NCT00269035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P75+ for phase_1 schizophrenia

Timeline
Completed

Started Jun 2005

Typical duration for phase_1 schizophrenia

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2007

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

December 21, 2005

Last Update Submit

August 15, 2017

Conditions

Schizophrenia

Keywords

SB-773812SPECTD2 ROpharmacokineticsschizophrenic patients5HT2A RO

Outcome Measures

Primary Outcomes (1)

  • 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)

    6 weeks

Secondary Outcomes (1)

  • 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).

    6 weeks

Study Arms (2)

Treatment Group 1

EXPERIMENTAL

Subjects in group 1 will receive SB-773812 tablet once daily till still steady Cp

Drug: SB773812

Treatment Group 2

EXPERIMENTAL

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: SB773812Drug: Risperidone

Interventions

SB773812DRUG

SB-773812 tablets will be available with dose strength of 60 mg

Treatment Group 1Treatment Group 2
RisperidoneDRUG

Risperidone tablets will be available with dose strength of 3 and 6 mg

Treatment Group 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

GSK Investigational Site

Barcelona, 08003, Spain

Location

GSK Investigational Site

Barcelona, 08025, Spain

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Mataro (Barcelona), Spain

Location

GSK Investigational Site

Sant Boi de Llobregat, 08830, Spain

Location

GSK Investigational Site

Vic (Barcelona), 08500, Spain

Location

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 23, 2005

Study Start

June 21, 2005

Primary Completion

May 26, 2007

Study Completion

May 26, 2007

Last Updated

August 17, 2017

Record last verified: 2017-08

Locations

ES(6)