In-Patient Study In Schizophrenic Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- Safety and Tolerability of 773812 during 28 days of dosing. Pharmacokinetics of 773812 after repeat dosing.
- 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.
|Study Start Date:||September 2004|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197093
|Study Director:||GSK Clinical Trials, MD||GlaxoSmithKline|