SPECT Study With SB-773812 In Schizophrenic Patients

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00269035

Collaborator

(none)

Enrollment

Locations

Arms

23.1

Actual Duration (Months)

15.8

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: SB773812 Drug: Risperidone	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

A Parallel Study to Investigate Dopaminergic D2 and Serotoninergic 5HT2A Receptor Occupancy at Stable Plasma Concentrations of SB-773812 After Repeated Doses in Schizophrenic Patients. Relationship With Pharmacokinetics and Efficacy Readouts.

Actual Study Start Date :

Jun 21, 2005

Actual Primary Completion Date :

May 26, 2007

Actual Study Completion Date :

May 26, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group 1 Subjects in group 1 will receive SB-773812 tablet once daily till still steady Cp	Drug: SB773812 SB-773812 tablets will be available with dose strength of 60 mg
Experimental: Treatment Group 2 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	Drug: SB773812 SB-773812 tablets will be available with dose strength of 60 mg Drug: Risperidone Risperidone tablets will be available with dose strength of 3 and 6 mg

Arm

Intervention/Treatment

Experimental: Treatment Group 1

Subjects in group 1 will receive SB-773812 tablet once daily till still steady Cp

Drug: SB773812

SB-773812 tablets will be available with dose strength of 60 mg

Experimental: Treatment Group 2

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

Drug: SB773812

SB-773812 tablets will be available with dose strength of 60 mg

Drug: Risperidone

Risperidone tablets will be available with dose strength of 3 and 6 mg

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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
5	GSK Investigational Site	Sant Boi de Llobregat	Spain	08830
6	GSK Investigational Site	Vic (Barcelona)	Spain	08500