Back to resultsA Study to Compare Two Different Brain Imaging Techniques in Healthy Volunteers and in Schizophrenic Patients
Primary Purpose
Schizophrenia
Status
Completed
Phase
Locations
Spain
Study Type
Observational
Intervention
pet/spect scan
Sponsored by
About this trial
This is an observational trial for Schizophrenia focused on measuring Bolus, 11C-Raclopride, Schizophrenia, 123I-IBZM, SPECT, Receptor Occupancy, PET, MRI, Antipsychotics, Bolus/Infusion
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Arm Label
pet/spect scan
Arm Description
Outcomes
Primary Outcome Measures
PET and SPECT striatal binding potential
Secondary Outcome Measures
plasma concentrations at the time of scanning,
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00392743
Brief Title
A Study to Compare Two Different Brain Imaging Techniques in Healthy Volunteers and in Schizophrenic Patients
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 Type
Observational
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Bolus, 11C-Raclopride, Schizophrenia, 123I-IBZM, SPECT, Receptor Occupancy, PET, MRI, Antipsychotics, Bolus/Infusion
7. Study Design
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pet/spect scan
Intervention Type
Procedure
Intervention Name(s)
pet/spect scan
Primary Outcome Measure Information:
Title
PET and SPECT striatal binding potential
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
plasma concentrations at the time of scanning,
Time Frame
at day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Study Population Description
This is a methodology study.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
Country
Spain
Facility Name
GSK Investigational Site
City
Espluges de Llobregat
ZIP/Postal Code
08950
Country
Spain
Facility Name
GSK Investigational Site
City
Sant Boi de Llobregat
ZIP/Postal Code
08830
Country
Spain
12. IPD Sharing Statement
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A Study to Compare Two Different Brain Imaging Techniques in Healthy Volunteers and in Schizophrenic Patients
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