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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00392743
Enrollment
60
Registered
2006-10-26
Start date
2006-12-31
Completion date
2007-05-31
Last updated
2012-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

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

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.

Interventions

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
PET and SPECT striatal binding potentialat day 1

Secondary

MeasureTime frame
plasma concentrations at the time of scanning,at day 1

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026