In-Patient Study In Schizophrenic Patients

Phase 1

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00197093
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-15
• Last Update Posted: 2009-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.