SPECT Study With SB-773812 In Schizophrenic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00269035
First received: December 21, 2005
Last updated: September 13, 2012
Last verified: September 2012
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014