SPECT Study With SB-773812 In Schizophrenic Patients

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: SB773812; Drug: Risperidone

• Registration Number: NCT00269035
• Lead Sponsor: GlaxoSmithKline

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-21
• Study First Submitted: 2005-12-21
• Study First Submitted QC: 2005-12-22
• Study First Posted: 2005-12-23
• Primary Completion: 2007-05-26
• Study Completion: 2007-05-26
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	SB773812	Subjects in group 1 will receive SB-773812 tablet once daily till still steady Cp
Treatment Group 2	SB773812	Subjects in group 2 will receive SB-773812 tablets once daily over 6 weeks. Risperidone tablets 6 mg once daily from Days 1-7 two tablets of 3 mg and days 8 until stable Cp 6 mg tablets
Treatment Group 2	Risperidone	Subjects in group 2 will receive SB-773812 tablets once daily over 6 weeks. Risperidone tablets 6 mg once daily from Days 1-7 two tablets of 3 mg and days 8 until stable Cp 6 mg tablets

Primary Outcome Measures

Name	Time	Method
To investigate in schizophrenic patients the relationship between D2 RO, 5HT2A RO and stable plasma concentrations of SB-773812 (gr.1) and the relationship of D2 RO and PK over time at steady state to efficacy readouts after 6 w treatment (gr.2)	6 weeks

Secondary Outcome Measures

Name	Time	Method
To assess the effect of 6 week treatment of SB-773812 on clinical symptoms as measured by Positive and Negative Symptoms Scale (PANSS), cognitive performance and CGI Severity and Improvement as a function of duration of dosing (group 2).	6 weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Vic (Barcelona), Spain