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
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.