Back to resultsIn-Patient Study In Schizophrenic Patients
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SB773812
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, safety, tolerability, pharmacokinetics
Eligibility 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.
Sites / Locations
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00197093
Brief Title
In-Patient Study In Schizophrenic Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, safety, tolerability, pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SB773812
Primary Outcome Measure Information:
Title
Safety and Tolerability of 773812 during 28 days of dosing. Pharmacokinetics of 773812 after repeat dosing.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
In-Patient Study In Schizophrenic Patients
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