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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB773812

Drug

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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start: 2004
First posted: Sep 20, 2005
Registry last updated: May 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed