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
1 other identifier
observational
60
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2006
Shorter than P25 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2006
CompletedFirst Posted
Study publicly available on registry
October 26, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedNovember 5, 2012
October 1, 2012
5 months
October 24, 2006
November 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PET and SPECT striatal binding potential
at day 1
Secondary Outcomes (1)
plasma concentrations at the time of scanning,
at day 1
Study Arms (1)
pet/spect scan
Interventions
Eligibility Criteria
This is a methodology study.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (7)
GSK Investigational Site
Barcelona, 08003, Spain
GSK Investigational Site
Barcelona, 08025, Spain
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Espluges de Llobregat, 08950, Spain
GSK Investigational Site
Sant Boi de Llobregat, 08830, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2006
First Posted
October 26, 2006
Study Start
December 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
November 5, 2012
Record last verified: 2012-10