SPECT Study With SB-773812 In Schizophrenic Patients
Status:
Completed
Trial end date:
2007-05-26
Target enrollment:
Participant gender:
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 stable plasma concentration (Cp) of SB-773812 will be investigated
using SPECT scan in up to 15 chronic schizophrenic patients in an open- label design. In
group 2 up to 80 patients will receive SB-773812 or Risperidone for 6 weeks to obtain at
least 10 patients showing clinical improvement with SB-773812. The relationship of D2 RO,
measured at steady state after chronic dosing at Cmax (6+/-2 h) and Ctrough (24+/-4 h), and
PK at steady state after repeated doses, to efficacy readouts will be investigated. The
SB-773812 dose administered will be selected as the highest dose proven to be safe and well
tolerated from a previous study.