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In-Patient Study In Schizophrenic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00197093
First Posted: September 20, 2005
Last Update Posted: May 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GlaxoSmithKline
September 13, 2005
September 20, 2005
May 18, 2009
September 2004
Not Provided
Safety and Tolerability of 773812 during 28 days of dosing. Pharmacokinetics of 773812 after repeat dosing.
Same as current
Complete list of historical versions of study NCT00197093 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
In-Patient Study In Schizophrenic Patients
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Schizophrenia
Drug: SB773812
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00197093
773812/003
Not Provided
Not Provided
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP