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SPECT Study With SB-773812 In Schizophrenic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00269035
First Posted: December 23, 2005
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 Drug: Risperidone Phase 1

Study Type: Interventional
Study Design: 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.

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
Actual Study Start Date: June 21, 2005
Study Completion Date: May 26, 2007
Primary Completion Date: May 26, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269035


Locations
Spain
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 08035
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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00269035     History of Changes
Other Study ID Numbers: 773812/007
First Submitted: December 21, 2005
First Posted: December 23, 2005
Last Update Posted: August 17, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
SB-773812
SPECT
D2 RO
pharmacokinetics
schizophrenic patients
5HT2A RO

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents