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"We should keep in mind, important study limitations include the lack of a control group; pre/post design comparing historical data with data collected in the trials could create a bias due to the mismatch in settings; and patients may have had more frequent contact with treating physicians and investigators during the trial period which could favor the outcomes in the open-label phase. Therefore prospective studies should be conducted to confirm these findings," Dr. Janicak said.
A separate post-hoc analysis from those same three OLE studies also presented today examined employment status of patients with schizophrenia treated with paliperidone ER over the 52-week OLE period. A total of 1,012 patients 18 years and older with a diagnosis of schizophrenia were included. At their first and last visits, patients were placed into nine different occupational status categories.
The percentage of patients who reported employment during the open-label phase of the study increased throughout the 52-week study period. The number of patients who were employed full-time at their last visit almost doubled from 4.8 percent at the first visit to 8.8 percent, and the number of patients in any form of employment (including students, but excluding housewives or those retired) increased by 10.6 percent.
The studies were sponsored by Ortho-McNeil Janssen Scientific Affairs, LLC. Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. markets paliperidone ER in the U.S.
Paliperidone ER, an atypical antipsychotic medication, was first
approved in the U.S. in December
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