SPECT Study With SB-773812 In Schizophrenic Patients
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00269035
First received: December 21, 2005
Last updated: September 13, 2012
Last verified: September 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: SB773812 (risperidone) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Single Blind 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. |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
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) [ Time Frame: 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). [ Time Frame: 6 weeks ]
| Enrollment: | 95 |
| Study Start Date: | June 2005 |
Intervention Details:
-
Drug: SB773812 (risperidone)
Other Name: SB773812 (risperidone)
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269035
Locations
| Spain | |
| GSK Investigational Site | |
| Barcelona, Spain, 08035 | |
| GSK Investigational Site | |
| Barcelona, Spain, 08025 | |
| GSK Investigational Site | |
| Barcelona, Spain, 08003 | |
| GSK Investigational Site | |
| Mataro (Barcelona), Spain | |
| GSK Investigational Site | |
| Sant Boi de Llobregat, Spain, 08830 | |
| GSK Investigational Site | |
| Vic (Barcelona), Spain, 08500 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00269035 History of Changes |
| Other Study ID Numbers: | 773812/007 |
| Study First Received: | December 21, 2005 |
| Last Updated: | September 13, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by GlaxoSmithKline:
|
SB-773812 SPECT D2 RO |
pharmacokinetics schizophrenic patients 5HT2A RO |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 23, 2013