Schizophrenia
Conditions
Keywords
Schizophrenia, safety, tolerability, pharmacokinetics
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.
Interventions
DRUGSB773812
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability of 773812 during 28 days of dosing. Pharmacokinetics of 773812 after repeat dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Outcome results
None listed