A randomized, double-blind, placebo-controlled study of 2 dose ranges of paliperidone extended-release in the treatment of subjects with schizoaffective disorder

Journal of Clinical Psychiatry

Volumn 71, Issue 5, 2010, Pages 587-598

  Canuso, Carla M ^a   Lindenmayer, Jean Pierre ^c   Kosik Gonzalez, Colette ^b   Turkoz, Ibrahim ^a   Carothers, Jennifer ^b   Bossie, Cynthia A ^b   Schooler, Nina R ^d  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^b JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^c NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d SUNY DOWNSTATE MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BENZATROPINE; LORAZEPAM; PALIPERIDONE; PLACEBO; PROLACTIN;

ADULT; AGED; AKATHISIA; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANORGASMIA; ARTICLE; BIPOLAR DISORDER; BLOOD ANALYSIS; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; DYSTONIC DISORDER; ELECTROCARDIOGRAPHY MONITORING; ERECTILE DYSFUNCTION; EXCITEMENT; EXTRAPYRAMIDAL SYMPTOM; FEMALE; GALACTORRHEA; GLUCOSE BLOOD LEVEL; HAMILTON ANXIETY SCALE; HOSTILITY; HUMAN; IMPULSE CONTROL DISORDER; INSOMNIA; LABORATORY TEST; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MASTALGIA; MENTAL PATIENT; MUSCLE HYPERTONIA; NAUSEA; POSITIVE AND NEGATIVE SYNDROME SCALE; PRIORITY JOURNAL; PROLACTIN BLOOD LEVEL; PSYCHOSIS; RANDOMIZED CONTROLLED TRIAL; RESTLESSNESS; RHINOPHARYNGITIS; SCHIZOAFFECTIVE PSYCHOSIS; SIDE EFFECT; SOMNOLENCE; STRUCTURED CLINICAL INTERVIEW FOR DSM DISORDERS; SUPRAVENTRICULAR TACHYCARDIA; TARDIVE DYSKINESIA; TENSION; TREATMENT DURATION; TREATMENT OUTCOME; TREMOR; WEIGHT CHANGE; XEROSTOMIA; YOUNG MANIA RATING SCALE;

ADULT; ANTIPSYCHOTIC AGENTS; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; ISOXAZOLES; MALE; PSYCHIATRIC STATUS RATING SCALES; PSYCHOTIC DISORDERS; PYRIMIDINES; TREATMENT OUTCOME;

EID: 77952609966     PISSN: 01606689     EISSN: None     Source Type: Journal    
DOI: 10.4088/JCP.09m05564yel     Document Type: Article

References (29)

1. Cheniaux E, Landeira-Fernandez J, Lessa Telles L, et al. Does schizoaffective disorder really exist? A systematic review of the studies that compared schizoaffective disorder with schizophrenia or mood disorders. J Affect Disord. 2008;106(3):209-217.
2. Potkin SG, Alphs L, Hsu C, et al. InterSePT Study Group. Predicting suicidal risk in schizophrenic and schizoaffective patients in a prospective two-year trial. Biol Psychiatry. 2003;54(4):444-452. doi:10.1016/S06-323(03) 0178-1 PubMed
3. Azorin JM, Kaladjian A, Fakra E. [Current issues on schizoaffective disorder].[Article in French] Encephale. 2005;31(3):359-365.
4. Scully PJ, Owens JM, Kinsella A, et al. Schizophrenia, schizoaffective and bipolar disorder within an epidemiologically complete, homogeneous population in rural Ireland: small area variation in rate. Schizophr Res. 2004;67(2-3):143-155. (Pubitemid 38251444)
5. Kent S, Fogarty M, Yellowlees P. Heavy utilization of inpatient and outpatient services in a public mental health service. Psychiatr Serv. 1995;46(12):1254-1257. d
6. Levinson DF, Umapathy C, Musthaq M. Treatment of schizoaffective disorder and schizophrenia with mood symptoms. Am J Psychiatry. 1999;156(8):1138-1148.
7. Olfson M, Marcus SC, Wan GJ. Treatment patterns for schizoaffective disorder and schizophrenia among Medicaid patients. Psychiatr Serv. 2009;60(2):210-216. i:10.176/api.ps.60.2.210 PubMed
8. Davidson M, Emsley R, Kramer M, et al. Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study. Schizophr Res. 2007;93(1-3):117-130.
9. Kane J, Canas F, Kramer M, et al. Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial. Schizophr Res. 2007;90(1-3):147-161. (Pubitemid 46178537)
10. Kramer M, Simpson G, Maciulis V, et al. Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol. 2007;27(1):6-14. (Pubitemid 46105757)
11. Marder SR, Kramer M, Ford L, et al. Efficacy and safety of paliperidone extended-release tablets: results of a 6-week, randomized, placebo-controlled study. Biol Psychiatry. 2007;62(12):1363-1370. doi:10.1016/j.biopsych.207.01.017 PubMed 12. Vieta E, Berwaerts J, Nuamah I, et al. Randomized, placebo- and active- controlled study of paliperidone ER for acute manic and mixed episodes in bipolar I disorder. Poster presented at ECNP; August 30-September 3, 2008; Barcelona, Spain. (Pubitemid 350180724)
12. Canuso CM, Bossie CA, Turkoz I, et al. Efficacy and safety of paliperidone extended-release in schizophrenia patients with prominent affective symptoms. J Affect Disord. 2010; 120(1-3)193-199.
13. Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-276. PubMed
14. Evaluation of Effectiveness and Safety of Flexible-Dose Paliperidone Extended Release in Patients With Schizoaffective Disorder. Clinicaltrial.gov identifier: NCT00412373. Clinicaltrials.gov. http://clinicaltrials.gov/ct2/show/ NCT00412373?term= NCT00412373&rank=1. Accessed March 1, 2010.
15. First MB, Spitzer RL, Gibbon M, et al. Structured Clinical Interview for DSM-IV Axis I Disorders. New York, NY: State Psychiatric Institute, Biometrics Research; 1995.
16. Young RC, Biggs JT, Ziegler VE, et al. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978;133(5):429-435. (Pubitemid 9006756)
17. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23(1):56-62.
18. Allen M, Bartko JJ, Lindenmayer JP. Development and Psychometric Exploration of a Clinical Global Impressions Scale for Schizoaffective Disorder (CGI-SCA). Poster presented at the 49th Annual New Clinical Drug Evaluation Unit Meeting; June 29-July 2, 2009; Hollywood, FL.
19. Simpson GM, Angus JW. A rating scale for extrapyramidal side effects. Acta Psychiatr Scand suppl. 1970;45(S212):11-19.
20. Psychopharmacology Research Branch, National Institute of Mental Health. Abnormal Involuntary Movement Scale (AIMS). In: Guy W, ed. ECDEU Assessment Manual for Psychopharmacology, Revised. US Dept Health, Education, and Welfare publication (ADM) 76-338. Rockville, Md: National Institute of Mental Health; 1976:534-537.
21. Barnes TR. A rating scale for drug-induced akathisia. Br J Psychiatry. 1989;154(5):672-676.
22. Lindenmayer JP, Czobor P, Alphs L, et al. InterSePT Study Group. The InterSePT Scale for Suicidal Thinking reliability and validity. Schizophr Res. 2003;63(1-2):161-170.
23. Leucht S, Kane JM, Etschel E, et al. Linking the PANSS, BPRS, and CGI: clinical implications. Neuropsychopharmacology. 2006;31(10): 2318-2325. (Pubitemid 44413213)
24. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.
25. Spina E, Cavallaro R. The pharmacology and safety of paliperidone extended-release in the treatment of schizophrenia. Expert Opin Drug Saf. 2007;6(6):651-662. (Pubitemid 351308277)
26. Kemp AS, Schooler NR, Kalali AH, et al. What is causing the reduced drug-placebo difference in recent schizophrenia clinical trials and what can be done about it? Schizophr Bull. 2008;(Aug):22 [Epub ahead of print].
27. Tran PV, Tollefson GD, Sanger TM, et al. Olanzapine versus haloperidol in the treatment of schizoaffective disorder: acute and long-term therapy. Br J Psychiatry. 1999;174(1):15-22.
28. Vieta E, Herraiz M, Fernández A, et al. Group for the Study of Risperidone in Affective Disorders (GSRAD). Efficacy and safety of risperidone in the treatment of schizoaffective disorder: initial results from a large, multicenter surveillance study. J Clin Psychiatry. 2001;62(8): 623-630.
29. Janicak PG, Keck PE Jr, Davis JM, et al. A double-blind, randomized, prospective evaluation of the efficacy and safety of risperidone versus haloperidol in the treatment of schizoaffective disorder. J Clin Psychopharmacol. 2001;21(4):360-368.