Use of atypical antipsychotic plus divalproex significantly improves recovery from an acute psychotic episode of schizophrenia

The combination of either olanzapine or risperidone with divalproex significantly improves and speeds recovery from an acute psychotic episode of schizophrenia, according to study results published in the January issue of Neuropsychopharmacology.

"Our findings suggest that combination therapy with divalproex can decrease the mental pain and suffering for many patients with schizophrenia and shorten the time they need to be in the hospital," said study leader Daniel E. Casey, M.D.

The American team studied 249 patients between the ages of 18 and 65 years who were hospitalized with an acute psychotic episode of schizophrenia. Patients who also had mood symptoms were excluded from the trial. Of the total, 65 were randomized to olanzapine, 66 to olanzapine plus divalproex, 60 to risperidone alone, and 58 tp risperidone plus divalproex.

Divalproex is an effective treatment for mood disorders, seizures, and migraine headache. Researchers found long ago that the drug was ineffective as a single agent treatment for schizophrenia. However, about 10 percent of patients with schizophrenia also have mood-disorder symptoms, and divalproex is often used empirically for this population in combination with antipsychotics. The current study was the first large-scale trial to evaluate whether divalproex in combination with an antipsychotic agent is effective against acute psychosis.

When compared with patients treated with either antipsychotic drug alone, patients treated with combination therapy showed an enhanced reduction of symptoms as early as the third day of therapy. Furthermore, the combination therapy was as well tolerated as either antipsychotic drug used alone, with no additional side effects.

Patients were treated for 28 days and evaluated at 3, 5, 7, 10, 14, 21, and 28 days with the Positive and Negative Syndrome Scale total score, a common psychiatric diagnostic tool used to measure changes in patient behavior. Improvements from baseline scores were observed throughout the treatment period in all four groups.

"At day 3 we were already seeing significant enhancement of benefits in the combination groups," Casey said. Clinical improvement, defined as a 20 percent or greater improvement from baseline scores, was seen in 53 percent of patients in the combination groups on day 7, but the same degree of improvement was not achieved until day 14 in the groups treated with either antipsychotic drug alone. A 20 percent improvement in symptoms is commonly used as a threshold to determine that a patient is ready to leave the hospital, Casey pointed out, "so for many patients the combination therapy has the potential to cut in half the time they have to spend in the hospital."

Both combination and single-drug therapy were well tolerated. Adverse effects and rates of discontinued therapy were similar among all treatment groups.

About 25 to 30 percent of schizophrenia patients respond poorly to antipsychotic drug therapy. Casey suggested that potential benefits of longer combination therapy in these patients should to be explored, as well as whether the enhanced improvements of combination therapy observed in the study would be sustained, increased, or diminished over longer periods of follow-up.


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