A Placebo Controlled, Double-Blind, Randomised Study Investigating the Safety, Tolerability and Pharmacokinetics of Ascending Multiple Oral Doses of SB-773812 in Male and Female Schizophrenic Patients for up to 28 Days

GlaxoSmithKline0 sites60 target enrollmentSeptember 2004

ConditionsSchizophrenia

DrugsSB773812

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: GlaxoSmithKline
Enrollment: 60
Primary Endpoint: Safety and Tolerability of 773812 during 28 days of dosing. Pharmacokinetics of 773812 after repeat dosing.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study is a placebo-controlled study to assess the safety and tolerability of a novel antipsychotic medication, (773812) when given to schizophrenic patients for twenty-eight days. Assessments include blood sampling to determine drug concentrations, psychiatric assessments while under treatment, and movement assessments to evaluate potential side effects.

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

TBD

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

•Must have schizophrenia that has been stable for at least three months.
•Willing to discontinue current anti-psychotic medications (under supervision) prior to the study.
•Willing to live at the study center for a total of 38 days and then return for three follow-up visits.

Exclusion Criteria

•Taking medications for conditions other than schizophrenia.
•History of alcohol or drug abuse within six months of the study, and their alcohol consumption must meet moderate guidelines.

Outcomes

Primary Outcomes

Safety and Tolerability of 773812 during 28 days of dosing. Pharmacokinetics of 773812 after repeat dosing.

Secondary Outcomes

Assessment of (1) changes in testing scores on a range of psychiatric assessments (PANSS, BPRS. CGI) (2) psychometric performance and (3)body weight/ girth measurement /glucose and lipd measurement, each as a function of duration of dosing.