Paliperidone ER eases mania, depression.
The drug, which is the principal active metabolite of risperidone (Risperdal) and is currently approved in the United States for the treatment of schizophrenia, also was slightly more effective than its active comparator, quetiapine (Seroquel), although it did provoke more extrapyramidal symptoms, Dr. Eduard Vieta reported in a poster presented at the annual congress of the European College of Neuropsy-cbopharmacology.
The extended-release form of the medication might have a compliancy advantage over other drugs that require multiple daily dosing, reported Dr. Vieta of the University of Barcelona.
The study was conducted at 52 sites in the United States and eight other countries. All 486 patients had a diagnosis of bipolar I disorder. The last episode was manic in 65% and mixed in 35%; 21% had experienced a severe episode with psychosis.
The patients' mean age was 39 years; 39% were rated as at least markedly ill with the Clinical Global Impressions Index.
The study began with a 7-day washout period during which hospitalization was required. Patients were then randomized to 3 weeks of either placebo (104), paliperidone extended release (190), or quetiapine (192),
Patients who were taking paliperidone started at 6 mg/day, which was adjustable by 3-mg increments as needed.
The starting dose of quetiapine was 100 mg/day; everyone was titrated up to 400 mg/day by day 4, and dosing was adjusted in 200-mg increments as needed, Dr. Vieta reported.
The final median daily doses were paliperidone 9 mg, quetiapine 600 mg.
The mean change in the Young Mania Rating Scale (YMRS) score from baseline was -7 in the placebo group, -13 in the paliperidone group, and -12 in the quetiapine group, with paliperidone being significantly more effective than placebo.
The difference in scores between the two active drugs and placebo was significant at day 2.
Clinical response (a decrease in the YMRS of at least 5.0%) occurred in 56% of the paliperidone group, 49% of quetiapine group, and 35% of the placebo group. Paliperidone also significantly improved depression scores, compared with placebo.
On the Montgomery-Asberg Depression Rating Scale, the mean changes from baseline were -2 for placebo, and -4 for both paliperidone and quetiapine.
The Global Assessment of Functioning scale was used as a secondary end point. The mean change in scores from baseline was 7 for placebo, and 12 for both paliperidone and quetiapine.
Overall 76% (371) of the patients completed the study. Completion rates were 62% in the placebo group, 82% in the paliperidone group, and 79% in the quetiapine group.
Most patients reported treatment-emergent adverse events (63% placebo, 65% paliperidone, 77% quetiapine).
Adverse events that were more common in the paliperidone group include somnolence, akathisia, hypertonia, constipation, and dyspepsia.
Extrapyramidal symptoms were more common among patients in the paliperidone group than among those in the placebo group. Symptoms that occurred in at least two more paliperidone patients than placebo patients included hypertonia, drooling, akathisia, muscle spasms, dystonia, dyskinesia, and tremor.
Seventeen percent of those taking paliperidone needed additional drugs to control the extrapyramidal symptoms.
That comapres with 5% of the patients taking placebo and 7% of those taking quetiapine, the investigators found.
The study was sponsored by Johnson & Johnson, which owns Janssen-Cilag, the maker of paliperidone ER.
Dr. Vieta has received research funding from Janssen-Cilag. In addition, Dr. Vieta has been a speaker and consultant for the company.
BY MICHELE G. SULLIVAN
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|Title Annotation:||Adult Psychiatry|
|Author:||Sullivan, Michele G.|
|Publication:||Clinical Psychiatry News|
|Date:||Oct 1, 2008|
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