

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pet/spect scan

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Espluges de Llobregat, , Spain

Site Status

GSK Investigational Site

Sant Boi de Llobregat, , Spain

Site Status

Countries

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Spain

Other Identifiers

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TMT108154

Identifier Type: -

Identifier Source: org_study_id