SPECT Study With SB-773812 In Schizophrenic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-21

Study Completion Date

2007-05-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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Treatment Group 1

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

Group Type EXPERIMENTAL

SB773812

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

SB773812

Intervention Type DRUG

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

Risperidone

Intervention Type DRUG

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

Interventions

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SB773812

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

Intervention Type DRUG

Risperidone

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No