Last updated: 11/04/2018 04:12:29
SPECT Study With SB-773812 In Schizophrenic Patients
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
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)
Timeframe: 6 weeks
Secondary outcomes:
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).
Timeframe: 6 weeks
Interventions:
Drug: SB773812
Drug: Risperidone
Enrollment:
95
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Schizophrenia
Product
SB773812
Collaborators
Not applicable
Study date(s)
June 2005 to May 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
No
- schizophrenic patients as diagnosed by DSM IV criteria.
- Subject shows severe exacerbation, extreme instability, high risk for suicide or serious violent behaviour.
- Any clinically or laboratory significant abnormality.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Sant Boi de Llobregat, Spain, 08830
Status
Will Be Recruiting
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-26-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study 773812/007 can be found on the GSK Clinical Study Register.
Click hereAccess to clinical trial data by researchers
Visit website