paliperidone-palmitate and Mood-Disorders

This post-hoc analysis evaluated the effects of paliperidone extended-release (ER) in patients with schizophrenia and prominent affective symptoms.. Pooled data from three 6-week, randomized, double-blind, placebo-controlled studies were analyzed. Subjects received fixed doses of paliperidone ER 3-12 mg/day or placebo. Prominent affective symptoms were defined as depressive (Positive and Negative Syndrome Scale [PANSS] depression item score of > or =5 [moderately severe]) and/or manic (PANSS grandiosity score of > or =4 [moderate], plus a score of > or =4 [moderate] on at least 1 PANSS item for excitement, hostility, uncooperativeness, or poor impulse control). Assessments included PANSS, Clinical Global Impressions-Severity (CGI-S), Personal and Social Performance (PSP) scale, and adverse events (AEs).. Among 193 patients with prominent affective symptoms, 140 received paliperidone ER and 53 received placebo. Paliperidone ER showed significant mean (SD) improvements vs. placebo in PANSS total (-20.5 [23.8] vs. -6.3 [27.2]; p<0.001, respectively) and all factor scores (p<0.01). Significant mean (SD) improvements were observed in PSP (7.2 [15.8] vs. 0.4 [14.6]; p=0.004) and CGI-S (-0.9 [1.2] vs. -0.3 [1.2]; p<0.001) scores. Most common AEs with paliperidone ER vs. placebo: headache (16.4% vs. 13.2%), insomnia (7.9% vs. 9.4%), akathisia (7.1% vs. 1.9%), sedation (7.1% vs. 3.8%).. These studies were not designed to examine patients with prominent affective symptoms. Authors' clinical judgment was used to define prominent affective symptoms, using relevant PANSS items.. Paliperidone ER was well tolerated and associated with significantly greater improvements in symptomatology, functioning, and overall clinical status vs. placebo in patients with schizophrenia and prominent affective symptoms.

Topics: Adult; Antipsychotic Agents; Delayed-Action Preparations; Double-Blind Method; Female; Humans; Isoxazoles; Male; Mood Disorders; Paliperidone Palmitate; Pyrimidines; Schizophrenia; Severity of Illness Index

Paliperidone prolonged release (PR) is a new product licensed for the treatment of schizophrenia. It is the active metabolite of risperidone, a drug that has been successfully used in the treatment of schizophrenia and mood disorder. Paliperidone PR has a unique pharmacological delivery mechanism that may incur benefits for particular patients diagnosed with schizophrenia. Studies investigating paliperidone PR are reviewed along with implications for its use by nurse prescribers and those nurses who monitor the use of medication for people with psychosis.

Topics: Antipsychotic Agents; Capsules; Decision Making; Delayed-Action Preparations; Humans; Isoxazoles; Mood Disorders; Paliperidone Palmitate; Pyrimidines; Receptors, Dopamine; Schizophrenia