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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00392743

Collaborator

(none)

Enrollment

Locations

Duration (Months)

8.6

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Procedure: pet/spect scan

Study Design

Study Type:

Observational

Actual Enrollment :

60 participants

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

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
pet/spect scan	Procedure: pet/spect scan

Arm

Intervention/Treatment

pet/spect scan

Procedure: pet/spect scan

Outcome Measures

Primary Outcome Measures

PET and SPECT striatal binding potential [at day 1]

Secondary Outcome Measures

plasma concentrations at the time of scanning, [at day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	GSK Investigational Site	Barcelona	Spain	08003
2	GSK Investigational Site	Barcelona	Spain	08025
3	GSK Investigational Site	Barcelona	Spain	08035
4	GSK Investigational Site	Barcelona	Spain	08036
5	GSK Investigational Site	Barcelona	Spain
6	GSK Investigational Site	Espluges de Llobregat	Spain	08950
7	GSK Investigational Site	Sant Boi de Llobregat	Spain	08830