Patients were 18-65 years old and met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, criteria of schizophrenia for at least one year). The mean age of patients who entered was 35.8 years old.
Treatment in the OLE phase was initiated at a dose of 9mg/day with changes in dose increments of 3mg/day, to a maximum of 15mg/day or minimum of 3mg/day permitted.
Sixty percent of patients completed the OLE. TEAEs occurred in 69 percent of patients. The discontinuation rate due to adverse effects was 6 percent (n=12). TEAEs that occurred with an incidence of 8 percent or more were tremor (13 percent; n=31), akathisia (11 percent; n=25), headache (8 percent; n=19), and insomnia (8 percent; n=18).
Safety for INVEGA was evaluated from OLE baseline to end point, in the
context of a systematic review of TEAEs, clinical laboratory tests, body
weight and body mass index, electrocardiograms and EPS incidence using the
Simpson Angus Rating Scale, Barnes Akathisia Rating Scale and Abnormal
Involuntary Movement Scale. Efficacy was evaluated as a secondary endpoint
using the total PANSS score, with a negative score indicating a worsening
The mean changes observed in the total PANSS were:
* -15.7 +/- 20.09 for patients who had been treated with placebo during
DB, and who were then started on INVEGA during the OLE:
* -6.3 +/- 18.91 for those initially assigned to INVEGA during DB, and
then continued on INVEGA during the OLE; and
* -3.9 +/- 13.85 for those 83 patients who had previously
|SOURCE Johnson & Johnson|
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