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Older Adults With Treatment-Resistant Depression Respond to Risperidone: Presented at ECNP

By Paula Moyer

AMSTERDAM, THE NETHERLANDS -- October 31, 2005 -- Most older patients with depression who have not responded to other treatments appear to benefit from augmentation of citalopram (Celexa) with risperidone (Risperdal), according to findings presented here October 25^th at the 18^th Congress of the European College of Neuropsychopharmacology (ECNP).

"In a group of older patients who had [not responded to] at least 2 antidepressant trials in the current episode, 68% achieved symptom resolution," said principal investigator Georges Gharabawi, MD, an investigator with CNS Medical Affairs at Janssen Pharmaceutica in Titusville, New Jersey. "Approximately 40% showed a sustained benefit throughout the augmentation period."

The investigators were interested in whether risperidone augmentation of citalopram would be effective in older patients with chronic medical conditions, because such patients often do not respond to antidepressant therapies.

The researchers evaluated 101 patients who were at least 55 years old and had major depressive disorder, and had not achieved a benefit from at least 1 trial of an antidepressant in the current depressive episode. The subjects were part of a larger study, Augmentation with Risperidone in Resistant Depression (ARISe-RD).

In the open-label phase, the patients received citalopram monotherapy consisting of 20 to 40 mg daily for 4 to 6 weeks to confirm the lack of a response, defined as < 50% reduction in Hamilton Rating for Depression scale (HAM-D) scores. A full nonresponse was defined < 25% reduction in HAM-D scores.

Subjects averaged 63.4 years of age and 58% were women. They had had the current episode of depression for an average of 2.1 years. Of these subjects, 61% had received 2 or more antidepressants during the current episode.

After receiving augmentation with risperidone for 4 to 6 subsequent weeks, consisting of 0.25 to 1 mg daily, those who achieved symptomatic remission then entered a 24-week, double-blind maintenance phase, during which they receive citalopram augmented with either risperidone or placebo. Remission was defined as a HAM-D of no more than 7 or a Clinical Global Impression -- Severity (CGI-S) score of 1 or 2.

Of the 101 patients who completed the citalopram monotherapy phase, 93 had a no response. Of these, 89 completed the open-label risperidone augmentation phase, of whom 63 (70.8%) achieved remission and entered the 6-month, double-blind maintenance phase.

Median time to relapse was 105 days in the 32 patients on risperidone and 57 days in the 31 patients on placebo (P = .069).

Among the 40 patients who were fully nonresponsive to citalopram monotherapy, the median time to relapse was 142 days with risperidone and 35 days with placebo (P = .068).

"These results are consistent with those from the overall population in whom risperidone augmentation offered greater benefit than citalopram monotherapy in the more resistant patient population," Dr. Gharabawi said.

The study was funded by Janssen LP, which manufactures Risperdal.


[Presentation title: Resistant Depression in Older Adults: An International Study of Risperidone Augmentation. Abstract P2.062]

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