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A randomized, double-blind, placebo-controlled study of 2 dose ranges of paliperidone extended-release in the treatment of subjects with schizoaffective disorder.
J Clin Psychiatry. 2010 May; 71(5):587-98.JC

Abstract

OBJECTIVE

This study was designed to assess efficacy and safety of paliperidone extended-release (ER) in patients with schizoaffective disorder.

METHOD

A randomized, 6-week, double-blind, placebo-controlled study was conducted. Subjects with a Structured Clinical Interview for DSM-IV diagnosis of schizoaffective disorder, Positive and Negative Syndrome Scale (PANSS) total score >or= 60, score >or= 4 on >or= 2 PANSS items (hostility, excitement, tension, uncooperativeness, poor impulse control), and Young Mania Rating Scale and/or Hamilton Depression Rating Scale, 21-item version scores >or= 16 were eligible. Subjects received higher-dose (12 mg/d) or lower-dose (6 mg/d) paliperidone ER. Dose adjustments by 3-mg increments were allowed until day 15. The study was conducted from October 2006 through February 2008.

RESULTS

A total of 316 subjects were randomly assigned to paliperidone ER lower dose (n = 109), higher dose (n = 100), or placebo (n = 107). Mean +/- SD modal dose in lower- and higher-dose groups: 5.7 +/- 0.9 and 11.6 +/- 1.0 mg/d, respectively. Mean +/- SE PANSS total score (primary outcome) improved significantly with higher-dose paliperidone ER versus placebo (-32.4 +/- 2.1 versus -24.1 +/- 2.1; P = .003). Change with lower-dose paliperidone ER (-27.7 +/- 2.1) was not significantly different from placebo (P = .187). No new safety issues were identified; common adverse events were headache (placebo: 16.8%; paliperidone ER: lower dose, 13.9%, higher dose, 13.3%) and tremor (3.7%, 12.0%, 11.2%, respectively). Mean prolactin and weight changes were greater with active treatment than placebo.

CONCLUSIONS

Higher-dose paliperidone ER was effective and well tolerated in patients with acute schizoaffective disorder. These findings and those from a companion study constitute the first registration program for antipsychotic treatment in schizoaffective disorder.

TRIAL REGISTRATION

clincaltrials.gov Identifier: NCT00397033.

Authors+Show Affiliations

Johnson & Johnson Pharmaceutical Research and Development, LLC, 1125 Trenton-Harbourton Rd-E12604, Titusville, NJ 08560, USA. ccanuso@its.jnj.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20492853

Citation

Canuso, Carla M., et al. "A Randomized, Double-blind, Placebo-controlled Study of 2 Dose Ranges of Paliperidone Extended-release in the Treatment of Subjects With Schizoaffective Disorder." The Journal of Clinical Psychiatry, vol. 71, no. 5, 2010, pp. 587-98.
Canuso CM, Lindenmayer JP, Kosik-Gonzalez C, et al. A randomized, double-blind, placebo-controlled study of 2 dose ranges of paliperidone extended-release in the treatment of subjects with schizoaffective disorder. J Clin Psychiatry. 2010;71(5):587-98.
Canuso, C. M., Lindenmayer, J. P., Kosik-Gonzalez, C., Turkoz, I., Carothers, J., Bossie, C. A., & Schooler, N. R. (2010). A randomized, double-blind, placebo-controlled study of 2 dose ranges of paliperidone extended-release in the treatment of subjects with schizoaffective disorder. The Journal of Clinical Psychiatry, 71(5), 587-98. https://doi.org/10.4088/JCP.09m05564yel
Canuso CM, et al. A Randomized, Double-blind, Placebo-controlled Study of 2 Dose Ranges of Paliperidone Extended-release in the Treatment of Subjects With Schizoaffective Disorder. J Clin Psychiatry. 2010;71(5):587-98. PubMed PMID: 20492853.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, placebo-controlled study of 2 dose ranges of paliperidone extended-release in the treatment of subjects with schizoaffective disorder. AU - Canuso,Carla M, AU - Lindenmayer,Jean-Pierre, AU - Kosik-Gonzalez,Colette, AU - Turkoz,Ibrahim, AU - Carothers,Jennifer, AU - Bossie,Cynthia A, AU - Schooler,Nina R, PY - 2009/07/28/received PY - 2010/02/11/accepted PY - 2010/5/25/entrez PY - 2010/5/25/pubmed PY - 2010/6/12/medline SP - 587 EP - 98 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 71 IS - 5 N2 - OBJECTIVE: This study was designed to assess efficacy and safety of paliperidone extended-release (ER) in patients with schizoaffective disorder. METHOD: A randomized, 6-week, double-blind, placebo-controlled study was conducted. Subjects with a Structured Clinical Interview for DSM-IV diagnosis of schizoaffective disorder, Positive and Negative Syndrome Scale (PANSS) total score >or= 60, score >or= 4 on >or= 2 PANSS items (hostility, excitement, tension, uncooperativeness, poor impulse control), and Young Mania Rating Scale and/or Hamilton Depression Rating Scale, 21-item version scores >or= 16 were eligible. Subjects received higher-dose (12 mg/d) or lower-dose (6 mg/d) paliperidone ER. Dose adjustments by 3-mg increments were allowed until day 15. The study was conducted from October 2006 through February 2008. RESULTS: A total of 316 subjects were randomly assigned to paliperidone ER lower dose (n = 109), higher dose (n = 100), or placebo (n = 107). Mean +/- SD modal dose in lower- and higher-dose groups: 5.7 +/- 0.9 and 11.6 +/- 1.0 mg/d, respectively. Mean +/- SE PANSS total score (primary outcome) improved significantly with higher-dose paliperidone ER versus placebo (-32.4 +/- 2.1 versus -24.1 +/- 2.1; P = .003). Change with lower-dose paliperidone ER (-27.7 +/- 2.1) was not significantly different from placebo (P = .187). No new safety issues were identified; common adverse events were headache (placebo: 16.8%; paliperidone ER: lower dose, 13.9%, higher dose, 13.3%) and tremor (3.7%, 12.0%, 11.2%, respectively). Mean prolactin and weight changes were greater with active treatment than placebo. CONCLUSIONS: Higher-dose paliperidone ER was effective and well tolerated in patients with acute schizoaffective disorder. These findings and those from a companion study constitute the first registration program for antipsychotic treatment in schizoaffective disorder. TRIAL REGISTRATION: clincaltrials.gov Identifier: NCT00397033. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/20492853/A_randomized_double_blind_placebo_controlled_study_of_2_dose_ranges_of_paliperidone_extended_release_in_the_treatment_of_subjects_with_schizoaffective_disorder_ L2 - http://www.psychiatrist.com/jcp/article/pages/2010/v71n05/v71n0510.aspx DB - PRIME DP - Unbound Medicine ER -