In-Patient Study In Schizophrenic Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197093
First received: September 13, 2005
Last updated: May 15, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: SB773812
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Safety and Tolerability of 773812 during 28 days of dosing. Pharmacokinetics of 773812 after repeat dosing.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 60
Study Start Date: September 2004
Intervention Details:
    Drug: SB773812
    Other Name: SB773812
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197093

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00197093     History of Changes
Other Study ID Numbers: 773812/003
Study First Received: September 13, 2005
Last Updated: May 15, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Schizophrenia
safety
tolerability
pharmacokinetics

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014