Hostname: page-component-586b7cd67f-gb8f7 Total loading time: 0 Render date: 2024-11-28T17:09:27.220Z Has data issue: false hasContentIssue false
  • English
  • Français

A Pilot, 15-month, randomised effectiveness trial of Risperidone long-acting injection (RLAI) versus oral atypical antipsychotic agents (AAP) in persons with bipolar disorder

Published online by Cambridge University Press:  24 June 2014

K. N. Roy Chengappa ,
Scott R. Turkin ,
Patricia J. Schlicht ,
Sherry L. Murphy ,
Jaspreet S. Brar ,
Andrea Fagiolini ,
Patricia R. Houck ,
Ronald G. Garbutt  and
Noreen Fredrick
K. N. Roy Chengappa*
Affiliation:
Western Psychiatric Institute and Clinic, University of Pittsburgh, Pittsburgh, PA, USA Mayview State Hospital, Bridgeville, PA, USA
Scott R. Turkin
Affiliation:
Dubois Regional Medical Center, Dubois, PA, USA
Patricia J. Schlicht
Affiliation:
Western Psychiatric Institute and Clinic, University of Pittsburgh, Pittsburgh, PA, USA
Sherry L. Murphy
Affiliation:
Dubois Regional Medical Center, Dubois, PA, USA
Jaspreet S. Brar
Affiliation:
Western Psychiatric Institute and Clinic, University of Pittsburgh, Pittsburgh, PA, USA
Andrea Fagiolini
Affiliation:
Western Psychiatric Institute and Clinic, University of Pittsburgh, Pittsburgh, PA, USA University of Siena, Dept of Neuroscience, Siena, Italy
Patricia R. Houck
Affiliation:
Western Psychiatric Institute and Clinic, University of Pittsburgh, Pittsburgh, PA, USA
Ronald G. Garbutt
Affiliation:
Western Psychiatric Institute and Clinic, University of Pittsburgh, Pittsburgh, PA, USA
Noreen Fredrick
Affiliation:
Mon Yough Community Services, Inc., McKeesport, PA, USA
*
Prof. K. N. Roy Chengappa, MD, Chief, Services for Research and Recovery in Serious Mental Illness, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, 3811 O’Hara Street, Pittsburgh, PA 15213-2593, USA. Tel: 412 246 5006; Fax: 412 246 5007; E-mail: [email protected]
Get access Rights & Permissions [Opens in a new window]

Abstract

Chengappa KNR, Turkin SR, Schlicht PJ, Murphy SL, Brar JS, Fagiolini A, Houck PR, Garbutt RG, Fredrick N. A Pilot, 15-month, randomised effectiveness trial of Risperidone long acting injection (RLAI) versus oral atypical antipsychotic agents (AAP) in persons with bipolar disorder.

Objective:

Long-acting injectible antipsychotic agents are rarely considered in the treatment of bipolar patients [bipolar disorder (BPD)]. We posited that BPD patients receiving risperidone long-acting injections [Risperidone long-acting injections (RLAIs)] would experience fewer negative clinical events than those receiving oral atypical antipsychotic agents (AAP).

Methods:

Adult BPD patients in a hypomanic, manic or mixed episode were randomised to either oral risperdone followed by RLAI (n = 23) or an AAP (n = 25) for 15 months. Any mood stabilizers were continued. An independent clinician board declared any clinical events that occurred but the treatment assignment was concealed.

Results:

Nine of the 48 patients who participated in this study did not improve, leaving 39 patients in 1-year extension. RLAI patients received the following bi-weekly dosages: 25 mg (n = 9), 37.5 mg (n = 8), and 50 mg (n = 6). The AAP group included aripiprazole (n = 11, 15–30 mg/day), quetiapine (n = 8, 300–700 mg/day), olanzapine (n = 5, 15–25 mg/day), and ziprasidone, (n = 1, 160 mg/day). In total, 47 clinical events were declared. The RLAI-treated group experienced significantly fewer clinical events (mean: 0.86 ± 0.73) compared with the AAP group (1.61 ± 1.29), t = 2.29, d.f. = 37, p = 0.028 (95% CI = 0.087–1.421). Of all, 50% of the AAP subjects gained ≥ 7% of their baseline body weight as did 38% of the RLAI-treated patients.

Conclusions:

RLAI-treated patients experienced significantly fewer negative clinical events. Further exploration should focus on which subtypes of BPD patients might benefit from RLAI treatment. Weight gain in BPD subjects requires clinical attention. Limitations include an open design, small sample size and the inability to conclude on whether this strategy is useful for depressive episodes.

Keywords

bipolar disorderclinical triallong-acting risperidone injectionrandomised
Type
Research Article
Information
Acta Neuropsychiatrica , Volume 22 , Issue 2 , April 2010 , pp. 68 - 80
Copyright
Copyright © 2010 John Wiley & Sons A/S

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Woltmann, EM, Valenstein, M, Welsh, DEet al. Using pharmacy data on partial adherence to inform clinical care of patients with serious mental illness. Psychiatr Serv 2007;58:864–867. CrossRefGoogle ScholarPubMed
Svarstad, BL, Shireman, TI, Sweeney, JK.Using drug claims data to assess the relationship of medication adherence with hospitalization and costs. Psychiatr Serv 2001;52:805–811. CrossRefGoogle ScholarPubMed
Scott, J, Pope, M.Self-reported adherence to treatment with mood stabilizers, plasma levels, and psychiatric hospitalization. Am J Psychiatry 2002;159:1927–1929. CrossRefGoogle ScholarPubMed
Davis, JM, Kane, JM, Marder, SRet al. Dose response of prophylactic antipsychotics. J Clin Psychiatry 1993; 54(Suppl.):24–30. Google ScholarPubMed
Schooler, NR.Relapse and rehospitalization: comparing oral and depot antipsychotics. J Clin Psychiatry 2003;64(Suppl. 16):14–17. Google ScholarPubMed
Ahlfors, UG, Baastrup, PC, Dencker, SJet al. Flupenthixol decanoate in recurrent manic-depressive illness. A comparison with lithium. Acta Psychiatr Scand 1981;64:226–237. CrossRefGoogle ScholarPubMed
White, E, Cheung, P, Silverstone, T.Depot antipsychotics in bipolar affective disorder. Int Clin Psychopharmacol 1993;8:119–122. CrossRefGoogle ScholarPubMed
Littlejohn, R, Leslie, F, Cookson, J.Depot antipsychotics in the prophylaxis of bipolar affective disorder. Br J Psychiatry 1994;165:827–829. CrossRefGoogle ScholarPubMed
Tohen, M, Sanger, TM, McElroy, SLet al. Olanzapine versus placebo in the treatment of acute mania. Olanzapine HGEH Study Group. Am J Psychiatry 1999;156:702–709. CrossRefGoogle ScholarPubMed
Khanna, S, Vieta, E, Lyons, Bet al. Risperidone in the treatment of acute mania: double-blind, placebo-controlled study. Br J Psychiatry 2005;187:229–234. CrossRefGoogle ScholarPubMed
Bowden, CL, Grunze, H, Mullen, Jet al. A randomized, double-blind, placebo-controlled efficacy and safety study of quetiapine or lithium as monotherapy for mania in bipolar disorder. J Clin Psychiatry 2005;66:111–121. CrossRefGoogle ScholarPubMed
Keck, PE Jr, Marcus, R, Tourkodimitris, Set al. A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania. Am J Psychiatry 2003;160:1651–1658. CrossRefGoogle ScholarPubMed
Keck, PE Jr, Versiani, M, Potkin, Set al. Ziprasidone in the treatment of acute bipolar mania: a three-week, placebo-controlled, double-blind, randomized trial. Am J Psychiatry 2003;160:741–748. CrossRefGoogle Scholar
Tohen, M, Vieta, E, Calabrese, Jet al. Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression. [erratum appears in Arch Gen Psychiatry. 2004 Feb;61(2):176]. Arch Gen Psychiatry 2003;60:1079–1088. CrossRefGoogle ScholarPubMed
Calabrese, JR, Keck, PE Jr, Macfadden, Wet al. A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry 2005;162:1351–1360. CrossRefGoogle ScholarPubMed
Kane, JM, Eerdekens, M, Lindenmayer, JPet al. Long-acting injectable risperidone: efficacy and safety of the first long-acting atypical antipsychotic. Am J Psychiatry 2003;160:1125–1132. CrossRefGoogle ScholarPubMed
Fleischhacker, WW, Eerdekens, M, Karcher, Ket al. Treatment of schizophrenia with long-acting injectable risperidone: a 12-month open-label trial of the first long-acting second-generation antipsychotic. J Clin Psychiatry 2003;64:1250–1257. CrossRefGoogle ScholarPubMed
Young, RC, Biggs, JT, Ziegler, VE, Meyer, DA.A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 1978;133:429–435. CrossRefGoogle ScholarPubMed
Montgomery, SA, Asberg, M.A new depression scale designed to be sensitive to change. Br J Psychiatry 1979;134:382–389. CrossRefGoogle ScholarPubMed
Guy, W.Clinical global impressions scale. In: New Clinical Drug Evaluation Unit (ECDEU) Assessment Manual for Psychopharmacology. Rockville, MD: US National Institutes of Mental Health, 1976: 218–222. Google Scholar
Simpson, GM, Angus, JW.A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl 1970;212:11–19. CrossRefGoogle ScholarPubMed
Barnes, TR.A rating scale for drug-induced akathisia. Br J Psychiatry 1989;154:672–676. CrossRefGoogle ScholarPubMed
Guy, W.Abnormal involuntary movement scale. In: New Clinical Drug Evaluation Unit (ECDEU) Assessment Manual for Psychopharmacology. Rockville, MD: US National Institutes of Mental Health, 1976: 534–537. Google Scholar
American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 4th edn. Washington, DC, American Psychiatric Association, 2000. Google Scholar
Lejoyeux, M, Gorwood, P, Stalla-Bourdillon, A, Ades, J.Traduction et utilisation de l’echelle de Simpson et Angus de symptomes extra-pyramidaux. Encephale 1993;19:17–21. Google Scholar
Munetz, MR, Benjamin, S.How to examine patients using the abnormal involuntary movement scale. Hosp Community Psychiatry 1988;39:1172–1177. Google ScholarPubMed
Gharabawi, GM, Bossie, CA, Lasser, RAet al. Abnormal Involuntary Movement Scale (AIMS) and Extrapyramidal Symptom Rating Scale (ESRS): cross-scale comparison in assessing tardive dyskinesia. Schizophr Res 2005;77:119–128. CrossRefGoogle ScholarPubMed
Keck, PE Jr, McElroy, SL, Strakowski, SM, Bourne, ML, West, SA.Compliance with maintenance treatment in bipolar disorder. Psychopharmacol Bull 1997;33:87–91. Google ScholarPubMed
Lingam, R, Scott, J.Treatment non-adherence in affective disorders. Acta Psychiatr Scand 2002;105:164–172. CrossRefGoogle ScholarPubMed
Esparon, J, Kolloori, J, Naylor, GJet al. Comparison of the prophylactic action of flupenthixol with placebo in lithium treated manic-depressive patients. Br J Psychiatry 1986;148:723–725. CrossRefGoogle ScholarPubMed
Yatham, LN, Fallu, A, Binder, CE.A 6-month randomized open-label comparison of continuation of oral atypical antipsychotic therapy or switch to long acting injectable risperidone in patients with bipolar disorder. Acta Psychiatr Scand Suppl 2007;434:50–56. CrossRefGoogle Scholar
Weiden, J, Preskorn, SH.Translating the psychopharmacology of antipsychotics to individualized treatment for severe mental illness: a roadmap. J Clin Psychiatry 2007;68(Suppl. 7):27–33. Google ScholarPubMed
Lasser, RA, Schooler, NR, Kujawa, Met al. A new psychosocial tool for gaining patient understanding and acceptance of long-acting injectable antipsychotic therapy. Psychiatry (Edgemont) 2009;6:22–27. Google ScholarPubMed
Macfadden, W, Alphs, L, Haskins, JTet al. A randomized, double-blind, placebo-controlled study of maintenance treatment with adjunctive risperidone long-acting therapy in patients with bipolar I disorder who relapse frequently. Bipolar Disord 2009;11:827–839. CrossRefGoogle ScholarPubMed
Yatham, LN, Kennedy, SH, Schaffer, Aet al. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update 2009. Bipolar Disord 2009;11:225–255. CrossRefGoogle Scholar