Flexible-dose injection treatment shows promise for schizophrenia

Intramuscular (IM) paliperidone palmitate given in flexible doses can be helpful for schizophrenics who have been unresponsive to oral antipsychotics, according to research from an international study.

In the first large trial that examined how the drug behaves in a "realistic setting," researchers found that the injectable treatment was safe and well-tolerated.

Acute and maintenance treatment

The study included 212 patients with acute schizophrenia who received once-monthly treatments of the drug. All of the patients had experienced unsuccessful outcomes with oral antipsychotics. At the end of the study, more than half of the patients were rated as only "normal to mildly" ill, Medscpe News reports. Scores on the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression-Severity scale also improved.

The drug, which is a long-acting antipsychotic, has been approved for treating both patients with acute schizophrenia and those who need maintenance medication.

The authors note that past studies on the drug have included fixed doses on patients that did not represent a diverse population.

"Pivotal trials usually rely on very select patient populations, but we felt it was critical for us to see how the drug behaves and performs in a more realistic setting," said Ludger Hargarter, European Medical Affairs Director for Psychiatry at Janssen Cilag in Neuss, Germany. "And this is really one of the first big interventional studies to look at these acute patients in a naturalistic setting."

Other outcomes

Researchers found that 66.7 percent of the study participants had the desired treatment response, with outcomes improving by as early as week two. They also reported a "highly significant mean improvement" in patients after six months.

"This suggests that there might be a real benefit if this drug is used early in the hospital stay," said Hargarter.

The most common side effects were injection site pain, insomnia, headache and anxiety. The participants also gained an average of about six pounds over the course of the study.

Source: Medscape

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