Efficacy and safety of paliperidone extended-release in schizophrenia patients with prominent affective symptoms.
BACKGROUND
This post-hoc analysis evaluated the effects of paliperidone extended-release (ER) in patients with schizophrenia and prominent affective symptoms.


METHODS
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).


RESULTS
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%).


CONCLUSIONS
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.


CONCLUSIONS
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.
Canuso
Carla M
CM
Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ 08560-0200, USA. CCanuso@its.jnj.com
Turkoz
Ibrahim
I
Sheehan
John J
JJ
Bossie
Cynthia A
CA
D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D019964:Mood Disorders / Q000175:diagnosis / Q000453:epidemiology* / Q000523:psychology; D000068882:Paliperidone Palmitate; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy* / Q000453:epidemiology*; D012720:Severity of Illness Index
D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D007555:Isoxazoles; D011743:Pyrimidines; D000068882:Paliperidone Palmitate