NEW YORK (Reuters Health) Sep 15 – Adjunctive armodafinil, the longer-lasting isomer of modafinil, doesn’t improve cognitive deficits in patients with schizophrenia, researchers report in an August 24th online paper in the Journal of Clinical Psychiatry.
Dr. John M. Kane, of The Zucker Hillside Hospital in Glen Oaks, New York, and colleagues randomized 60 patients (mean age 43 years) with stable schizophrenia to adjunctive treatment with once-daily placebo or armodafinil 50, 100, or 200 mg.
Fifteen patients were assigned to each group; 49 (82%) completed the 4-week study. Changes in cognitive deficits from baseline to the final visit were similar following armodafinil or placebo, as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) composite score. Mean changes ranged from 1.9 with 50 mg to 2.9 with 200 mg; scores in the placebo group fell in the middle.
In two previous trials, modafinil-treated patients didn’t differ from placebo-treated patients in the Scale for the Assessment of Negative Symptoms (SANS) scores. Similarly, in the current study, there were no clinically meaningful reductions in the SANS total score.
Armodafinil was generally well tolerated. The most common adverse events were diarrhea and headache. Treatment did not cause psychosis to worsen.
Patients who received armodafinil 200 mg did have greater improvement in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) than those who received placebo, but the results were not statistically significant.
The mechanism of action of armodafinil is not known. “A weak DAT (dopamine transporter) inhibitor such as armodafinil, which may preferentially influence the dopaminergic activity in the prefrontal cortex but not in the limbic system, could, hypothetically, reduce negative symptoms without worsening positive symptoms–the effect suggested in this study,” Dr. Kane and colleagues write.
They also say that “treating negative symptoms of schizophrenia is important because these symptoms are debilitating for patients and because antipsychotic therapies are often not adequate to treat them.”
Their conclusion is that more study is needed to determine the potential efficacy of modafinil on negative symptoms.
The study was sponsored by Cephalon, the manufacturer of armodafinil, which either employs or has financial relationships with all the paper’s seven authors.
Reuters Health Information
Submitted by Anna