Back to resultsSPECT Study With SB-773812 In Schizophrenic Patients
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
SB773812
Risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring SB-773812, SPECT, D2 RO, pharmacokinetics, schizophrenic patients, 5HT2A RO
Eligibility Criteria
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.
Sites / Locations
- 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 2
Arm Type
Experimental
Experimental
Arm Label
Treatment Group 1
Treatment Group 2
Arm Description
Subjects in group 1 will receive SB-773812 tablet once daily till still steady Cp
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
Outcomes
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)
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00269035
Brief Title
SPECT Study With SB-773812 In Schizophrenic Patients
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 21, 2005 (Actual)
Primary Completion Date
May 26, 2007 (Actual)
Study Completion Date
May 26, 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
SB-773812, SPECT, D2 RO, pharmacokinetics, schizophrenic patients, 5HT2A RO
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group 1
Arm Type
Experimental
Arm Description
Subjects in group 1 will receive SB-773812 tablet once daily till still steady Cp
Arm Title
Treatment Group 2
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
SB773812
Intervention Description
SB-773812 tablets will be available with dose strength of 60 mg
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
Risperidone tablets will be available with dose strength of 3 and 6 mg
Primary Outcome Measure Information:
Title
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)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
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).
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Mataro (Barcelona)
Country
Spain
Facility Name
GSK Investigational Site
City
Sant Boi de Llobregat
ZIP/Postal Code
08830
Country
Spain
Facility Name
GSK Investigational Site
City
Vic (Barcelona)
ZIP/Postal Code
08500
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
SPECT Study With SB-773812 In Schizophrenic Patients
We'll reach out to this number within 24 hrs