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| |  Risperidone in the Treatment of Mania BELMONT, Mass., June 27,1996 -- Risperidone (RISPERDAL(R)) may provide effective treatment of patients experiencing an acute episode of bipolar disorder, manic type, with psychotic features, according to the results of a pilot study reported this month in The Journal of Clinical Psychiatry. Researchers at McLean Hospital and Harvard Medical School, led by Mauricio Tohen, M.D., Dr. P.H., set out to investigate whether risperidone, a novel antipsychotic agent with efficacy shown superior to haloperidol in the treatment of positive and negative symptoms of schizophrenia, would also be effective in the treatment of affective disorders with a psychotic component. They conducted an open-label pilot study in 15 patients at McLean Hospital who had acute mania with psychotic features. Inclusion criteria included minimum scores of 45 on the 24-item modified Brief Psychiatric Rating Scale (BPRS) and 20 on the Young Mania Rating Scale (YMRS). Patients were allowed to continue taking previously prescribed mood-stabilizing drugs, and risperidone was administered orally in the morning and evening for 6 weeks. Of the 13 patients who completed two weeks of treatment, eight had a 50 percent improvement in BPRS scores, and all 13 had at least a 25 percent improvement. Of the eight patients who completed six weeks of treatment, seven had a 50 percent improvement, and all eight had at least a 25 percent improvement. Similar results were obtained with the YMRS. By Week two, 10 of the 13 patients remaining in treatment had a 50 percent improvement in YMRS scores, and 12 of these 13 had at least a 25 percent improvement. By Week six, all eight patients remaining in treatment had a 75 percent improvement. Bipolar disorder is a major public health problem, affecting up to 2.5 percent of the population. Before treatments became available, bipolar patients spent one fourth of their adult life hospitalized and one fourth in a disabled condition, at a cost of more than $5 million per patient. At present, the treatments available for patients with bipolar disorder are limited in number. Lithium and valproate are the most widely used mood-stabilizers. How to treat those patients who do not tolerate or do not respond to the current antimanic agents is a pressing treatment dilemma. All of the patients in Tohen and colleagues' study had been receiving mood-stabilizers before hospitalization and study initiation, suggesting that these patients as a whole were nonresponsive or poorly responsive to traditional therapy. Prestudy rating scale scores also indicated that their bipolar population was severely symptomatic. Their preliminary positive findings add to the growing scientific literature supporting the use of atypical antipsychotics for the treatment of affective disorders. In addition to the improvement noted in all patients, the researchers emphasized that the medication was well-tolerated and that the results "clearly show that no patient worsened." If the encouraging results of Tohen and colleagues are replicated in controlled studies, risperidone may become a treatment option for this patient population. Given the methodological limitations of their study, including open design, small sample size, and limited period of observation, the researchers urge that the results be interpreted with caution. They highlighted several variables that may relate to study outcome. In particular, they noted that all patients in the current study received concurrent treatment with mood-stabilizing drugs. Additionally, all of their patients were treated with relatively low doses of risperidone (ranging from 2 mg/day to a maximum dose of 6 mg/day). Risperidone, introduced in the United States in 1994, belongs to a new chemical class -- the benzisoxazol derivatives. It has a unique pharmacological profile displayed by its potent serotonin (5-HT2) and dopamine (D2) receptor antagonism. This profile may explain its antipsychotic and mood-stabilizing effects, along with its low incidence of extrapyramidal symptoms. Because up to 60% of patients with acute mania are now treated with antipsychotic drugs, the lower potential of risperidone to cause adverse effects when compared with conventional antipsychotic agents is an important consideration for patient compliance with the medication regimen. Traditionally, clinicians have attempted to limit antipsychotic drug exposure in mood disordered patients because this population has been reported to be at increased risk for extrapyramidal symptoms. Dr. Tohen is an associate professor of psychiatry at Harvard Medical School, chief of the Psychiatric Epidemiology Laboratory at the Harvard School of Public Health in Boston, and clinical director of the Bipolar and Psychotic Disorders Program at McLean Hospital in Belmont, Massachusetts. McLean Hospital is a nonprofit center for psychiatric and chemical dependency treatment, teaching, and research, located 10 miles west of Boston. Consistently ranked as one of the nation's best hospitals for mental health care, McLean maintains the largest research program of any private psychiatric hospital. McLean is a teaching facility of Harvard Medical School, an affiliate of Massachusetts General Hospital and a member of the Partners HealthCare System. The Journal of Clinical Psychiatry is a monthly peer-reviewed journal that publishes articles of relevance to practicing clinical psychiatrists. This publication is one of the most widely read psychiatric journals and is indexed by all major data bases, including Index Medicus.
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