Efficacy and Safety of Paliperidone Extended-Release Tablets: Results of a 6-Week, Randomized, Placebo-Controlled Study

Biological Psychiatry

Volumn 62, Issue 12, 2007, Pages 1363-1370

  Marder, Stephen R ^a,b   Kramer, Michelle ^c   Ford, Lisa ^c   Eerdekens, Els ^d   Lim, Pilar ^c   Eerdekens, Mariëlle ^d   Lowy, Adam ^e  

^a Education   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

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

^d JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^e Univ S Carolina Sch Med Vice P   (United States)

Author keywords

Atypical antipsychotic; efficacy; paliperidone ER; schizophrenia; tolerability

Indexed keywords

GLUCOSE; LIPID; OLANZAPINE; PALIPERIDONE; PLACEBO;

ADULT; AGITATION; ANXIETY DISORDER; ARTICLE; BODY WEIGHT; CARDIOVASCULAR SYMPTOM; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; EXTRAPYRAMIDAL SYNDROME; FEMALE; GLUCOSE BLOOD LEVEL; HEADACHE; HUMAN; HYPERKINESIA; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; NAUSEA; PAIN; POSITIVE AND NEGATIVE SYNDROME SCALE; PRIORITY JOURNAL; PROLACTIN BLOOD LEVEL; PSYCHOSIS; RANDOMIZED CONTROLLED TRIAL; RASH; SCHIZOPHRENIA; SIDE EFFECT; SOMNOLENCE; TACHYCARDIA; TOOTH PAIN; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; VOMITING; XEROSTOMIA;

ADULT; ANALYSIS OF VARIANCE; ANTIPSYCHOTIC AGENTS; BLOOD GLUCOSE; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG EVALUATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; ISOXAZOLES; LIPID METABOLISM; MALE; MIDDLE AGED; PSYCHIATRIC STATUS RATING SCALES; PYRIMIDINES; SCHIZOPHRENIA; TREATMENT OUTCOME;

EID: 36048941530     PISSN: 00063223     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.biopsych.2007.01.017     Document Type: Article

References (34)

1. Keith S.J., and Kane J.M. Partial compliance and patient consequences in schizophrenia: Our patients can do better. J Clin Psychiatry 64 (2003) 1308-1315
2. Lieberman J.A., Stroup T.S., McEvoy J.P., Swartz M.S., Rosenheck R.A., Perkins D.O., et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 353 (2005) 1209-1223
3. Masand P.S., and Berry S.L. Switching antipsychotic therapies. Ann Pharmacother 34 (2000) 200-207
4. Nasrallah H.A., Targum S.D., Tandon R., McCombs J.S., and Ross R. Defining and measuring clinical effectiveness in the treatment of schizophrenia. Psychiatr Serv 56 (2005) 273-282
5. Karow A., and Naber D. Subjective well-being and quality of life under atypical antipsychotic treatment. Psychopharmacology (Berl) 162 (2002) 3-10
6. Saleem P., Olie J.P., and Loo H. Social functioning and quality of life in the schizophrenic patient: Advantages of amisulpride. Int Clin Psychopharmacol 17 (2002) 1-8
7. Morosini P.L. Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand 101 (2000) 323-329
8. Gagnon D., Adriaenssen I., Nasrallah H., and Morosini P. Reliability, validity and sensitivity to change of the personal and social performance scale in patients with stable schizophrenia. Int J Neuropsychopharmacol 9 suppl 1 (2006) 288
9. Patrick D., Adriaenssen I., Morosini P., and Rothman M. Reliability, validity and sensitivity to change of the personal and social performance scale in patients with acute schizophrenia. Int J Neuropsychopharmacol 9 (2006) S287-S288
10. Ceskova E., and Svestka J. Double-blind comparison of risperidone and haloperidol in schizophrenic and schizoaffective psychoses. Pharmacopsychiatry 26 (1993) 121-124
11. Lindstrom E., Eriksson B., Hellgren A., von Knorring L., and Eberhard G. Efficacy and safety of risperidone in the long-term treatment of patients with schizophrenia. Clin Ther 17 (1997) 402-412
12. Moller H., Gagiano C., Addington D., Von Knorring L., Torres-Plank J., and Gaussares C. Long-term treatment of chronic schizophrenia with risperidone: An open-label, multicenter study of 386 patients. Int Clin Psychopharmacol 13 (1998) 99-106
13. Peuskens J., and Group R.S. Risperidone in the treatment of patients with chronic schizophrenia: A multi-national, multi-centre, double-blind, parallel-group study versus haloperidol. Br J Psychiatry 166 (1995) 712-716
14. Conley R., Gupta S., and Sathyan G. Clinical spectrum of the osmotic-controlled release oral delivery system (OROS), an advanced oral delivery form. Curr Med Res Opin 22 (2006) 1879-1892
15. Karlsson P., Dencker E., Nyberg S., Cselenyi Z., Mannaert E., Boom S., et al. Pharmacokinetics, dopamine D2 and serotonin 5-HT2A receptor occupancy and safety profile of paliperidone extended-release in healthy subjects. Clin Pharmacol Ther 79 (2006) P111-P157
16. Vermeir M., Boom S., Naessens I., Talluri K., and Eerdekens M. Absorption, metabolism and excretion of a single oral dose of 14C-paliperidone 1 mg in healthy subjects. Eur Neuropsychopharmacol 30 (2005) S191-S192
17. Kay S., Opler L., and Fizbein A. The positive and negative syndrome scale (PANSS) manual (1986), Multi-Health System, North Tohawanda, NY
18. Marder S.R., Davis J.M., and Chouinard G. The effects of risperidone on the five dimensions of schizophrenia derived by factor analysis: Combined results of the North American trials. J Clin Psychiatry 58 (1997) 538-546
19. Guy W. Clinical Global Impressions Scale. ECDEU Assessment manual (1976) 218-222
20. Malik M., and Camm A. Evaluation of drug-induced QT interval prolongation: Implications for drug approval and labelling. Drug Saf 24 (2001) 323-351
21. Hodges M. Rate correction of the QT interval. Cardiac Electrophysiol Rev 1 (1997) 360-363
22. Welge J., and Keck P. Moderators of placebo response to antipsychotic treatment in patients with schizophrenia: A meta-regression. Psychopharmacology 166 (2003) 1-10
23. Kane J., Canas F., Kramer M., Ford L., Gassman-Mayer C., Lim P., et al. Treatment of schizophrenia with paliperidone extended-release tablets: A 6-week placebo-controlled trial. Schizophr Res 90 (2007) 147-161
24. Wahlbeck K., Tuunainen A., Ahokas A., and Leucht S. Dropout rates in randomised antipsychotic drug trials. Psychopharmacology (Berl) 155 (2001) 230-233
25. Storosum J., Elferink A., and van Zwieten B. Schizophrenia: Do we really need placebo-controlled studies?. Eur Neuropsychopharmacol 8 (1998) 279-286
26. Citrome L.L. The increase in risk of diabetes mellitus from exposure to second-generation antipsychotic agents. Drugs Today (Barc) 40 (2004) 445-464
27. American Psychiatric Association and American Diabetic Association. Consensus development conference on antipsychotic drugs and obesity and diabetes. J Clin Psychiatry 65 (2004) 267-272
28. Sernyak M.J., Leslie D.L., Alarcon R.D., Losonczy M.F., and Rosenheck R. Association of diabetes mellitus with use of atypical neuroleptics in the treatment of schizophrenia. Am J Psychiatry 159 (2002) 561-566
29. Karlsson P., Dencker D., Nyberg S., Mannaert E., Boom S., Talluri K., et al. Pharmacokinetics and dopamine d2 and serotonin 5-HT2A receptor occupancy of paliperidone in healthy subjects. Eur Neuropsychopharmacol 15 suppl 3 (2005) 385
30. Bhana N., Foster R., Olney R., and Plosker G. Olanzapine: An updated review of its use in the management of schizophrenia. Drugs 61 (2001) 111-161
31. Ereshefsky L., and Mascarenas C.A. Comparison of the effects of different routes of antipsychotic administration on pharmacokinetics and pharmacodynamics. J Clin Psychiatry 64 suppl 16 (2003) 18-23
32. Kapur S., Zipursky R., Jones C., Remington G., and Houle S. Relationship between dopamine D(2) occupancy, clinical response, and side effects: A double-blind PET study of first-episode schizophrenia. Am J Psychiatry 157 (2000) 514-520
33. Kramer M., Kushner S., Vijapurkar U., Lim P., and Eerdekens M. Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: A randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol 27 (2007) 6-14
34. Davidson M., Emsley R., Kramer M., Ford L., Gassmann-Mayer C., Lim P., et al. Efficacy and safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study. Schizophr Res (2007) Apr 26; Epub ahead of print; doi:10.1016/j.schres.2007.03.003