Status:
COMPLETED
SPECT Study With SB-773812 In Schizophrenic Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study is being conducted in 2 groups of schizophrenic patients: in group 1 the relationship between the dopaminergic D2 receptor occupancy (D2 RO ) and serotoninergic 5HT2A receptor occupancy at ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- schizophrenic patients as diagnosed by DSM IV criteria.
- In group 2, subject has schizophrenia or schizophreniform disorder and show moderate disease exacerbation, a PANSS score \> 65 and a score in the PANSS positive scale (PANSS-P) =25.
- Women of childbearing potential must agree to acceptable method of birth control.
- Exclusion criteria:
- Subject shows severe exacerbation, extreme instability, high risk for suicide or serious violent behaviour.
- Any clinically or laboratory significant abnormality.
- Subjects receiving a radiation dose from other activities of more than 10 mSv over any 3 year period.
- Subjects with organic brain disease and history of severe head trauma.
- Heart pacemaker, metallic prosthesis or other metallic body implants.
- Significant head deformity.
- Smokers with associated COPD.
- History or presence of clinically significant gastro-intestinal, hepatic or renal disease.
- History of cholecystectomy or biliary tract disease.
- Positive for HBV, HCV or HIV.
- Pregnant or lactating women.
Exclusion
Key Trial Info
Start Date :
June 21 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2007
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00269035
Start Date
June 21 2005
End Date
May 26 2007
Last Update
August 17 2017
Active Locations (6)
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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
Mataro (Barcelona), Spain