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Randomized Controlled Trial
. 2017 Apr;205(4):324-328.
doi: 10.1097/NMD.0000000000000646.

Paliperidone Palmitate Once-Monthly Treatment in Recent Onset and Chronic Illness Patients With Schizoaffective Disorder

Affiliations
Randomized Controlled Trial

Paliperidone Palmitate Once-Monthly Treatment in Recent Onset and Chronic Illness Patients With Schizoaffective Disorder

Cynthia A Bossie et al. J Nerv Ment Dis. 2017 Apr.

Abstract

Data from a multiphase schizoaffective disorder study (NCT01193153) were used to examine the effects of paliperidone palmitate once-monthly (PP1M) by subjects' illness duration, defined as recent onset (≤5 years since first psychiatric diagnosis; n = 206) and chronic illness (>5 years; n = 461). Symptom and functioning scores, as measured during open-label PP1M acute and stabilization treatment phases, improved in both subpopulations, with greater improvements in recent onset than chronic illness subjects (p ≤ 0.022). Relapse rates, examined during the double-blind, placebo-controlled phase, were higher with placebo than PP1M: 30.0% vs. 10.2% (p = 0.014; hazard ratio [HR]: 2.8; 95% confidence interval [CI]: 1.11-7.12; p = 0.029) in the recent onset subpopulation and 35.5% vs. 18.1% (p = 0.001; HR: 2.38; 95% CI: 1.37-4.12; p = 0.002) in the chronic illness subpopulation. Growing evidence in the treatment of schizophrenia and schizoaffective disorder supports early intervention with long-acting antipsychotics.

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Figures

FIGURE 1
FIGURE 1
Changes in PANSS, HAM-D-21, YMRS, PSP, and percentage of subjects meeting stabilization criteria with PP1M treatment in the OL acute and stabilization phases. Subjects in both subpopulations exhibited significant improvements from baseline in PANSS total score, HAM-D-21 total score, YMRS total score, and PSP (paired t-test). In comparisons between the recent onset and chronic illness patients, significantly greater improvements were observed among the recent onset (t-test). A significantly higher percentage of subjects with recent onset illness entered the DB phase (chi-square test). Implications of instrument score changes: PANSS, HAM-D-21, and YMRS—negative changes indicate improvement; PSP—positive change indicates improvement.

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